The Canadian MS Bone Marrow Transplant Research Study is a MS Society-funded project to re-grow the immune systems of patients with MS using stem cells. Led by Drs. Mark Freedman and Harold Atkins at the Ottawa Hospital Research Institute and University of Ottawa, the study began in August of 2000. Ten years later, more than half of the 26 patients enrolled have seen their symptoms stabilize and, in many cases, actually improve, unheard of results in the treatment of MS. Yet few people know about this research. As part of our month-long salute to MS and stem cells, we will speak with people involved in every aspect of this study: the doctors and researchers, patients and their families and the people behind the scenes. Today, an interview with Marjorie Bowman, RN, the Research Coordinator for the study.
A: The study is headed by Dr. Harry Atkins and Dr. Mark Freedman, though there are many people involved. Dr. Atkins is the bone marrow transplant physician, he oversees the stem cell transplants; Dr. Freedman is a neurologist who specializes in MS; and I’m the Research Coordinator. We’ve all been involved in the study from the very beginning, and my role has evolved quite a bit over the past 10 years.
At the very beginning, my job was to get the study up and running — submitting and getting approval from the ethics board — which is a huge process; developing all the data collection tools and forms, and getting everything set up within the hospital. It was big learning experience for everyone involved because the clinics at the hospital hadn’t done a lot of research transplants, so it was very different.
Another big part of my job early in the study was screening and speaking to potential patients. When we received the grant from the MS Society of Canada, there was a big announcement on their website and word spread quickly among the MS community. When I started my position, the MS Clinic had been keeping a list of all the people who had called to inquire about the study. So I had this list of patients that I had to contact and screen. There were 20 patients on this list. With a lot of the inquiries, you know right away that they’re not going to meet the criteria, but you still have to speak with them and explain the trial.
And that was the first year. We developed the protocol, and got everything in place. The first patient received a transplant in October of 2001.
Q: What was it like once you started seeing patients?
A: With the first patient, it was a matter of working through the protocol we had developed step by step, and it was a big learning experience. The protocol has evolved with the study, and we’ve kept up with changes in treatment and technology.
Pre-transplant, we did all the screening. We had to make sure the patient met all the inclusion criteria, and then go through the consent form with them and have them sign it, which is a process. The patients had two counseling sessions prior to signing the consent form, one with Dr. Atkins and one with Dr. Freedman.
Then, the patient goes for a first baseline visit, where they have all the neurological testing and blood work done, and then safety testing to see if they are a good candidate for the study. If they had any illnesses besides MS, they were excluded from the study. So we were testing the heart, lungs, things like that. I coordinated all that, all the testing and visits. I worked very closely with the patients during this process and got to know them very well.
Once they got to the transplant phase of the study, they were turned over to the bone marrow transplant team at The Ottawa Hospital. During that time, I was the first point of contact if they had any problems.
Once they had been through the transplant, I coordinated post-transplant testing. All the patients have to have lumbar punctures and MRI and MRS scans once a year, plus lots of neurological testing. I was kind of overseeing all that testing.
In the meantime, I was still screening patients and talking to potential patients from all over Canada. And that’s something we didn’t expect. The people from out of town need a little extra support to get here and go through the trial. And there were some very brave, dedicated patients for sure.
Q: How many patients have gone through the trial and how much information are you collecting?
A: Of the 26 patients that have gone through the trial, 24 have actually received stem cell transplants. We have 2 control patients — they had the same inclusion criteria but refused the transplant, and we’ve been following them closely to see how their symptoms compare with those who have received a transplant.
In 2008, we received another grant from the MS Society to follow these patients even further. Originally we followed patients for three years after their transplants. But the investigators weren’t satisfied with only three years. They wanted to follow them longer because we need to see that their MS is stable for a sustained period of time. So, we’re now going to be following the patients until 2012. It’s been such a range of time, because the first patient received a transplant in 2001 and the most recent patient received one in December of 2009. So the last patient will have a three year follow up, but the first will have 11 years. It’s great to be able to follow them for so long and to see the changes.
It’s interesting, my role has evolved with the study, now that the transplants are done, compiling and analyzing the data is a bigger part of my job. We’ve collected literally rooms worth of data on the patients. I have four two-inch binders on each patient, so it’s a lot.
We’re working on compiling all of it right now and preparing to present our findings. We’re going to be publishing for the next 10 years by the looks of it, and we’re hoping to publish our first paper in the fall.
Q: What kind of results have you seen?
A: So, this is kind of a summary: we’ve seen stabilization in many of the patients, which was our goal. It has been exiciting to see improvments in some patients. Some have been able to walk without mobility aids, many have experienced decreased fatigue. Some have returned to work and are now focusing on new goals. After getting to know these patients so well, seeing the improvement in their quality of life has been surprising and rewarding for me.
Q: What has been the most rewarding aspect of working on this study?
A: The most rewarding part of the study has been the patients. Just getting to know them and helping them through this trial has been fantastic. Whenever I was having a bad day, I would think about what these patients were doing and what they were going through.
Q: What are your hopes for the future of the study?
A: I hope that this will become standard care for MS, though of course it’s not for everyone. Dr. Atkins has said that only 5-10 % of MS patients would benefit from this kind of treatment.
But there have been a number of interesting findings, not all strictly related to the transplant. One thing I’m hoping the data from the study will show is that we don’t need to give MS patients so many immunosuppressants, so maybe it’ll lead to less toxic therapies for all MS patients.
Marjorie Bowman is the mother of two young children. She enjoys reading and playing shinny.