AT THE end of March, a New Delhi-based clinic informed Aditya Bhatia that it could no longer continue the stem cell treatment it had been giving him for five years for his condition of muscular dystrophy. On Tuesday, the 29-year-old athlete and businessman filed a writ petition in Delhi High Court asking that the “life sustaining treatment” be allowed. The court is set to hear the case on Friday.
The writ petition states that under Article 21 of the Constitution, Bhatia’s fundamental right to life and personal liberty has been violated with discontinuation of the stem cell treatment that he was undergoing, and an interim status quo must be permitted until clinics manage to procure licence for stem cells.
On a video call, Bhatia slowly mouths his words. “Muscles in my face, shoulder and arms have become weak again. Imagine simple acts of speaking, smiling, kissing, lifting a cup. I can’t perform them easily.”
On March 19, the Union Health Ministry had notified New Drugs and Clinical Trial Rules, 2019, which for the first time include “stem cell derived products” as “new drugs”.
“This includes all types of stem cells, bone marrow concentrate or embryonic cells,” said Dr Geeta Jotwani, senior scientist at Indian Council of Medical Research. The new rules will now require a clinic to attain licence from central licensing authority for clinical trials, marketing, usage or treatment of stem cell for any condition.
In his petition, Bhatia argues that the approvals for stem cell will take months, meanwhile causing “debilitating effects” on him.
Bhatia was diagnosed in 2012 with Facioscapulohumeral (FSHD) Muscular Dystrophy, a rare genetic disorder that degenerates muscles. He had just finished graduation in marketing honours in UK. The first symptoms were difficulty in raising arms. With no available cure, the muscles continued to weaken, affecting his face, shoulders and arms.
In 2013, Bhatia started the contentious embryonic stem cell treatment at Nutech Mediworld. According to experts, the procedure remains at an experimental stage with no clinical trial proving its efficacy, and is highly debated for using laboratory cultivated human embryos to derive stem cells. Stem cells are used, with no evidence, to treat a number of disorders, from autism to Parkinson’s disease.
For five years, Bhatia would be injected with stem cells daily — the myoblast cells are used to repair and regrow muscles. Along with physiotherapy, he was able to participate in an international kettlebell tournament, a Russian weight-lifting sport, in Delhi in 2016, 2017 and 2019, organised by an organisation called International Kettlebell and Fitness Federation that has held other tournaments in Europe. In the 2019 tournament, says Bhatia, he lifted an 8 kg kettlebell doing 170 repetitions in 10 minutes.
“I competed with normal athletes,” he says. “I know that the stem cells at least worked for me. Since it has stopped, I can feel my muscles weaken. I have left my family business as I feel weak all the time.”
An official from Nutech Mediworld said all stem cell procedures have been halted for multiple patients and a number of disorders since the new rules. “A decision to whether we will apply for licence has not been taken,” the official said.
Stem cell experts and neurosurgeons have reacted differently to the new rules. “Someone’s treatment cannot be discontinued halfway. Sudden rules like this may be considered inhumane,” said Dr Alok Sharma, head of neurosurgery in Mumbai’s Sion hospital. “Only pharmaceutical companies have that kind of resources and time to get a drug approved, not doctors or small clinics,” Sharma added.
Dr Pradeep Mahajan, CMD of StemRx Bioscience Solutions, however, said that stem cells are currently regulated under no law in India. “The move of government to bring in some rules is welcome. We need more clarity on application of stem cells.” Multiple experts The Indian Express contacted also said patients cannot be given false hope with stem cells.
According to Muscular Dystrophy Foundation of India, there are 1,800 patients registered in country. About 45 of them were undergoing stem cell treatment and have shown improvement. The foundation’s website states it has temporarily suspended the treatment.
In 2017, the ICMR published guidelines on conditions for which stem cells could be administered. Muscular dystrophy was not in the list. The guidelines raised concern over possible commoditisation of embryos to develop human embryo stem cells. It also mandated only clinicians with domain knowledge to conduct stem cell trials.
In the latest case, Dr Geeta Shroff, who handles NuTech Mediworld, is a gynaecologist-turned infertility expert who ventured into stem cell treatment. Her claims of stem cell treatment have been contested by multiple experts and journals.