Skip to main content

Controversial Experiment for Brain-Dead Revival Dropped

A controversial experiment to revive brain-dead accident victims has been scrapped.

​​


The Indian Council of Medical Research's (ICMR) National Institute of Medical Statistics officially removed the "ReAnima" trial from India's clinical trial registry on Nov. 11.

The experiment began in May when Himanshu Bansal, an orthopedic surgeon at Anupam Hospital in the north Indian state of Uttarakhand, announced plans to give approximately 20 brain-dead people a mix of interventions including injections of mesenchymal stem cells, peptides, transcranial laser stimulation and median nerve stimulation.

Transcranial laser stimulation is a process that involves shinning pulses of near-infrared light in the brain, while median nerve stimulation is the electrical stimulation of a major nerve that runs from the neck to the arm. Both techniques have been proven to improve cognition in patients with traumatic brain injury.

ᐧ

Comments

Post a Comment

Popular posts from this blog

BE guidelines regarding investigator

BE guidelines recommend investigator should possess appropriate medical qualification, experience for conducting pharmacokinetic studies Can chairperson of EC directly write to sponsor to clarify some of the queries of clinical trial raised in EC meeting? Dr. Sreevatsa Please see an extract from FDA's comment on IRB-sponsor relationship. The interrelationship and interaction between the research sponsor (e.g., drug, biologic and device manufacturers), the clinical investigator and the Institutional Review Board (IRB) may be very complex. The regulations do not prohibit direct sponsor-IRB contacts, although, the sponsor-IRB interaction customarily occurs through the investigator who conducts the clinical study. The clinical investigator generally provides the communication link between the IRB and the sponsor. Such linkage is agreed to by the sponsors and investigators when they sign forms FDA-1571 and FDA-1572, respectively, for drug and biologic studies or a...
Post a Comment
Read more

ICH GCP requires EC members to be independent of investigator and sponsor to avoid conflicts of interest

Can an Ethics Committee member e.g. layman/chairman or anyone in the committee participate in the trial as a subject? Vidya If an Ethics Committee member becomes a trial subject on a trial that he/she was involved in approving then there has been a major conflict of interest. The following situations need to be considered: ● IEC member reviews study without any prior knowledge of the study, votes, and then afterwards is approached by clinical research team to participate. Possibly this is OK but the member should no longer be part of the IEC that reviews that study. This will be difficult in practice, so therefore it is not advisable. ● IEC member already knows about the study and is voting in order to be able to participate. This is clearly not acceptable and made worse if there is additional financial incentive for the study (e.g. volunteer study). ICH GCP requires Ethics Committee members to be independent of the investigator and the sponsor to avoid confl...
Post a Comment
Read more

Combination Vaccine for Kids withdrawn

A vaccine that combines conventional MMR (Measles, Mumps, Rubella) with Chikenpox has been withdrawn in the United States due to a higher rate of seizures in children. In a study children aged 12 to 23 months who received the combined MMR cum Chickenpox vaccine had double the rate of seizures compared to children who got separate vaccine for MMR and chickenpox. This equates to one additional case of convulsion per 2000 vaccinations.
Post a Comment
Read more