Unproven Stem Cell Therapies in India: Regulatory Challenges and Proposed Paths Forward

Tiwari, Shashank S.; Desai, Pranav N.

doi:10.1016/j.stem.2018.10.007

Cited by 22 publications

(5 citation statements)

References 6 publications

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“…This misuse is mainly due to a huge gap in regulations and a lack of policies. However, The Indian Council of Medical Research (ICMR) has raised a voice to place “stem cells” into drugs [ 60 ].…”

Section: Cancer Immunotherapeutic Productsmentioning

confidence: 99%

Innovation in cancer therapeutics and regulatory perspectives

et al. 2022

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Cancer therapy has undergone a drastic revolution in the past few decades with the introduction of several novel therapies, like immunotherapy (active and passive), stem cell-based therapies, and nanocarrier-based therapies. These therapies have addressed the issues of conventional cancer therapy (chemotherapy or radiotherapy), like specificity and off-target effects. Further, the introduction of such treatments has improved survival and converted a terminal disease into a more manageable condition. However, many clinical, ethical, and regulatory issues are raised with such novel additions. Several effective therapies are under research but could not come to market or are delayed due to regulatory concerns for marketing approval. The scope of this review encompasses the examination of these regulatory issues and discuss their possible solutions. A practical and flexible regulatory approach, harmonized globally, could help the patients suffering from a terminal illness to lead a quality life.

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Section: Cancer Immunotherapeutic Productsmentioning

confidence: 99%

Innovation in cancer therapeutics and regulatory perspectives

et al. 2022

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“…147 Even so, uncontrolled, unproven stem cell therapies proliferate across the world leading to disastrous outcomes. [148][149][150][151] Greater vigilance by physicians 152 and by regulatory agencies is needed to avoid curbing the development of ATMPs.…”

Section: Current Use Of Ad-mscs In Medicinementioning

confidence: 99%

Adipose-Derived Mesenchymal Stromal Cells in Regenerative Medicine: State of Play, Current Clinical Trials, and Future Prospects

Laloze

Fiévet

Desmoulière

2021

Advances in Wound Care

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Significance: Wound healing is a complex process involving pain and inflammation, where innervation plays a central role. Managing wound healing and pain remains an important issue, especially in pathologies such as excessive scarring (often leading to fibrosis) or deficient healing, leading to chronic wounds. Recent Advances: Advances in therapies using mesenchymal stromal cells offer new insights for treating indications that previously lacked options. Adiposederived mesenchymal stromal cells (AD-MSCs) are now being used to a much greater extent in clinical trials for regenerative medicine. However, to be really valid, these randomized trials must imperatively follow strict guidelines such as consolidated standards of reporting trials (CONSORT) statement. Indeed, AD-MSCs, because of their paracrine activities and multipotency, have potential to cure degenerative and/or inflammatory diseases. Combined with their relatively easy access (from adipose tissue) and proliferation capacity, AD-MSCs represent an excellent candidate for allogeneic treatments. Critical Issues: The success of AD-MSC therapy may depend on the robustness of the biological functions of AD-MSCs, which requires controlling source heterogeneity and production processes, and development of biomarkers that predict desired responses. Several studies have investigated the effect of AD-MSCs on innervation, wound repair, or pain management separately, but systematic evaluation of how those effects could be combined is lacking. Future Directions: Future studies that explore how AD-MSC therapy can be used to treat difficult-to-heal wounds, underlining the need to thoroughly characterize the cells used, and standardization of preparation processes are needed. Finally, how this a priori easy-to-use cell therapy treatment fits into clinical management of pain, improvement of tissue healing, and patient quality of life, all need to be explored.

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“…The most likely mechanism of action should be investigated during the pre-clinical stage; this will allow the design of an adequate potency test that ensures the functionality of the NSC product in the clinical phases [ 148 ]. Ensuring cell product potency and producing bona fide cell therapy products is key, especially considering the emergence of multiple producers offering fraudulent therapies based on scientifically un-sustained claims [ 149 , 150 ].…”

Section: Clinical Grade Nsc Therapies: Safety Efficacy Scalability and Quality Control Considerationsmentioning

confidence: 99%

Human Neural Stem Cells for Cell-Based Medicinal Products

Fernández‐Muñoz

García-Delgado

Arribas-Arribas

et al. 2021

Cells

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Neural stem cells represent an attractive tool for the development of regenerative therapies and are being tested in clinical trials for several neurological disorders. Human neural stem cells can be isolated from the central nervous system or can be derived in vitro from pluripotent stem cells. Embryonic sources are ethically controversial and other sources are less well characterized and/or inefficient. Recently, isolation of NSC from the cerebrospinal fluid of patients with spina bifida and with intracerebroventricular hemorrhage has been reported. Direct reprogramming may become another alternative if genetic and phenotypic stability of the reprogrammed cells is ensured. Here, we discuss the advantages and disadvantages of available sources of neural stem cells for the production of cell-based therapies for clinical applications. We review available safety and efficacy clinical data and discuss scalability and quality control considerations for manufacturing clinical grade cell products for successful clinical application.

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Unproven Stem Cell Therapies in India: Regulatory Challenges and Proposed Paths Forward

Cited by 22 publications

References 6 publications

Innovation in cancer therapeutics and regulatory perspectives

Innovation in cancer therapeutics and regulatory perspectives

Adipose-Derived Mesenchymal Stromal Cells in Regenerative Medicine: State of Play, Current Clinical Trials, and Future Prospects

Human Neural Stem Cells for Cell-Based Medicinal Products

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