Combination Therapy protocol; Sequential 5-part protocol including true stem cells (autologous) $35,000 USD (includes everything below)
Please read this entire page to understand the distinct differences between the CCSVI Clinic therapy and any other clinical therapies available that performs cervical vein dilatation (Liberation Therapy) and/or stem cells and/or a combination of both. This protocol is an investigation into the combination treatment of both of the vasculature and central nervous system of an MS patient with adult autologous stem cells (cells taken from the patient). It is a novel, innovative ‘case study series’ entitled ‘Intravenous and Intrathecal Implantation of Adult Autologous Stem Cells for Patients with Multiple Sclerosis and Other Neurodegenerative Diseases’. Please note that this therapy is NOT medical tourism but an accredited IRB-approved clinical study through the Independent Ethics Committee Pune (IECP) and is registered with the Drugs Controller General India (DCGI). IRBs use a group process to review research protocols and all documentation related to the research (e.g., informed consent documents and investigator brochures) to ensure protection of the rights and welfare of human subjects of research. Prospective subjects who apply must qualify based on the criteria as determined by clinicians at Regenetek Research Canada. Please note that this research is only partially funded and subjects are contributing approximately half of the cost of their own studies. This is considered an ethical approach to medical research and approved by the World Medical Association (WMA). The balance of each patient’s case study is being funded by charitable private donations and our major Indian sponsors, Fidelity Life Sciences and Synapse Laboratories, India who we gratefully acknowledge. As of January 2014, the study has been reduced to 5 patients per month based on new budgetary constraints by the funders and we cannot accommodate more than that. We apologize in advance for the inability to meet the current demand and all inquiries are handled in order.
For more information please contact Regenetek Research Canada by leaving a message on this site or by calling the toll-free number on the Homepage.
Prospective patients may now join the official patient Facebook Group site, ‘Stem Cells for Neurodegenerative Diseases’ to communicate with many of the patients who have now had the Combination Therapy.
For the single price the patient receives:
- Informed Consent
- Examination of all patient medical records by medical team prior to departure
- Qualification through Regenetek Research
- CCSVI Clinic Travel Booklet
- Ground transportation to and from the hospital and the Airport
- Management team (physician and RN administrator) and access to Overseas Manager 24/7
- Minimum of 14 days in the hospital (private suite for 2 with Hospital bed; includes Internet, TV with English language programming, etc)
- All meals are catered on the ward; snacks are available on the ward 24/7. All cuisine is North American, unless the group decides they would like to sample some Indian cuisine (which they often do)
- Triage of patients first day to set up schedule (blood tests as required), and multiple other tests as necessary prior to procedure)
- Cervical vein dilatation if indicated, and first stem cell therapy,
- Venograms as indicated, pre- and post-procedure to identify all areas and extent of blockage
- Exceptional care by entire medical transplant team including Neurologist, Interventional Radiologist, Radiologist, Ultrastenographer, Hematologist, Vascular surgeon, Anesthetist, Cardiologist and Microbiologist, Physiotherapists, Nurses, Residents, various other specialties and admin (over 30 medical professionals on the team)
- Bone marrow aspiration for culture into appropriate stem cell type while in Cath-lab
- Infusion of stem cells (as indicated) both intravenously and intrathecally over period of days in hospital(based on culture and proliferation and differentiation of your stem cells- please see note on stem cell recommendations at the bottom of this page)
- Blood tests as necessary, measurements as necessary, CT, MRI, ECG, all as required
- Strict aftercare protocol for procedure (period of 72 hours post-procedure) to aid therapy and recovery (migration of cells to CNS)
- All medications as indicated by neuros and specialists
- consultation both pre and post-procedure by neurosurgeon to determine additional stem cell requirements (if any, but please note that additional stem cells, if needed must be cultured and will be an additional expense- see note at bottom of this page)
- monitoring after procedure (longer if medically necessary)
- All other expenses while in care, including additional costs due to complications if any (you will receive no further bill and as of Jan 1/2014 no additional costs for additional number of stem cells)
- All other follow-up care in the hospital at no additional expense
- Additional time in the hospital clinic if indicated at no additional expense
- Physiotherapy aftercare protocol (physiotherapist is extremely familiar with neurodeficits of patients) These will be exercise routines you can also take home with you.
