Great, and if you have something to say, just let me know. I'll give you a chance to present during the course of the morning. We won't forget about you; even though we can't see you, we can hear you. Thank you for joining us.
We now have with us, from the Alberta Cord Blood Bank, Dr. John Akabutu, the executive medical director. Welcome. I'm glad you could be here.
We have, from Canadian Blood Services, Dr. Graham Sher, chief executive officer. Welcome. We also have Jean-Paul Bédard, vice-president of public affairs, and Jennifer Philippe, director, from the OneMatch stem cell and marrow network. It's wonderful to see you again. We quite enjoyed the time we have with you at our awareness campaign here on Parliament Hill, when some of you joined us here. Thank you for that.
We have a very special person here this morning—to my family anyway—Dr. Morel Rubinger, associate professor of medicine, University of Manitoba. Thank you so much, Dr. Rubinger, for coming today.
From the Department of Health, we have Liz Anne Gillham-Eisen, manager, blood, cells, tissues, organs and xenografts, office of policy and international collaboration of the biologics and genetic therapies directorate. Welcome, and my goodness that's a long title.
Voices: Oh, oh!
The Chair: I think I'm going to have to give you an acronym or something. Welcome. We're very glad that you're here.
I'll be speaking, Madam Chair. Thank you very much.
Good morning, members of the committee. I'm Graham Sher, the chief executive officer of Canadian Blood Services, which is the organization responsible for managing the blood system in all provinces and territories of Canada, except for the province of Quebec. We are also responsible for managing, in addition to the blood program, the plasma program and, of particular relevance to today's committee, the OneMatch stem cell and marrow network.
I'd like to thank you, in particular, Madam Chair, for the invitation to attend today's committee and for your very strong personal interest in the topic of stem cell transplantation. I'm pleased to be able to talk to the committee this morning about stem cell donation in Canada, and specifically about the probability and possibility of creating a national public umbilical cord blood bank for the country.
As many of you in this committee know, stem cell transplants are used to treat patients who have certain cancers or life-threatening immune disorders and some metabolic and other genetic disorders. Unfortunately, only about one-quarter, 25%, of patients actually have a match within their own family, and therefore, every year, hundreds of Canadians require stem cell transplants and have to depend on the program, OneMatch, to find them a suitable donor.
To that end, OneMatch recruits and maintains a registry of prospective Canadian stem cell donors. When a patient requires a stem cell transplant, at the request of their physician, they search the OneMatch registry to identify potential matching donors. Because OneMatch is a member with accredited international organizations, we are able to search over 14 million donors worldwide, from 63 other registries in 44 countries, and we're able to search 44 cord blood banks in 26 countries worldwide, in addition to our own registry in Canada.
OneMatch's role is to ensure that the volunteer donors are healthy and able to donate, and then we organize the collection and the delivery of stem cells in Canada and around the world when a suitable match is found between a Canadian patient and a donor. In addition, OneMatch actually serves the purpose of enabling searches for international patients from our Canadian registry, making this a truly international system.
However, finding a match for a patient in need is often very challenging because of how closely the donor stem cells have to match the tissue type of the patient. It often requires what is called an HLA, human leukocyte antigen, match and ideally you want a 10-point match. HLAs are the genetic markers that are used to find the best stem cell donor for a particular patient. This requirement is really at the heart of what we're talking about here today.
Canada is one of the few G-20 countries without a national cord blood bank. An ethnically diverse, national public cord blood bank is needed in Canada. Having this important resource in place for Canadians would offer several benefits: it would save more Canadian lives; it would allow for greater matching possibilities because cord blood does not always require the rigorous match that other stem cells such as bone marrow and blood stem cells may require; it causes fewer complications to do transplants from cord blood, particularly a complication known as graft versus host disease; and it helps meet the rapidly growing demand for cord blood stem cells in general.
In fact, consistent with worldwide trends, OneMatch continues to see a significant shift in demand for products away from bone marrow and peripheral blood stem cells toward patients and physicians, particularly physicians, requesting cord blood stem cells.
In addition, a Canadian cord blood bank would better represent the unique ethnic diversity that makes up this country and would decrease the risks and costs associated with the 100% reliance on international sources for cord blood stem cells.
