What is a Stem Cell?—This is a basic cell before it becomes a particular cell used for one body function or body part. The stem cells used in this study are the cells from your own adipose (fat) tissue.
What’s the goal of the study?—This is a Phase I study, which always has a goal of providing evidence that the procedure is safe. The second goal of the study is to collect and analyze data on symptomatic improvement or efficacy .
How is this study different from other “Stem Cell Treatments?”
The main difference, besides the use of each person’s own stem cells (which means that no chemotherapy is required, ie, easier on the body)—is that this is not a “Same Day” procedure. (This is explained below.)
“Same Day” Procedures—Right now there are a number of clinics offering same day stem cell treatments utilizing “stem cells” that are harvested, processed and infused into the patient the same day. This type of processing of the fat tissue results in a product called stromal vascular fraction (SVF). SVF includes approximately 40 different cell types and in this type of treatment it is difficult to identify how many of each type of cell is in the treatment sample and what cells in the SVF are actually providing the benefit.
How this testing and data collection differs from “Same Dayi” Procedures and studies--
In same day procedures the cells are collected and infused in a matter of hours. While some studies are performing cell counts, these generally are counting all the cells in the SVF, published literature estimate that only 2% to 10% of the cell counted are stem cells. Considering the timeframe, full FDA 14 day sterility tests cannot be completed prior to infusion and cell identity confirmation is very limited if performed at all in a same day procedure.
Does Stem Cell therapy work?—So far, early scientific publications and studies say yes. In 3 ways the transplanting of stem cells into a body of a person with MS works.
1. Protects (targets neurodegenerative component)
2. Repairs myelin
3. Targets autoimmune inflammatory component, regulates the immune function
What does that mean in terms of our individual cases of MS?—The goal of the study is to confirm the safety of the treatment, the secondary goal is to collect data regarding the reversal of symptoms and slowing or stopping the progression of the disease. That’s what it means in terms of our individual cases of MS.
Does it only work where the cells are re inserted? The stem cells are introduced to the participant through an infusion process allowing the infused cells to travel all over the body to reach the affected area and to heal at that place. The studies that I read about explain that the cells travel to the place that is affected. How, I don’t know, but it sounds like it just is drawn to the place where it is needed.
How long does it work?—This isn’t known. Some studies report that 3 years later the therapy still is having good results. It could, in reality, last 3 months, 3 years, a lifetime. But this isn’t known.
Where do the stem cells come from?—The participant’s own adipose stem cells are used in this study. They are fatty cells. This is one form of cell that works well in stem cell therapy. The cells are collected by a cosmetic or plastic surgeon in a mini liposuction and delivered to the laboratory for processing, culturing, testing and packaging.
How are the cells in this study tested?
(This is information that I got from the sponsors, and it is impressive but hard to follow!) The processing facility that creates the stem cell treatment samples employs a rigorous testing regimen including multiple full 14 day sterility growth analysis as is required by FDA GMP regulations for clinical grade human usable products. Additionally, the facility will tests the viability and growth rate of the cell sample during processing and quantify the number of cells cultured and prepared for the treatment. Finally the facility employs third party qualified private and university laboratories to confirm the cell identity and secondary disease and sterility testing of the prepared samples.
What information is collected about the cell sample and how is it stored? In addition to the in-process testing and analysis, the company keeps a complete record, called a batch record, that contains all the materials, disposables, equipment, technicians, supervision and quantitative information about the sample, the total number of cells created, and the processing. Additionally, the company isolates a portion of the sample for long term quality management analysis and testing in case there are any future questions or requests for information by the participant’s physician or by any regulatory agency. These records will be kept for a minimum of 10 years following the treatment. The created samples are cryogenically stored in a vapor liquid nitrogen tank at -190⁰ Celsius.
What kind of follow-up is done? For participants there are follow-up reports provided by account of 3-month vital (blood pressure, temperature, heart rate) information; 3 month, 6 month and annual reports by doctor, using MS questionnaires and logged into HIPPA-compliant database.
Who is eligible?—age 18-65. Diagnosis of MS (provide letter from doctor).
How can I find out more/sign up?—Call American CryoStem at (732) 747-1007 and get the application and information packet. Get a letter from your doctor describing what sort of MS you have (this will not be used to screen participants from the study, but will be used as information for this and future studies).
Then what happens?—They will send you a packet, you will fill out the application and supply the requested information and fax, mail, or email it back.
The packet includes a list of 18 articles referenced in the original Study Protocol. I have downloaded articles (and when I wasn’t able to download articles I downloaded abstracts). If you want a copy of what I have (over 230 pp!) either friend me on face book (Rosalie Richards) and send a private message, or email me, and I will send the articles via attachment.
This letter isn’t an attempt to sell you on this, but if this is something you want to know about, I want you to have this information.