Clinical Trials
Linda M mentions several other protocols for Stem Cell Transplant (STC) in the previous post. I wanted to know more. If you do also, here ya’ go:
Cyclophosphamide and rATG/Rituximab in Patients With Systemic Lupus Erythematosus
webpage: [url]http://clinicaltrials.gov/ct2/show/NCT00278538?term=lupus+chicago&rank=13[/url]
Stem Cell Therapy for Patients With Multiple Sclerosis Failing Interferon A Randomized Study
webpage: [url]http://clinicaltrials.gov/ct2/show/NCT00273364?term=ms+chicago&rank=3[/url]
Phase I Study of High-Dose Cyclophosphamide and Total Body Irradiation With T Lymphocyte-Depleted Autologous Peripheral Blood Stem Cell or Bone Marrow Rescue in Patients With Multiple Sclerosis
webpage: [url]http://clinicaltrials.gov/ct2/show/NCT00017628?term=ms+chicago&rank=24[/url]
Immunological Mechanisms of Hematopoietic Stem Cell Transplantation in Multiple Sclerosis
webpage: [url]http://clinicaltrials.gov/ct2/show/NCT00342134?term=ms+chicago&rank=30[/url]
Autologous Stem Cell Transplantation for Crohn’s Disease
webpage: [url]http://clinicaltrials.gov/ct2/show/NCT00692939?term=crohns+stem+cell&rank=1[/url]
ASTIC Autologous Stem Cell Transplantation for Crohn’s Disease
webpage: [url]http://clinicaltrials.gov/ct2/show/NCT00297193?term=crohns+stem+cell&rank=4[/url]
Crohn’s Disease Stem Cell Transplantation
webpage: [url]http://clinicaltrials.gov/ct2/show/NCT00271947?term=crohns+stem+cell&rank=5[/url]
ok ok I get it, that’s enough. If you are interested check it out. It’s fair to say there are a “few” studies going on. Some are in Chicago, some are not. Some are actively recruiting, some are not.
Clinical Trials
A clinical trial is not about curing or treating any particular patient, or even a group of patients. It is about determining if the proposed treatment is safe and effective. A clinical trial that shows that a proposed treatment is not safe or not effective is just as valid as a trial that shows the opposite. If you submit to a clinical trial, you are agreeing to be part of a science experiment, and if you will forgive for my being blunt, pretty much at the level of a lab rat.
All science experiments must be designed before the experiment starts, so that the variables can be considered and controlled. Part of the reason that Dr. Burt should not alter the criteria for selection for any particular patient is that to do otherwise causes the loss of control over one or more of the variables. This loss could invalidate the trial.
Clinical trials are set up at different phases. Dr. Burt’s CIDP trial is a Phase I/Phase II, meaning that the efficacy and toxicity are being determined on a small group of people. The proposed treatment is thought to be safe and effective, but it has not been proven so. Under the normal standards of medical ethics, it would typically be considered unethical to prescribe the test treatment if other treatments are effective. This is the other part of the reason Dr. Burt has the selection criteria; he can only include those who have effectively no other recourse.
More of us could be included in a Phase III trial, but the Phase I/II trial must finish first and the results reviewed and approved. While we would all like to hurry the experiment along, you run the risk of ruining it if you do. Unfortunately for us, the experiment has a while to go. Dr. Burt’s study is not expected to finish before the end of 2014. The results then must be reviewed and approved. A Phase III trial will have to be organized. It would be unlikely to end before 2016 and given the risks of any bone marrow suppression, likely a year or two longer.
~MarkEns