As I mentioned earlier, Canadian Blood Services is the organization that operates the national blood system across this country, except in Quebec. In recognition of CBS's established quality and regulatory infrastructure, our accredited and licensed testing laboratories, our experience in donor recruitment in stem cell processing, and the fact that we are national in scope and accountable to the provinces and the public, and we have credibility with links to Canadian and international stem cell communities, with all of those factors in mind, the provincial and territorial ministers of health responsible for the delivery of health services asked Canadian Blood Services to investigate the possibility of a national cord blood bank for Canada. In response to this request, we prepared and submitted the results of a study, including recommendations for the establishment of a national public cord blood bank in Canada. Following discussions and further requests from the ministers, we submitted to them a detailed business plan for this cord blood bank.
After extensive public consultation across the country to discuss the issues and share knowledge, key learnings, and best practices, our plan was submitted to the provinces and territories outlining a comprehensive national model, including two accredited stem cell laboratories and a collection network right across the country. It would be managed by Canadian Blood Services through our national stem cell program, OneMatch. We would be an active contributor to the global stem cell community, joining those other 44 cord blood banks I mentioned earlier and being able to contribute to the 450,000 cord blood units available worldwide today.
As mentioned earlier, this plan leverages Canadian Blood Services' established infrastructure and foundation in support of a national public cord blood bank. To be more specific, our organization already manages the OneMatch network, which currently searches matches and acquires cord blood for patients in this country. We have experience in the collection, processing, and storage of stem cells. We are experienced at meeting regulatory requirements, including the Foundation for Accreditation of Cellular Therapies, which is an international accreditation standard that we already have in our laboratories.
We have established partnerships with hospitals across this country. We are successful in our blood program in recruiting ethnically diverse donors, and we have extensive experience in understanding stem cell requirements of physicians. We have the infrastructure and the expertise necessary to support the creation and maintenance of quality and regulatory standards, privacy, medical, scientific, information technology, and the legal and financial resources to support a public cord blood bank.
Further, we believe that a centralized national model for cord blood banks in Canada would best be able to meet the needs of Canadian patients by providing the diverse tissue type--HLA type--searchable, accredited, cord blood bank that reflects the ethnic diversity of Canada. It would be used not only by physicians and patients in this country, but by physicians and patients internationally.
One of the primary goals stated in our plan for the national public cord blood bank is to collect and store a diverse inventory to serve the needs of the entire Canadian population, in particular and including the aboriginal population in Canada. To achieve this, our recommended national model includes collection sites in the ethnically diverse provinces and cities in Canada. We would apply the key learnings from the successful recruitment campaigns we already have in OneMatch to help recruit these ethnic donors.
On the size of the bank, in our model we are proposing a bank of 20,000 cord blood units, based on the estimates of Canadian subject matter experts who have suggested that a bank in this country needs to range somewhere between 10,000 and 30,000 units. Our plan focuses on continued reliance on the medical and scientific expertise within the Canadian stem cell transplant and research community.
In June 2009, this plan for the 20,000 cord blood bank samples was unanimously approved by the ministers of health in all the provinces and territories, excluding Quebec, pending funding approval.
This morning, we are going to try to answer two fundamental questions.
But first of all, on behalf of Héma-Québec, I would like to thank Madam Chair and the committee for the opportunity to be here today. We are very grateful.
So Héma-Québec will speak to two issues this morning. The first has to do with the feasibility of establishing a Canada-wide public cord blood bank, and the second pertains to the establishment of a registry of stem cell donors.
I would like to share with you Héma-Québec's mission: to efficiently provide adequate quantities of safe, optimal blood components and substitutes, human tissues and cord blood to meet the needs of the population.
I want to make it clear, from the outset, that Héma-Québec is already involved in Canada's human tissue sector. Héma-Québec has been distributing human tissues, tendons, skin and bones throughout Canada for a number of years now.
Furthermore, we provide and develop expertise, along with specialized and innovative products and services, in the field of transfusion medicine and human tissue transplantation.
Now I want to address the first issue, regarding the establishment of a stem cell donor registry. As Dr. Sher pointed out, a Canadian registry already exists: the OneMatch network. Canadian Blood Services administers the registry, but Héma-Québec also contributes on two levels: it helps recruit donors and assumes a portion of the overhead costs.
The Canadian registry comprises more than 265,000 individuals across Canada who have already made this generous commitment, including 36,000 in Quebec. Many people owe their lives to the millions of men and women listed in registries around the world. Keep in mind that the registry, together with various other public banks, is part of a worldwide registry. It is part of a joint effort and must be seen from a global perspective, not a local one.
