Action taken by CDSCO against misuse and unethical stem cell clinical trial malpractices at hospital

  • Posted on: 16 December 2014
  • By: PharmaTutor News

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Central Drugs Standard Control Organization (CDSCO) investigated a Pune based hospital after receiving compliant against hospital that they are performing unethical stem cell clinical trial and patients are highly charged for unapproved and illegal transplants.

CDSCO stated that a complaint was received against Chaitanya hospital to investigate the misuse and unethical stem cell clinical trial malpractices. Various stem cell treatments with high treatment costs such as Cerebral Palsy, Stroke, Wilson’s disease and Spinal Cord injury are being offered at hospital. It was also mentioned in the complaint that the patients are highly charged for unapproved and illegal transplants.

Taking cognizance of the complaint, an investigation was undertaken by CDSCO officials at the hospital. The investigation team in its report had observed that the hospital had not obtained permission from CDSCO for the clinical trials.

Further investigation observed that the patients with bone marrow derived stem cells for various diseases like Cerebral palsy, Autism, Vascular necrosis, Spinal Cord injury, Diabetes Mellitus, Hemiplegia etc. were treated in hospital. The processing of bone marrow derived mono nuclear cells was claimed to be fall under minimum manipulation category as per ICMR guidelines but in the hospital there was no instrument or equipment provided which ensures aseptic processing and no documents were maintained as required under Good Clinical Practices and moreover patients were charged heavily for the treatment for period 2013 to Sep 2014.

CDSCO notify them to stop the treatments with stem cell products to the patients in the name of clinical trial with immediate effect till further orders.

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