At the request of many people who have contacted me directly, I’ve reprinted this from a reply on David Summers’ blog with a few additional pieces of information on the ICMS. I will expand upon this shortly with a series of excerpts from a study article co-authored by me and several other clinicians for major publication later this year. This article was written in response to several people who doubted that a combination of therapies that included stem cells could account for the positive changes that David Summers is currently enjoying after his therapy at CCSVI Clinic.
Actually, understanding what has been clinically proven over the past 2 years, David Summers is now seeing the same beneficial results as had been recorded in several clinical trials that have not taken the therapies to quite the same level of treatment as where David received his therapy (CCSVI Clinic, Pune India). Just from our perspective here in the US, David in his really detailed account has described the exact protocol that is going on in the MS trials at the Cleveland Clinic/Case Western Reserve University School of Medicine as well as the trial at the Multiple Sclerosis Research Center of New York being run by Dr. Saud Sidiq in association with the International Cellular Medicine Society (ICMS).
The adult autologous Mesenchymal Stem cells (MSC-NPs) that David received are known for their properties of immunomodulation, anti-apoptosis, angiogenesis, anti-scarring, homing through chemoattraction and support of growth and differentiation of stem and progenitor cells. These characteristics have all been well documented in 4 main studies, namely the 2007 Iranian study (Mohyeddin), the 2010 Lebanese study (Yamout), the 2010 Israeli Study (Karussis) and the Cambridge study just published this year 2012 (Connick). Each of these studies found efficacy of therapy in every area of functional deficit David is reporting improvement. So medically speaking, it would not be likely to see results other than the ones that David is reporting observationally unless the clinic where he received his therapies wasn't doing it correctly or wasn't basing their therapies on the current research, which they seem to be. Furthermore the timelines he is observing in his recovery of functions are more or less the accelerated timelines consistent with the trial documentation.
In the few short weeks since he contributed his blog to the CCSVI Locator site on May 22, 2012, it is my understanding that as of this writing, David has been able to take anywhere from 10 to 30 steps at a time with and sometimes without the assistance of holding onto a hand rail or a walker assist. This being the case, his motor nerves and balance are coming back in the critical 60-120 day period where the studies predict the largest increases in motor nerve recovery due to stem cell replacement of neurons will occur. The Cleveland Clinic results are well described here: http://www.youtube.com/watch?feature=player_embedded&v=0aE2fYP-0uk. I urge everyone to watch this video. To any skeptics out there this should provide some answers.
The extent to which David improves is now the question, but it's significant that he has shown these functional neurological deficit recoveries after just a few months. In less than 90 days he has moved from a wheelchair where he spent the last 10 years (EDSS 8.0) without any sensation whatsoever below the waist to being able to ambulate a fairly good distance, and is increasing that capacity on a daily basis. Also of significance, all of the presenting symptoms of MS have diminished or disappeared altogether and both full control of his bladder, and his sexual functions have returned (to normal). He reports significant strength returning to his limbs, especially his legs even on days he is not able to exercise.
David also tells me that he will soon post his improvement videos on YouTube. And while we all wait to see this video evidence, there are now scores of other patients being treated in ICMS certified clinics, receiving stem cell therapies under protocols approved by the ICMS for a variety of neurological diseases including Parkinson’s, ALS, MSA and Cerebral Palsy to name a few. Unfortunately, It’s not a surprise that stem cell research for MS in the US is not financially supported by the drug companies, but is being done in these clinics located in other countries where some funding is available and where patients self-select to both obtain and fund the therapy and their own trial data. Through the ICMS, their clinical data is then prospectively entered into case studies and aggregated for later publication. No ICMS-certified clinics can treat any patient that isn’t entered into a case study.
Case study evidence aggregated from these clinical trials is really the key to moving medical progress along for MS and other neurodegenerative diseases through stem cell therapies. Although almost unknown to most researchers outside of the ICMS circle, the progress in these clinics in medical research into stem cells over the past 2 years has been nothing short of remarkable. Although relatively small, collectively these hospitals and clinics are really the driving force behind the successful stem cell research going on globally. Since none of these clinics are receiving any major funding from drug companies or other major sources (with a few exceptions), the evidence will not conform to the rigor of double blinded, randomized control trials. But to do so would also push the boundaries of ethics in developing a trial where hopeful subjects would expect to receive treatment for a neurodegenerative condition that will eventually lead to their deaths, but receive a placebo instead (this is the same ethical dilemma being experienced for the protocol designers of the upcoming ‘liberation therapy’ trials). The ICMS is currently working toward evaluations of studies where the data analysis approach will be as alternatively comprehensive.
The translation of the current research on stem cells in these clinics is extremely important. The case reports coming out of CCSVI Clinic in Pune India (the only clinic performing the combination protocol for MS), the Brazzini Institute of Interventional Radiology in Lima Peru, Stematix (Houston/Buenos Aires), World Stem Cells, Cancun, MX, and the Stem Cell Institute in Panama, (and some others) are going to be crucial to the process of providing long-term evidence of safety and efficacy that adds to all other research going on in the US. Each of these organizations also presented their research to the recent stem cell conference in Florida hosted by the International Cellular Medicine Institute.
http://www.cellmedicinesociety.org/conference
About the ICMS
Stem cell research is one of the fastest growing areas of medical science today. Masses of clinical data derived through studies are currently being produced outside of approved ICMS guidelines, where patients and practitioners are ignorant of standards and record-keeping methodologies. Apart from safety and ethics issues, without a common aggregator, there would be no way to accurately estimate of how many patients have been treated therapeutically, as well as the results of those treatments. Strategies developed by the ICMS to share data amongst well-organized clinical trials will move single accounts like David’s from anecdotal evidence derived from one clinic to be aggregated alongside charted data from clinical case studies from other clinics to establish trends in data and larger samples that actually work. Good clinical data will be the key evaluator of the worth of any given therapy protocols. The ICMS has developed a set of Guidelines and Standards for clinical and laboratory aspects, as well as the patient follow-up Registry. To date it has been run independently by the ICMS as the global facility accreditation service (as well as an adverse events/complaints monitoring service).
In fact the science is much further along than anyone realizes and I would urge everyone reading this to support or professionally join the ICMS to advance the research into stem cell therapies. MS patients will be among the first to benefit.
www.cellmedicinesociety.org