I would like to pick up on some statistics mentioned by my colleague earlier. There are indeed 64 registries of unrelated donors in 44 participating countries, and 44 public cord blood banks in 26 participating countries. Today, there are more than 15 million donors, contributing to an inventory of 447,184 cord blood units around the world.
That figure, 447,184, bears repeating because the number put forward at the committee's November 2nd meeting was 600,000. The cord blood industry, if you want to call it that, is still fairly young, and the international inventory does not yet contain very many units. That is what we are all working on.
Take the figures for the Canadian registry, which Héma-Québec contributes to. Those 266,000 or so unrelated donors make up approximately 1.8% of donors worldwide, despite numerous efforts over many years. But it is important to consider Canada's efforts as a whole. It is 1.8% despite how incredibly well the network and Héma-Québec have performed, at the national level.
Now let's look at Héma-Québec's public cord blood bank. As of November 16, we had 4,202 cord blood units in inventory, which represents 0.9%, or close to 1%, of the worldwide inventory. I should point out, as we will see a bit further on, that we did not start operating until 2004. So our bank is not very old, as mentioned at the meeting on November 2. Nevertheless, we contribute to the inventory at a rapid rate. I would also point out that ours is a very active bank.
Back to the public cord blood bank. It fits into a very well-developed strategic and business plan, which has been in place for a number of years. We started up in 2004, as I mentioned earlier. We had our first distributions in 2009. So we were able to start distributing cord blood units five years after we began building our inventory.
Why does it take so many years? Because you need enough units in the inventory. You cannot start distributing cord blood units with only 500, 1,000 or 1,500 units in the bank. The bank's inventory has to contain a certain number of units to be of use internationally.
It is also worth noting that Héma-Québec must hold a federally issued establishment licence and is therefore subject to the Safety of Human Cells, Tissues and Organs for Transplantation Regulations, or the CTO regulations. So, as required, we hold an establishment licence to process and distribute cord blood in Canada.
In addition, we rely on two medical directors, Dr. André Lebrun, who is here this morning, and Dr. Martin Champagne, who you should know is one of Canada's most experienced transplant specialists. Known around the country, he is certainly among those who have performed the largest number of transplants in Canada.
Of course, Héma-Québec's public cord blood bank relies on partnerships. In terms of recruitment, we have agreements with a number of partner hospitals. In our presentation, we list seven hospital centres that we partner with in Quebec, including Sainte-Justine, an institution we began working with back in 2004.
There is also a research component to our work. It is always necessary to consider the therapeutic uses of cord blood, but those kinds of advances require research. So Héma-Québec supports a great deal of research. We currently have research agreements with five of our seven hospital partners. When cord blood units do not meet inventory qualifications, they are sent back to the hospital centre, where they can be used for a variety of research projects.
Next, we formed a partnership with St. Mary's hospital, also in 2004, and with the Royal Victoria in September 2007. We went on to forge partnerships with the Centre mère-enfant in Quebec City, Cité de la Santé, Ville LaSalle and Saint-François d'Assise, our most recently acquired partner, in 2008.
Starting up a public cord blood bank requires considerable investment. Nearly $20 million has been invested in Héma-Québec's bank since it began. We anticipate that, by March 31, we will have spent nearly $20 million to put 5,000 units in our inventory. So then you can appreciate that putting 20,000 to 50,000 units in the bank would truly require a huge investment at the national level.
The cord blood inventory in the U.S. grew at a rate of 49% over 2 years, 2007 to 2009. The worldwide inventory is also growing quickly, and Héma-Québec is keeping up with that pace. Between 2008 and 2010, our inventory grew at a rate of 66% over 2 full years. We are on track with worldwide growth. We have a duty to contribute high-quality units that meet international standards, and to do so at a rapid rate in order to respond to a variety of needs.
There are few cord blood transplants in Canada. In 2008-09, a total of 76 transplants were performed in the entire country. In 2009-10, there were 90, and the units for 4 of those transplants were supplied by Héma-Québec. In 2010-11, that number dropped to 30, as of the end of October. Out of those cases, the blood units were drawn from the worldwide inventory for 25 of the transplants and from Héma-Québec's public cord blood bank for the remaining 5. The cord blood we distributed in the province for those 5 transplants represents 30% of the cord blood transplanted in Quebec and 17% of the blood transplanted nationwide.
