Stem Cell Therapies

A new Phase I trial involving the use of stem cells in Multiple Sclerosis (MS) patients is underway in a study by the Cleveland Clinic, Case Western Reserve University, and University Hospitals Seidman Cancer Center. Multiple Sclerosis is an autoimmune disease, wherein the immune system attacks the central nervous system (CNS), both the brain and spinal cord.

So far, 2 patients have undergone the complete process, with another patient expecting to start the process soon. In all, 24 patients with relapsing or progressively worsening MS will be in the trial over the next 2 to 3 years. The protocol calls for harvesting of their own stem cells from bone marrow at the University Hospital, cultivating those cells at a Case Western laboratory, and then returning the stem cells to the patient intravenously at the Cleveland Clinic.

The primary focus of this study is to determine both the feasibility and the safety of such a treatment process. In the process, the researchers will also be looking for any evidence of improvement in the patients, although the trial is not set up to actually gauge either subjective or objective endpoints. This is a conservative study that will only look at safety parameters. If the trial goes well, further Phase II trials would likely follow, with actual treatment endpoints as the focus.

The first patient treated in the trial, Bill White, was first diagnosed with MS about 6 years ago. His first symptoms were fatigue and balance problems. After a while, exercise and even walking became problematic for him, and he eventually had to stop working. The reason for these issues is that in MS, the immune system abnormally attacks the CNS, leading to damage in the protective myelin sheaths, followed by irreversible damage to the axons and even neuronal death. The damage builds up and can progressively worsen over time, or can occur in a relapse and remission format. The process leads to noticeable changes on MRI and the diagnosis can be confirmed by looking at the spinal fluid. Mr. White had the characteristic changes on a scan of his brain in 2007. He has also since undergone treatment with 2 different drugs without seeing much benefit, if any, while subjecting him to a variety of side-effects.

After enrolling in this trial, his stem cells were harvested in March. The stem cells were cultured in the lab for months, and they were eventually injected into his bloodstream in June. Mr. White saw changes very quickly. He stated that "I used to have to use my left arm to lift my left leg up. Now I can lift it up on my own", meaning without the assistance of his arm. And although he still tires when walking, he does so less quickly now. In addition, his vision has improved from 20/50 to 20/20. Objectively, a recent MRI showed no new lesions in his brain. The proposed mechanism of action for the stem cells is in modulating the immune system, causing a decrease in the immune attack on the CNS. Also, the stem cells may be promoting the healing and regrowth of damaged tissues.

Other Phase I trials looking at stem cells and MS will soon be underway in Spain, China, and Iran. These are exciting times for sure, and the idea that a patient's own stem cells could help with the treatment of MS is truly amazing!

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Stem Cell Therapies