Regulations and guidelines governing stem cell based products: Clinical considerations

Abstract

The use of stem cells as medicines is a promising and upcoming area of research as they may be able to help the body to regenerate damaged or lost tissue in a host of diseases like Parkinson′s, multiple sclerosis, heart disease, liver disease, spinal cord damage, cancer and many more. Translating basic stem cell research into routine therapies is a complex multi-step process which entails the challenge related to managing the expected therapeutic benefits with the potential risks while complying with the existing regulations and guidelines. While in the United States (US) and European Union (EU) regulations are in place, in India, we do not have a well-defined regulatory framework for “stem cell based products (SCBP)”. There are several areas that need to be addressed as it is quite different from that of pharmaceuticals. These range from establishing batch consistency, product stability to product safety and efficacy through pre-clinical, clinical studies and marketing authorization. This review summarizes the existing regulations/guidelines in US, EU, India, and the associated challenges in developing SCBP with emphasis on clinical aspects.

Stem Cell Therapy on the Internet: Information Quality and Content Analysis of English Language Web Pages Returned by Google

“…The aforementioned subclause is stated commonly by TCs and is considered to be legal authorization to treat with minimally manipulated SCs outside of a clinical trial protocol. In cases where TCs wish to offer treatments with cultured SCs, which have been expanded in the laboratory, the clause no longer applies, and the TC either has to operate according to approved clinical trial protocols (George, 2011), or to perform the procedure outside of the USA/European oversight. TCs around the world offer treatments for an array of conditions (Lau et al, 2008;Turner and Knoepfler, 2016), with variable levels of evidence, while the majority are not performing these therapies as part of a credible clinical trial (George, 2011).…”

Stem Cells, Dot-Com

“…Specif cally, DTC stem cell providers may claim that their products f t the def nition of "minimally manipulated" (processing that does not alter the relevant biological characteristics of cells or tissues) and are homologous [used to perform the same basic function (or functions) in the stem cell therapy recipient and donor]; these products may not be subject to FDA approval (14). Attempting to take advantage of this narrow def nition, companies such as Regenerative Sciences (www.centenoschultz.…”

The Potential Impact of Bone Tissue Engineering in the Clinic

“…These growth factors may also be useful in bone tissue engineering (Source: [48] The use of stem cells is strictly regulated by the FDA. In particular, the FDA requires that cells be "minimally manipulated, labeled, or advertised for homologous use only, and not combined with another drug or device" [35,36]. Without prior FDA approval, cells can only be used clinically if they are autologous, used on the same day of extraction, and are not manipulated by additional factors, drugs, or devices.…”