Our recommendation is to continue developing Canada's main public umbilical cord blood bank so that it is representative of the population. Héma-Québec has the ability to develop a public bank with an inventory ranging from 20,000 to 50,000 units of cord blood. We agree with the figure cited by Dr. Wall on November 2, in terms of establishing a national bank with an inventory of 20,000 to 50,000 units of cord blood. We estimate that the inventory will hit 20,000 cord blood units sometime in 2015 or 2016, in other words, in the very near future.
I wish to thank the committee for inviting me to speak to this important issue in the role of a transplant physician.
When I am facing a patient who has reached the point of requiring a stem cell transplant, and if no family donor has been found, I am asked, with tremendous hope but also with a high level of anxiety, “Doctor, what is my chance of finding a donor in the registry?” How much more rewarding would our task be and how much more would a patient appreciate it if the answer would always be, “I can reassure you, there is a high likelihood that we will be able to find a donor for you in the right frame of time.”
Unfortunately, we have not reached this stage. We hope to get there soon.
Hematopoietic stem cell transplantation, known also as a blood and marrow transplantation, is a curity procedure for life-threatening blood cancers and other bone marrow disorders. The single most important donor factor in determining transplant outcomes is a degree of matching known as HLA matching, or, in other words, the immune equivalent of the fingerprint match between the patient and the donor.
There is approximately a 25% chance that two siblings inherit the same immune fingerprints, which translates to only a probability of 30% that someone will have a suitable sibling match in a family, mainly due to the small size of Canadian families. Thus, donation of hematopoietic stem cells from an unrelated donor has become the only available option for 70% of patients in need of unrelated stem cell transplants.
The success of securing an unrelated stem cell donor for a particular patient depends on many factors, but the very important one is the ethnic background of the patient. The smaller the ethnic group the patient belongs to, the less likely such a patient will find a suitable donor in any registry, including the Canadian registry, as their representation in the donor group is significantly lower.
Stem cell transplantation is often the last hope for a curative option for these patients. Their disease is at the point at which no better alternative exists. The waiting period for a search to complete, the hope that they will be the lucky one to find a suitable donor, and the potential curative nature of the procedure hangs heavy in a patient's mind.
The ability to tell a patient that we have found a donor is always emotionally charged and rewarding. It is among the best news the patient can get when transplantation is needed. The reverse is heart-wrenching, for the patient and their family, and it leaves us, their physicians, with a sense that we have not done enough for their well-being.
In order to find the best available donor, individual donor registries collaborate internationally. However, despite the number of adult donors already registered, many patients in need of a stem cell transplant still cannot find an acceptable donor because they have a rare tissue type.
In 2008, there were 10,400 adult stem cell donations and 3,500 cord products were used. Through these global efforts over the years, a total of 100,000 patients have received stem cell transplants worldwide.
Despite these heartening figures, many patients remain unable to find a suitable stem cell donor within their own country's registry. Thus, the percentage of products crossing international borders has increased over time. In 1997, 30% of products crossed an international border, and this grew to 44% in 2008.
Currently, as mentioned before, there are over 14.9 million registered unrelated donors and 450,000 blood unit cord banked worldwide. However, the number of donors in Canada is smaller. In Canada, the OneMatch stem cell and marrow network, under the auspices of Canadian Blood Services, is responsible for finding and matching volunteer donors for patients who require stem cell transplants. OneMatch maintains a detailed database of tissue typing results of all prospective Canadian donors. The ethnic composition of OneMatch, including Héma-Québec, is 81% Caucasian, 15% ethnically diverse, including a total of 266,000 donors who comprise about 1% of the Canadian population.
The age of recruited donors is also becoming important. On the basis of published data describing that the use of younger donors may lower the incidence of complications from transplantation and improve survival, some registries have recently started to focus recruitment on younger donors. There is a particular need to increase younger registrants and those from ethnically diverse backgrounds.
Concomitantly, an increase in the availability of cord blood units will act synergistically in enhancing the ability to find a suitable donor for patients. Cord blood units are more likely than any other source of stem cells to expand rapidly, because of cord blood's wide availability and ease of collection, with no major burden to the donors.
