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CHENNAI: Doctors at the Stem Cell Research Centre, Government Stanley Medical College Hospital (GSMCH), are in the process of recruiting patients for conducting phase I and II clinical trials of Stem Cell Therapy for end-stage liver disease to assess its safety and efficacy.
The clinical trial comes as a significant move as presently, liver transplant is the only treatment available for end-stage liver disease, but scarcity of donor organs necessitates alternative modalities. The Stem Cell Research Centre in July 2020 received approval from the Central Drug Standard Control Organisation (CDCSO) to conduct clinical trials after animal trails showed promising results, said Dr S Jeswanth, Director, Institute of Surgical Gastroenterology and Principal Investigator, Stem Cell Research Centre, GSMCH.
Dr Secunda Rupert, Co-Investigator at Stem Cell Research Centre, GSMCH told TNIE that liver transplant is currently the only option for end-stage liver disease. Many patients are on the waiting list for liver transplant. So these stem cells can be used as a bridge till they get donor liver for transplant and in some cases, it can be a wholesome therapy. We have found that in acute liver disease, the results are good, the doctor added.
According to data from the Transplant Authority of Tamil Nadu (TRANSTAN), there are 418 patients waiting for liver transplant in the State alone. The CDSCO gave approval and also directed to conduct more animal studies. We will first conduct them and then will start the clinical trials. We are in the process of recruiting patients for the trial. We couldnt recruit patients then because of the pandemic, said Secunda. A total of 30 patients will be recruited for clinical trials, and among them 15 will be put on Stem Cell Therapy and 15 on standard treatment, added Secunda.
Mesenchymal adult stem cells will be extracted from bone marrow of the patients and these will be cultured in the lab before being injected back into the patient, Secunda added. During animal studies, when we caused liver injury in the animal and injected the stem cells, there was an improvement in the injury. It showed these Mesenchymal adult stem cells can alleviate liver injury, Secunda further said.Jeswanth said the trial will be funded by the Tamil Nadu Innovative Initiative scheme (TANII).
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