- Full medical record of your procedure(s)
- Nurses and physicians are on the Ward 24/7
- Doppler Ultrasound screenings as indicated post-procedure period while in the hospital.
- Re-treatment in OR if there are any medical indications of pathology post-procedure (at no additional cost)
- Full medical file including copies of charts, screens, CDs of Venograms, blood work, EKGs, etc. for your records or family physician to review
- Consultation with Nurse-administrator upon return and coordination of post-procedure screenings at 3 and 6 months (if applicable), consultations with surgeons
- Consultation with surgeons after screening reviews upon returning home in post-period
- Follow-up web-based software for all patients to answer surveys at intervals, upload ancillary medical information, ask questions of any of the specialists involved in your care, and a chat feature to communicate with any other patients of CCSVI Clinic to compare notes and for support.
- Once procedures are over and patients are stable, our Overseas Manager will take group of whoever wants to go on shopping trips, day trips etc.
- PLEASE NOTE: Qualification for this therapy protocol is exclusionary based on EDSS scoring and other comorbidities. To further qualify, all patients should agree to be part of a case study through the IRB in keeping with the requirements of the Hospital System, the ICMR, and the ICMS (see below) to follow each patient in a case-based study. Long-term study information on a series of patients will serve to help everyone else with a similar disease condition. Caseworkers (generally academic post-graduates) will be appointed to follow all qualifying subjects. All qualifying patients understand that the cost of their therapy also funds, in part, their own case study and the larger investigation into the long-term efficacy of this therapy protocol as almost no funding exists for stem cell research from governments or drug companies, the traditional financial sources for such trial studies. As per the requirements of the ICMS, all patients must sign an Informed Consent.
- Patients exhibiting behavioral aberrance during their residency or any time afterward must be disqualified from the study by criteria addendum to the study as of Jan.1/2014 as determined by study researchers. These include changes encompassed by the new Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-5), American Psychiatric Association (APA), which has a number of changes to personality disorders.
- ALSO PLEASE NOTE that every effort will be made to assess your stem cell requirements before you leave, but this will be done at the hospital in any case. The total price listed above includes any number of stem cells required (100 x 106) whether above that basic clinical dose for the average patient or not.
- IN RESPONSE TO THE MOST ASKED PATIENT QUESTION: WHY A BONE MARROW SOURCE FOR STEM CELLS? The therapy protocol follows various recent trials (Harris, Sidiq, et al, 2012, Cambridge, Connick, et al, 2012) where marrow-derived stromal cells were expanded to clinical doses. In these clinical trials MSC cells from BM were found to have various properties (adhesion, etc) that were advantageous for in vitro development of MSC-NP cells. Various growth factors expressed by MSC-NPs, mediate effects on oligodendro-glial differentiation and are important in the recruitment phase of remyelination. In vivo, MSCs were associated with an increased number of endogenous neural progenitor stem cells. These observations suggest that MSC-NPs may influence the rate of axonal and tissue repair through trophic effects on host progenitors in the central nervous system (CNS). Furthermore, in these studies and from our own observations, the multiple trophic factors secreted by MSCs have demonstrated reduction in tissue injury, fibrosis inhibition, angiogenesis, chemoattraction, propagation of tissue stem cells, and a reduction of inflammation. These and other studies support the use of marrow-derived autologous MSCs in MS patients as a means of promoting CNS repair. By using this source it also then means that the disease has been ‘turned-off’, or deactivated. And if the disease process has been deactivated by the first infusion of MSCs, there would be nothing for an additional infusion of cells to react to. ADDITIONAL NEED FOR FURTHER INFUSIONS OF STEM CELLS are what we are specifically trying to avoid by appropriate characterization of the cells in the lab….the first time . Although difficult, time consuming and very costly, this is what is proving more efficacious than other techniques and sources of cells (ie: adipose). Getting this right is absolutely essential in this therapy because it very much depends on whether the properly characterized and isolated ‘true’ stem cells, that is telomerase-positive and CD90-positive + MHC-I positive cells have been infused. For these cells, the biological clock has not yet started as they are true stem cells. In clinical trials, they have been shown to have near-immortal characteristics, that is, they keep on differentiating, remyelinating and regenerating neuronal tissue for many years. Conversely, if the wrong cells, or simply a combination of all cells are selected for in vitro growth and infusion they have a much more limited time period of effective therapeutic value within the patient. Therefore cells need to be properly characterized BEFORE they are grown. In this respect CCSVI Clinic differs significantly from other clinics (most of which use an adipose tissue source because of cost and convenience). Patients who have had the adipose-derived stem cell lineage at other clinics have confirmed that they must have follow-up infusions. So far, there has been no need for this in the CCSVI Clinic protocol as the stem cells infused over the past 18 months (as of March 2013) are still judged to be active in all of the patients that researchers from Regenetek are following.