The specific benefit of cord blood units is that a lesser degree of matching is acceptable and leads to clinical outcomes similar to those in which unrelated donors are used. These units are fast becoming a significant stem cell source for patients who cannot find a suitable donor within the unrelated donors registry.
The process of stem cell donation has changed significantly over time, over the last year particularly. While bone marrow is a rich source of stem cells, the ability to collect stem cells from peripheral blood, also known as peripheral blood stem cells, and from umbilical cord blood has changed the way we obtain stem cells today.
Because the donation of peripheral blood stem cells does not require a surgical procedure, is efficient, and is more acceptable to donors, it has become the predominant form of stem cell collection worldwide. Unlike the donation of organs such as kidneys, the donation of peripheral stem cells is much less complex, both technically and psychologically. The stem cells are a renewable source, and donating them is only slightly more complicated than donating blood. However, the benefit is similar to donating any other important organ or tissue: the benefit of saving a life.
The altruistic nature of people willing to donate stem cells has to be highly appreciated, and their safety has to be properly ensured. Donor safety must be a priority, and they should not be asked to take unacceptable risks. Any medical and psychological condition that increases the risk to a donor has to be thoroughly investigated, resulting in either deferral or approval for donation.
I will make some concluding remarks.
In 2008, among 462 transplants done in Canada using a stem cell donor, 179 received a stem cell transplant from an unrelated donor, including umbilical cord blood.
Unfortunately, I do not have the number of unsuccessful searches and as such the number of patients who could not find a stem cell donor and could not be rescued by this procedure. The ability of every Canadian patient who requires a stem cell transplant to find a suitable donor is an important goal that we should strive to achieve. The ability to do so resides in having all the stakeholders work together towards this common goal.
Some of the measures to achieve this important goal should include: a focus on the increasing enrolment of ethnic minorities and mixed minorities; a focus on the increased enrolment of younger donors, aged 18 to 35, as the youth of their stem cells can lead to better transplant outcomes, as published; the establishment of a national cord blood bank in Canada, ethnically diverse, which would be a complementary and long-awaited stem cell source for many patients who cannot find an unrelated donor match; increased funding for research in the area of mismatched donor transplantation, to establish whether manipulation, a graft, and/or the recipient's immune system can lead to improvement in clinical outcomes; continuing the present efforts and adopting new ways to increase awareness among the Canadian public about the importance of becoming a stem cell donor; and perhaps increasing funding to allow for the thorough and accurate reporting of the outcomes of stem cell transplants to the Canadian Blood and Marrow Transplant Group, the only group that collects this clinical data, which in turn might lead to improvements in transplantation outcomes.
As transplant physicians, we would like to be able to offer to any patient in need of a stem cell transplant a suitable donor match that would improve his or her chances of survival and ultimately lead to a long, happy, and productive life. I hope we will be able to accomplish this through our present meeting and other future endeavours.
Thank you, Madam Chairman and members of the committee.
This is my first time appearing before a House of Commons committee, so pardon me if I appear nervous. I am a teacher, so I can stand in front of 200 unruly students and be able to handle them well, but when I get into situations like this, I seem to get very nervous.
My presentation is going to be very brief and non-technical. I want to tell you a story about the Alberta Cord Blood Bank and how we developed a cord blood bank in Alberta.
Our story with cord blood banking began with a little girl in the town of Eckville, Alberta, who I was treating--I am a pediatric hematologist oncologist--for acute lymphoblastic leukemia. She successfully entered remission, but after 18 months she failed. This was in the late 1980s.
Even then we recognized that the only chance of survival for this little girl would be a bone marrow transplantation or, in latter days, a stem cell transplantation. The people in the town of Eckville heard this story and heard about this child, and they decided they wanted to do something about this to ensure that we could find a stem cell donor for her anywhere in the world. They got together and raised funds, and they donated $35,000 to us to look for a transplant source for her.
Unfortunately for her there were no matches in her family. So we approached our colleagues at the University of Minnesota, who looked worldwide for us for a donor for this little girl. None was found and so she died.
In the same year, the townspeople decided that even though she had passed away, they would continue with this fund, hoping that one day it might be useful. They approached the provincial Government of Alberta and got it matched two to one. We had over $100,000 at the time but nothing to do with it.
