Over the past year, CCSVI Clinic and its researchers and specialists have been studying the Combination venoplasty/autologous stem cell infusion protocol developed by Regenetek Cellular Technologies with the collaboration of outside labs and bioproducts manufacturers. As laboratory techniques gain ever-increasing sophistication based on new scientific methodologies for enhancing somatic cells into preferred lineages in vitro, the therapeutic outcomes for patients with neurological disorders have also been improving. Deb O’Connell who was treated at the Clinic in mid-September, 2012 recovered so quickly from her serious long-term degenerative disease condition that she experienced a wave of improvements while still in the hospital.
It’s a matter of medical record that Deb had been wheelchair bound for 10 years (completely non-ambulatory) with multiple co-morbidities when she entered the program on September 9; she was 9.5 on the EDSS scale as assessed by a neurologist, was down to 80 lbs in body weight, could not breathe effectively, speak, or take in food by mouth due to dysphagia. Her pain was chronic and significant. When she left the Clinic on September 24th , she walked out of the doors and into a waiting van to go to the airport. At the time of her discharge from the Clinic, she could breathe normally, effectively speak once again, eat any types of food she desired and her pain had all but disappeared. At the time of this writing she is back home in Canada and reports that she continues to recover (especially her contractured hands), shows no signs of new disease symptoms, and has gained 18 lbs since her therapies, less than 3 weeks ago. She has now begun a regular physiotherapy program and is gaining walking strength and balance. The recapitulation of the course of her disease (MS) within days, provides evidence that the in vitro requirement of cell pluripotency has correctly been identified with respect to adult cell source origin, time, and manipulation in culture.
The logic behind cell replacement therapy is that many or most neurodegenerative orders have a localized origin related to a specific area of the Central Nervous System. If treated selectively or super-selectively with the correct proportion of pluripotent cells using an effective protocol including method of delivery, and concentrations high enough to be considered clinical yet within the domain of safety, results would be clinically significant as in the case of Deb O’Connell.
This also seems to be the case in diseases such as MS, MSA, Parkinson’s disease and ALS among several others. In PD for example, strategies are aimed at dopaminergic cell replacement with implantation focused in the substantia nigra. In clinical trials there are some instances where these cells have survived for over 10 years, or the length of the study to date. While it is still too early to predict long-term outcomes for all of the MS patients who undergo the combination therapy protocol, there are results that can be used predicatively from a similar therapeutic study model that was established by Augusto Brazzini in his Clinical Study that followed Parkinson’s disease patients for a period of years. The Clinical Study, entitled “Intraarterial Autologous Implantation of Adult Stem Cells for Patients with Parkinson Disease”, has been ongoing since 2006. The study shows that neurological improvement in patients implanted with Mesenchymal Neuroprogenitor cells who recover 50-90% of their full function in the first 90 days begins to slow but progressively improves and maintains those improvements without the need for a second intervention. Furthermore, patients have seen clinical improvements only begin in a period from 3-9 months after first cell implantation.
For over a year other CCSVI Clinic patients have similarly benefited from the therapies, and each patient (who has not fallen outside of the inclusionary/exclusionary criteria either pre or post-operatively) is under case study at this time. We are aware of the value of long-term follow-up and that blind clinical trials have been the established method of determining both safety and efficacy. However where no model exists for the clinical study of cells unique to each patient, an adequate substitute would be a case-control approach. Although as in the case of testing for the efficacy of the ‘liberation therapy’ itself, this design has been much maligned, we believe that a rigorous case study can return measurable results in a more ethical design.
Deb O’Connell will be followed for the next 5 years in our study and updates will be made on her YouTube video through the informed consent process. For more information on the CCSVI Clinic Protocol you may contact the Clinic at info@ccsviclinic.ca, or call 888-468-1554.
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