PGI to Set Up GMP Laboratory for Advanced Stem Cell, Gene Therapies

Chandigarh: The Post Graduate Institute of Medical Education and Research (PGIMER) Chandigarh is working towards establishing its own Good Manufacturing Practice (GMP) laboratory to bring new hope to cancer patients. This initiative aims to enhance the institution's capabilities in stem cell and gene therapies, facilitating the advancement of innovative medical treatments.

Currently, PGI faces a major challenge in providing advanced treatments such as stem cell therapy, gene editing, and CAR T-cell immunotherapy due to the absence of a GMP laboratory. This facility is crucial for ensuring the highest standards of medical practices in these specialized therapies.

At present, PGI relies on external laboratories in Bengaluru and Mumbai for CAR T-cell therapy, a cutting-edge immunotherapy in which a patient's own T cells are genetically modified in a lab to recognize and attack cancer cells. After the modification, the T cells are infused back into the patient’s body to fight cancer. However, the establishment of a GMP laboratory at PGI will allow the institute to perform these advanced therapies in-house, potentially increasing accessibility for patients and reducing the cost of treatment.

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Speaking to TOI, Prof Pankaj Malhotra, head of the Department of Clinical Hematology and Medical Oncology, PGI, said, "Having our own GMP laboratory would provide self-reliance and the ability to provide these therapies to needy patients for free." He added, "We have treated some eight patients to date and it is costly. With our own set-up, we can be self-reliant and help poor patients."

The establishment of a GMP laboratory is crucial to meet the regulatory standards required for stem cell and gene therapy procedures. PGI is reportedly collaborating with Tata Memorial Hospital, Mumbai, to facilitate the establishment of the GMP laboratory, ensuring access to advanced treatments like stem cell and gene therapies at the institution itself.

Dr. Gaurav Narula, a pediatric hematologist-oncologist at TMH and a key figure in developing India’s first CAR T-cell therapy, visited PGI during a national conference on translational research.

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Speaking to TOI, Dr Narula said, "We are expanding our research into other applications of CAR T-cell therapy, including viral infections after transplant surgery in immunosuppressed patients. While the therapy currently targets hematological cancers, its potential is vast." His team shall guide PGI in developing the GMP laboratory set-up, which can cost over Rs 20 crore.

Apart from its focus on cancer therapies, PGI also aims to strengthen its research in stem cell therapies, particularly for kidney transplants. Work on stem cell research for kidney transplants, which began several years ago, had come to a standstill due to new GMP standards. Researchers have been focusing on mesenchymal stem cells (MSCs) for kidney transplants, with the process involving the extraction of these cells from patients four weeks before surgery. MSCs, a type of stem cell found in various tissues like bone marrow, have the ability to differentiate into different cell types and play a crucial role in tissue repair and regeneration.