Then in 1995 I was part of a site visit committee for the National Institutes of Health, and I happened to visit Columbia Presbyterian Hospital in New York, where a Canadian transplant physician, Dr. Blanche Alter, was working. I was the one who reviewed her grant, and it was on the use of cord blood stem cells for the therapy of sickle cell disease. I read that, and I was enthused and amazed at the fact that cord blood stem cells could be used to cure sickle cell disease.
At the meeting, she and I had a conversation, and she encouraged me to get into the field of cord blood banking, because she felt there was a big future in cord blood banking, not just for the treatment of leukemia but for other things.
On my return to Edmonton, I met with Dr. Locksley McGann, who is the foremost authority in Canada on the cryopreservation of mammalian cells, as far as I know, and Dr. Hongyou Yang, a specialist in cryopreservation. We tossed around the idea of developing a public cord blood bank. We spent eight months looking at the logistics of doing this and decided at the end of eight months that it was possible to do. So at the end of that period, we began banking cord blood, and our first cord blood was banked in October 1996, on my birthday.
We have now collected over 10,000 samples of cord blood specimen from across Canada. I have to tell you that it's amazing how generous Canadian mothers and parents are and how they want to help somebody else who might be in need. Canadian physicians across the nation have also been wonderful. None of them has ever asked to be paid for collecting cord blood for our program.
We chose to extend our program across Canada, as you have heard from the previous speakers, based on the fact that we believed that collecting cord blood across Canada would represent the ethnic diversity of the nation, that this was the best way to go. This is true, again, because when you look at the genetics of Canada's aboriginal population, they are unique. And you're not going to find stem cell donors from the registries for that group of patients, but you might find cord blood donors from them if we were successful in collecting cord blood from the deliveries among the aboriginal population.
Our interest in cord blood banking is twofold.
The first is that we agree and believe that cord blood stem cell transplantation is probably going to become the therapy of choice in stem cell transplantation. As has been pointed out before, the morbidity associated with cord blood transplantation is reduced, but the efficacy remains high. So it makes sense to pursue that avenue.
The second reason that cord blood transplantation might become more important is because even today, we are beginning to use cord blood stem cells in adults, and recently there has been the advent of using two cord blood stem cell transplantations because of the larger size of the adult. These seem to be working very well. Our second reason for wanting to bank cord blood stem cells comes from the fact that these stem cells come from an inexhaustible source, and we believe that at a future date they will form a very important component of the stem cells that we might need for treatment with regenerative medicine.
In my days as a pediatric hematologist oncologist treating children with cancer, I had three methods to treat them: cut it out, burn it, or poison them. When you think about it that way, you surely have to say to yourself, “There must be better ways to treat these children.” And lo and behold, it may seem possible that in the future, using stem cells we might indeed be able to repair, rather than do the things that we have been doing in the past. We believe that cord blood stem cells will form a major component of stem cell use in the future.
Madam Chair, I would like to conclude by quoting a favourite quote of mine from George Bernard Shaw, and this tells you why we did what we did. He said, “You see things; and you say, 'Why?' But I dream things that never were; and I say, 'Why not?'”
Thank you very much, Madam Chair and committee. I'll be brief.
I'm speaking as a pediatric blood and marrow transplant physician who uses cord blood as the primary choice of stem cells for transplant in children who do not have a donor in the family, and also as a person who's been active in the field of cord blood banking and regulation for over 15 years, having started both the St. Louis Cord Blood Bank and the Texas Cord Blood Bank, and being active in the Foundation for the Accreditation of Cellular Therapy.
My previous colleagues have made a very eloquent case for the need for a cord blood banking system in Canada. The points I'd like to accentuate at this time are as follows.
One, a cord blood bank in Canada needs to be known for its quality. There are very strict international regulatory standards that have been established, and it's critical that we be known as a bank with very high standards.
Second, just to be very direct, size matters. When we're doing a transplant, we need to have a large cord blood unit, meaning units that have the most cells possible contained in them. What that means in banking operations is that you need to develop a collection network and system that allows you to bank only the largest of the cord blood units.
The third point is that it is critical to have a variety of immune types--and you can put in the word “ethnicity”, since immune type and ethnicity go together. Where cord blood makes a difference in clinical practice is with our patients who are of mixed racial heritage or of ethnic minorities. With the establishment of a bank, we need to unabashedly target these populations for the bank. This means our first-generation Canadians, our multi-ethnic Canadians, and ethnic minorities. This is going to need a very creative network of cord blood collection.