Everyone at the Clinic speaks English, and English is also the medical language at the Clinic so there is no language problem with North American patients. Again, safety is the primary concern of all therapy and no patient will be released from the hospital if it is not medically safe to do so based on daily monitoring of all signs by the medical team post-treatment.
Please note that special provisions may not be able to be accommodated for extraordinary dietary requests based on availability of supply, although these might be perfectly reasonable requests in North America.
Again, please note that patient/subjects and their companions are admitted to the clinic’s own wing within the hospital for the patient’s specific medical therapy. Hospital rules must be strictly followed. Accordingly, the 14 or more days in residence is for the strict purpose of undergoing medical treatment and should not be viewed as a ‘vacation’ for the purposes of recreation. We ask that special personal requests by either the patient or companion be put aside in favour of the medical procedures however difficult it is to sacrifice those personal needs for the length of your stay in residence. Alcohol, even for meals is not allowed in the hospital.
If timing is important in your planning, we recommend you get your procedure scheduled now. Available dates are always in demand and it will take a few weeks to get your Medical Visa. Your deposit secures your position, and if for any reason you do not qualify or cannot travel, it is refundable less admin charges and subject to the scheduling of your procedure. All deposits are immediately forwarded to the hospital and will be refunded based on reasonable time for their medical administration to do so. There is no financial risk to booking early.
In proceeding with our application for the ICMS, we have also adopted the philosophy and strict guidelines of the International Cellular Medicine Society (ICMS) and it is our view that all current therapies meet these requirements as of March, 2012:
Basic Tenets of Cell Based Medicine
- The ICMS supports legitimate medical innovation outside of the context of a formal clinical trial.
- The ICMS defines legitimate medical innovation as the clinical application of innovative therapy that is based upon good patient care, is intended to improve or ameliorate an individual patient’s condition and evidences a reasonable chance of success for the patient being treated.
- The use of autologous, adult stem cells is the practice of medicine and, as such, is subject to the laws and regulations that cover the practice of medicine.
- An informed patient has the right to access innovative therapies and that ethical physicians must be trusted to use their professional judgment and experience in determining a treatment regimen for his or her patient.
- Cell based medicine is a new and innovative field and, as such, requires specific, unique and global mechanisms for scientific transparency, medical oversight and patient protections.
- The procurement of cells from patients must be conducted using sterile techniques and universal precautions to minimize the risks of contamination and infection.
- The level of oversight should be proportional to the degree of risk associated with the treatment.
- Every patient should be monitored for long-term health effects.
- Every treatment protocol needs to include a clear, timely and effective plan for adverse event reporting.
- All treatments utilizing stem cells must be subject to on-going review and evaluation by an independent oversight body.
- Any medical or scientific claim must be based on accepted and acknowledged scientific evidence and medical experience.
- Governments should develop, in association with the ICMS or other oversight organizations, a set of standards and guidelines to evaluate the practice of stem cell medicine at the national, regional or local level.