The below is extracted from a 2011 NIH publication written by Bobby George. Since the publication, a lot has happened with respect to implementing what is needed in order to allow a more harmonious process for those applying for IND approval. As stated, though, this is still considered very new. However, stem cell treatment is a very fast moving market and those who had little or no interest in as little as five years ago, certainly do now.
It should be noted, too, that from all that I have gathered, Regen has complied with all of the requirements and has proved that all measures required to carry out the trials from point A to point B are respected and covered.
And though a lot has changed in terms of regulatory approaches and considerations (and will continue to change no less since this is evolving at such a fast pace) the below listed data on the origin of the cells pretty much are the same.
As I have stated a number of times, we do not know when the FDA will return their decision. It can be anytime. It will be sooner than later I am pretty sure though. Contrary to what some might insist.
-------Stem cells have a unique ability to differentiate into the specific cells required for repairing damaged or defective tissues or cells. Stem cell based therapies, encompassing collection, purification, manipulation, characterization delivery of cells for therapeutic purposes, have existed since the first successful bone marrow transplantation in 1968.
Presently, human embryonic stem cells (hESCs) are used in 13% of cell therapy procedures, while fetal stem cells are used in 2%, umbilical cord stem cells in 10%, and adult stem cells in majority (75%) of treatments.
There is still a significant gap between promising laboratory-based research and approved SCBPs (stem cell based products) in this fast emerging field. Legislation in this field must seek to both regulate and enable scientific progress without being confusing, difficult to interpret or unnecessarily onerous. In addition, the public must have confidence that its interests are protected. Few of the measures which could help to speed up the translation of SCBP from bench to bedside while still ensuring patient safety include the following.
In the U.S., classification of stem cell based therapies is based on indication to be treated. Restrictions are limited to research with federal funds. No limitations exist for research with hESCs, provided the funds come from private investors or specific states.
The FDA has developed a regulatory framework that controls both cell- and tissue-based products, based on three general areas:
Prevention of use of contaminated tissues or cells (e.g. AIDS or hepatitis);
Prevention of inadequate handling or processing that may damage or contaminate those tissues or cells;
Clinical safety of all tissues or cells that may be processed, used for functions other than normal functions, combined with components other than tissues, or used for metabolic purposes.
Manipulated autologous cells for structural use meet the definition of somatic cell therapy products and require an “investigational new drug” (IND) exemption or the FDA license approval. In 2007, the “Guidance for Industry: Regulation of HCT/Ps – Small Entity Compliance Guide” and in 2009, the “Guidance for Industry on Current Good Tissue Practice (cGTP) and Additional Requirements for Manufacturers of HCT/Ps” had been released. Clinical studies employing mescenchymal stem cells (MSCs) underlie the IND mechanism. Accordingly, the investigators have to make an IND application, which necessitates detailed study protocols describing the clinical plan as well as the preparation and testing of the therapeutic cell product.
--Compliance with the existing regulations and guidelines to ensure that the product is safe, pure, and potent meeting GTP, GMP and GCP requirements.
--Nonclinical evidence on the proof-of-principle and safety in a relevant animal model should be tried before administration to humans.
--Encourage companies to develop and validate new non-invasive methods for biodistribution studies in humans to follow the cells during the CTs. Possible markers/tracers should be evaluated and justified.
--A risk-based approach to be applied while giving regulatory approvals. Conditional marketing authorization could be a possible approach without compromising on patient safety.
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