We have a lot of the building blocks in place for an excellent cord blood collection banking system in Canada. We've heard from CBS. It has set up a tremendous network system for management of donors, putting transplant centres across the world together with donors across the world. There's no need to reinvent the wheel in that department. We have Héma-Québec, which has done a tremendous job in setting up a solid cord blood bank, as have colleagues in Alberta.
What we need are the funds to help pull all this together and take the banking operations up to the next level so that we can move to the forefront on the world stage. I've inspected banks around the world. Unfortunately, I have never had the privilege of inspecting a Canadian cord blood bank as part of the international accreditations, because we're just not quite there yet.
With those words, I'll submit my written document. I don't want to waste everyone's time by repeating a lot of the similar statements.
Thank you for the time.
Thank you very much, Madam Chair. I'd like to thank the chair and this committee for the opportunity to address you this morning--almost afternoon.
I'm here representing Health Canada. I've been asked to explain Health Canada's regulatory requirements with regard to cord blood banking. This is probably the boring side of the discussion. You've heard the very inspirational, and the need, and how important cord blood banking is in Canada, and I am very privileged to be sitting here with these individuals.
My presentation, again, is on the regulatory side. First of all, I'd like to take a minute to explain, in general, how the safety of stem cells is regulated in Canada. I was present at your initial hearings on stem cell donation, which you held on November 2, I believe, and I think there may be some confusion around the regulatory oversight of stem cell therapies.
Stem cells, as you know and as you've heard, can be produced from a variety of sources, including embryos, bone marrow, cord blood, adult skin, peripheral blood, etc. The Assisted Human Reproduction Act contains provisions governing the creation of embryos, including their use in research. In order to use stem cells derived from embryos for research, a facility will need to be licensed under Assisted Human Reproduction Canada, which, as you know, is the agency responsible for the AHR Act.
However, once a stem cell line has been established from an embryo, any clinical trials for new therapies using this stem cell line are subject to the requirements of the Food and Drugs Act and regulations, specifically division 5, which regulates the clinical trials and clinical trial applications.
Research involving stem cells sourced from other sources, such as cord blood and bone marrow, does not fall under the AHR Act. This research is subject only to the requirements of the Food and Drugs Act and regulations. There is also the Canadian Institutes for Health Research, which has developed guidance and created a national stem cell oversight committee to address all stem cells used in research.
Now I'd like to specifically speak to cord blood, which, as you've heard, is the blood that remains in the umbilical cord after birth. The retrieval of cord blood allows for the harvesting of stem cells, which can then be transplanted into patients to treat a variety of disorders, such as certain cancers and genetic diseases related to blood and blood cell formation.
Stem cells retrieved from cord blood may be transplanted into the same individual, which is considered autologous use, or into another individual, which is referred to as allogeneic use, provided the cells and the recipient are sufficiently matched.
Cord blood banking is the act of storing cord blood under controlled conditions for future use. Current technology enables storage of cord blood for many years. Public cord blood banks, for example, the Alberta program, as well as Héma-Québec, collect and store donated cord blood for use by unrelated patients. Information needed for matching can be listed on a registry so that this cord blood can be used to save the life of a potential recipient in Canada or elsewhere in the world.
Private cord blood banks collect and store babies' cord blood in return for a fee. Cord blood is banked for either autologous use, which is for that child himself or herself, or for allogeneic use, normally restricted to another family member.
Health Canada's role relating to cord blood pertains to the safety of the human cells derived from the umbilical cords that are used, or intended for use, in transplantation. Both public and private cord blood banks fall under the same set of regulations.
Cord blood is currently classified under the group of products known as cells, tissues, and organs, or CTOs. CTOs are considered to be therapeutic products, and as such they are subject to the provisions of the Food and Drugs Act. The act prohibits anyone from distributing cord blood, or its cells, if it has been prepared or collected under unsanitary conditions, is adulterated, or is likely to cause harm. Health Canada has the authority to enter cord blood facilities for investigational purposes and to stop distribution if necessary.
In December 2007, specific regulations for transplantation that apply to cord blood as well as other types of cells, tissues, and organs came into force. These regulations reference portions of the national standards for cells, tissues, and organs published by the Canadian Standards Association and funded by Health Canada. Cord blood establishments involved in the retrieval, processing, preservation, packaging, labelling, storage, quarantine, record-keeping, distribution, importation, adverse event reporting, investigation, and recall of cord blood for allogeneic use are required to comply with these regulations.
