- Q?Clinical trials involving human subjects require Institutional Review Board approval, otherwise known as an IRB. Does Regenetek Research have IRBs and through which accredited institution or institutions?
Yes we do. An Institutional Review Board is a committee designated by an institution to review, approve the commencement of, and conduct intermittent review of research involving human subjects. All Human Subjects Research must receive approval from an Institutional Review Board (IRB). The study in question is entitled: ‘Intravenous and Intrathecal Implantation of Adult Autologous Stem Cells for Patients with Multiple Sclerosis and other Neurodegenerative Diseases’ and is a Case Study series. All of our research meets the definitions of both ‘research’ and ‘human subjects’ and a rigorous IRB approval and accreditation process was followed. The governing authority is the Drugs Controller General and Licensing Authority, India (DCGI). The Independent Ethics Committee has been assigned the number: ECR/14/indt/MH under Rule 122DD of the Drugs and Cosmetics Rules 1945 and the IRB has been granted to the Independent Ethics Committee Pune, Approval number IECP/27/2011. The ethical principles described in the Declaration of Helsinki provide the foundation to ethically allow this research. The Indian research conducted at CCSVI Clinic located in Inamdar Hospital in Pune India. Regenetek Research follows all minimum guidelines of the International Cellular Medicine Society and conforms to the research protocol whereby the therapy described is considered the practice of medicine, and/or is within the legal and regulatory statutes of the country where the treatment is provided, and approved by the appropriate agencies.
- Q?Is Informed Consent required for all patients?
Yes. Informed Consent is a process of communication between a prospective subject and clinician that results in the subject’s agreement to undergo a specific medical intervention. In the communications process, the appropriate clinician or researcher will discuss:
- The patient’s diagnosis
- The purpose of the proposed therapy
- The risks and benefits of the proposed therapy
- Interventional alternatives
- The risks and benefits of the alternative treatment or procedure; and
- The risks and benefits of not receiving or undergoing this or any other treatment or procedure.
The prospective subject will have the opportunity to ask questions in order to better understand the therapy so that he or she can make an ‘informed decision’ whether or not to proceed or refuse the medical intervention offered.
- Q?Various oversight organizations have only approved autologous, or the patient’s own stem cells for therapy. Are you observing the rules about only using cells that are taken from the patients themselves?
Yes. Only autologous blood stem cells are collected. Subjects who proceed to transplant will undergo a routine procedure for the collection of stem cells from bone marrow. This is well-described in the protocol and the Informed Consent.
- Q?What type of cells does your therapy use for treatment?
There are multiple adult stem cell types present in adult tissues. These adult stem cells range from the most differentiated cell types (functioning parenchyma and stroma) to the least differentiated cell type (totipotent stem cells). Each cell type within this group has its own unique attributes and cell culture requirements.
- Differentiated Cells (DCs)
- Progenitor Cells (PCs)
- Germ Layer Lineage Stem Cells (GLSCs)
- Pluripotent Stem Cells (PSCs)
- Totipotent Stem Cells (TSCs)
A cell can be classified as a differentiated cell (DC) (i.e., parenchyma or stroma) if it is derived from a single cell, has a lifespan limited to less than 50 population doublings, and is a functioning portion of the tissue. A cell can be classified as a progenitor cell (PC) if it is derived from a single cell, it has a defined biological clock of 50-70 population doublings, and is the immediate precursor for adult differentiated cell types. A cell can be classified as a germ layer lineage stem cell (GLSC) if it is derived from a single cell, it has unlimited proliferation potential and forms all cell types within a single germ layer lineage, i.e., ectoderm, mesoderm, and endoderm. GLSCs are also known as multipotent stem cells. A cell can be classified as a pluripotent stem cell (PSC) if it is derived from a single cell, it has unlimited proliferation potential, it can form multiple cell types from all three germ layer lineages, but cannot produce gametes (sperm or ova) or placenta cells. A cell can be classified as a totipotent stem cell (TSC) if it is derived from a single cell, it has unlimited proliferation potential, it can form multiple cell types from all three germ layer lineages, and it can produce gametes (sperm & ova) and placental cells.
The method described in the protocol uses a sub-population of pluripotent Mesenchymal stem cells (aspirated from the bone marrow) that are colonized in vitro once processed. The technology is proprietary, and is performed at Reliance Labs under the terms of an Agreement. All cells are produced under cGMP conditions.
- Q?Are there hospitals closer than India where I can be treated as part of your trial?
Great question. Not at the moment. We are attempting to recruit some clinics that are closer to North America but there are a couple of problems with this. Firstly, this therapy is expensive, as you can imagine. For the price the clinic would have to charge a patient, there wouldn’t be many patients able to afford it. What the patient pays is already subsidized by a large clinical trial company. Secondly, the technical sophistication of the lab must be replicated anywhere this therapy would be done. We are currently using one of the largest and most sophisticated labs in the world at Reliance, with the most competent, experienced and educated pathologists and microbiologists to perform the function of characterizing certain cells from the sample and colonizing them to clinical populations. It’s doubtful that many other labs anywhere in the world could accomplish this at all, much less through the time-defined residency of the patient over the period. However, we are working on it and hopefully there will be at least one more clinic offering the Combination Therapy protocol within a year.
- Q?How do you follow patients in your trial when they are treated in one country, but live half-way around the world in another country?
The unique ‘patient-following’ software was developed by Regenetek Research because there is a high need for a study design that provides proof of both safety and efficacy for new treatment interventions such as stem cell therapy where autologous stem cells are used. In this case it would not be appropriate to treat a second patient with the first patient’s cells and therefore the Randomized Controlled Trial (RTC) design preferred by the FDA is not appropriate. All patients in the study receive their own ‘dashboard’ on a personal password-secure site. From wherever they are in the world post-therapy, patients can login to their dashboard to answer survey questions. The survey questions are specific to their disease. Over time intervals such as every 3 months for 5 years, this series of surveys becomes data for the study. Depending on the outcome being followed prospectively, each study is customizable and both researchers and patients have unique views and functionality through a dedicated, secure web-based site (all data are encrypted and conform to HIPAA/EDI compliance standards). For researchers, the electronic Case Report Forms (eCFRs) can be loaded as per IRB at the outset. The software automatically tracks patient results and even allows the patient to upload ancillary medical records, such as MRIs. There are various other unique features: the system tracks patient locations if they move, automatically sends out reminder emails or text messages to patients, automatically applies bias reduction models, automatically searches and tracks other interventional therapies for the same disease type and creates cohort comparisons in template charts, applies standardized disability scales to diseases to create surveys, aggregates patient populations from different centers, automatically populates study data in charts and within templated study design formats for easy publishing, and has a feature to allow direct communication with the principle investigator (PI) to report adverse events (AEs). Features can be turned on or off as required by the study design. The software is even available as an i-phone app.