Stem cell/cellular interventions in human spinal cord injury: Is it time to move from guidelines to regulations and legislations? Literature review and Spinal Cord Society position statement

European spine journal

article

Harvinder S. Chhabra¹  Kanchan Sarda²  Geeta Jotwani³  M. Gourie-Devi⁴  Erkan Kaptanoglu⁵  Susan Charlifue⁶  S. L. Yadav⁷  B. Mohapatra¹  Abhishek Srivastava¹  Kedar Phadke¹ 

[1] Spine Unit, Indian Spinal Injuries Centre;Department of Basic Research, Indian Spinal Injuries Centre;Indian Council of Medical Research;Department of Neurology, Institute of Human Behaviour and Allied Sciences (IHBAS);Department of Neurosurgery, Marmara University;Craig Hospital;Department of Physical Medicine and Rehabilitation, All India Institute of Medical Sciences

关键词: Guidelines;    Spinal cord injury;    Acute paraplegia;    Clinical trial;    Stem cell;    Cellular interventions;    Position statement;    Regulations;   

DOI  :  10.1007/s00586-019-06003-3

来源: Springer

【 摘 要 】

In preclinical studies, many stem cell/cellular interventions demonstrated robust regeneration and/or repair in case of SCI and were considered a promising therapeutic candidate. However, data from clinical studies are not robust. Despite lack of substantial evidence for the efficacy of these interventions in spinal cord injury (SCI), many clinics around the world offer them as “therapy.” These “clinics” claim efficacy through patient testimonials and self-advertisement without any scientific evidence to validate their claims. Thus, SCS established a panel of experts to review published preclinical studies, clinical studies and current global guidelines/regulations on usage of cellular transplants and make recommendations for their clinical use. The literature review and draft position statement was compiled and circulated among the panel and relevant suggestions incorporated to reach consensus. This was discussed and finalized in an open forum during the SCS Annual Meeting, ISSICON. Preclinical evidence suggests safety and clinical potency of cellular interventions after SCI. However, evidence from clinical studies consisted of mostly case reports or uncontrolled case series/studies. Data from animal studies cannot be generalized to human SCI with regard to toxicity prediction after auto/allograft transplantation. Currently, cellular/stem cell transplantation for human SCI is experimental and needs to be tested through a valid clinical trial program. It is not ethical to provide unproven transplantation as therapy with commercial implications. To stop the malpractice of marketing such “unproven therapies” to a vulnerable population, it is crucial that all countries unite to form common, well-defined regulations/legislation on their use in SCI. These slides can be retrieved from Electronic Supplementary Material.

【 授权许可】

Unknown