At the recent FDA meeting last month, scientists, physicians and lay people with severe chronic diseases all had a chance to tell their stories and offer opinions to the agency about the use of “stem cell therapy”. When a person with MS or Parkinson’s alleges or reports a benefit, it is often hard to separate the science from natural ups and downs of the disease. When a for profit company makes a claim, it is often hard to separate out the obvious conflict of interest from a real potential game-changer. Very few at the meeting were there to report negative results; although one doctor from Miami showed 3 cases of patients who had lost their vision from “stem cell” injections given for macular degeneration. ALso, there was one report, from abroad, of embryonic cells causing a spinal tumor.
The FDA is in a tough position; the dictum of physicians is primum non nocere; this above all do no harm. On the other hand, there is obviously potential for disease modification or cure, if we could just figure it out.
Some patients strongly feel that if the cells come from their own bodies, it is nobody’s business who does what to whom…this would be a libertarian approach. The problem is, if this turns out to be a total flim flam, or worse, doesn’t the FDA have a responsibility to intercede?
The most pressing observation is this: many of the clinics are harvesting not stem cells but patient’s money. They are good at the latter but not the former. Stem cell therapy should begin with the VALIDATION (by 3 biomarkers) that we are, in fact, working with stem cells and not just fat, or blood, or a dose so small (of cells) as to be irrelevant. Second, we are far more likely to get good data from a not-for-profit entity (like the NIH). Third, we should widely circulate information, as in this blog, that helps patients make good decisions (and saves them money). These principles would protect the public to a large degree and would not hinder advancement of this very important field.
On Sept 12 Dr. Marcus is to present at the FDA conference on Cells and Tissues that will help determine the new guidelines on the use of stem cells and growth factors.
This fall semester, Dr. Marcus will once again teach “Funding a New Venture” through the Advanced Acadmeic Programs Department of Johns Hopkins. This is an online course with worldwide participation.
So far the first 11 patients with “amniotic” injections are doing fine, no complications and 10/11 experiencing little if any symptoms; in other words, PRP plus the amniotic fluid appears to be as good as PRP alone. It is still too early to determine if the addition of the amniotic fluid is better than PRP alone. Since this is not a controlled, blinded study, we will have to use prior knowledge and expectations to make a judgement of this kind.
As to the fluid, it contains a variable number of cells that appear in the cell counter as either lymphocytes or granulocytes. As expected, quality control of cell number is problematic and is not being done at the tissue bank on each lot. We are in the process of analyzing the growth factors in the fluid, which of course may be equally or more important than the cells. Stay tuned.
Dr. Marcus to teach E & E at George Mason University this Spring Semester 2016.
On Fri Nov 13 Dr. Marcus spoke to the entrepreneurs at Johns Hopkins Medical School about concepts in funding new ventures. The Group is Called Hexcite!
We now have access to a source of stem cells derived from healthy deliveries (C sections) and screened thoroughly by an accredited tissue bank. These are allograft cells, meaning, from a different person, and do not require tissue matching because they do not possess immunogenic surface antigens. The cells arrive frozen in dry ice, and must be used on the day of arrival. The present plan is to combine the cells with the growth factors of PRP. The cost of these cells is moderate, especially compared with charges for bone marrow aspirate that are offered in other centers.
Please inquire if this exciting new addition to our technology is of interest to you.
Dr. Marcus will be in Stuart Florida to talk about Surface and Sub-surface reconstruction of the damaged joint.
April 5, Waterview Conference Center
Topic: Juvenile Allograft for Cartilage Reconstruction
Dr. Marcus is to speak on the role of PRP and Cartilage Repair at the forthcoming Sanibel Perfusion Symposium, Ft. Myers Fla.
Feb 15, 2014.