These cord blood banks are also required to register with Health Canada, and cord blood for allogeneic use can only be collected, stored, and distributed for use by banks with a valid Health Canada registration. If cord blood is used for a novel or experimental purpose, or extensively altered or manipulated prior to its use, other regulations under the Food and Drugs Act may also apply.
There are two public cord banks in Canada, and you've heard presentations from both of them, and there are ten private cord blood banks registered with Health Canada. The Health Products and Food Branch Inspectorate is in the process of inspecting these establishments to assess their compliance with the CTO regulations. As of today, one-third of the cord blood banks have been inspected, and Héma-Québec is one of them that has been inspected. All have received compliant ratings. The inspections of all registered Canadian CTO establishments, including the cord blood banks, should be completed by the end of next year. December 2011 is our goal.
As you are aware, both the Government of Canada and Canada's provincial and territorial governments have responsibilities in the area of health care. Delivery of health care, including the supply and sourcing of products used in the provision of health service, is a provincial responsibility and beyond federal authorities, with some exceptions. As such, the establishment of a national cord blood bank would have to be initiated and coordinated by provincial and territorial governments, despite the national scope.
Health Canada is aware that in 2007 the provincial and territorial ministers of health had asked Canadian Blood Services to study the feasibility of creating a national cord blood bank, and CBS concluded that Canada should have a national public umbilical cord bank, and you heard the results of that particular consultation from Dr. Sher.
I'd like to thank you once again for the opportunity to explain Health Canada's regulatory role with regard to cord blood banking and to clarify the federal regulatory oversight with regard to stem cell therapies.
The issue of having younger donors arises from the fact that the outcomes of transplantation--rejection, etc.--are much lower in patients who receive such a transplant, so I think the impetus in registering those potential donors has to go to that kind of population, i.e., schools, universities, drives, in which this population is made aware of the benefits of stem cell donation and the ease of stem cell donation.
I had a conversation with my kids over the weekend about that and both have already registered, without any kind of incentive. So what I'm saying is that you have to convince people that, yes, it is something good to do, easy to do, takes little time, and is renewable. The stem cells are renewed very quickly. You recover and do well after that. And you can save a life by doing this.
So getting drives in the right population age is important. The attrition rate of the banks, when you get to age 40 or 50, is very high, so we're losing a lot of donors. As I say, schools--even high schools--and universities should be targeted, and of course ethnic groups in a different format, be that through cultural or other events.
I'd like it to be changed to, “That the Committee recommend that the federal government increase support” and take out “financial”. That would encompass all the ways that Health Canada supports this.
Then we would change the final words that Kirsty originally had, “globally competitive levels”, to “ensure that Canada remains globally competitive”.
I'd like to review some rationale here. First of all, we'd like to agree that stem cell research can potentially lead to useful therapies in the treatment of health conditions and diseases such as Alzheimer's, Parkinson's, diabetes, kidney failure, heart disease, and spinal cord injury. The government recognizes that clinical therapies based on the properties of stem cells have the potential to revolutionize the treatment of degenerative diseases and major traumatic injuries, thus improving the quality and length of life for Canadians.
That is why the Government of Canada has provided significant support for stem cell research through the Canadian Institutes of Health Research. For example, in 2009-10 CIHR invested approximately $41.5 million in stem cell research, which is up from $8 million in 2000. So we're already seeing a huge increase there. In Budget 2010, the Government of Canada increased the budget of CIHR globally by $16 million, so the CIHR total budget in 2010-11 will exceed $1 billion. This financial commitment signals the importance that the government places on all health research, including stem cell research, for its contribution to improved health for Canadians. Even Dr. John Akabutu mentioned that's where he thought the priority should be going from the federal government.
The Government of Canada, through CIHR, will continue to support the Canadian researchers who are increasing our understanding of stem cells through their work and will build on the findings of the international research community to promote the development of stem cell therapies.
Finally, it's important to note that CIHR is actively working at enhancing Canada's clinical trial capacity through its recently launched strategy for patient-oriented research. Once implemented, this strategy will help address key infrastructure and research environment needs that include large-scale clinical trials--which is what we heard today--so that Canadian researchers may better identify and tackle these health gaps.