Discussing Stem Cell Research Opportunities with a Research Site Owner

At the Site Council meeting, Darshan Kulkarni had the opportunity to speak with Mohamed Hakim, a site owner who has consolidated six clinical research sites into three. Their conversation explored the evolving landscape of clinical research, particularly in stem cell studies, in light of the regulatory shifts happening under the Trump administration. Mohamed highlighted the increasing number of clinical trials and the expansion of pharmaceutical research into Europe, creating new opportunities for site owners like himself.

One of the most exciting developments he shared was his team’s work in stem cell research. They have been conducting investigator-initiated trials, including a recent study on concussions using stem cells. The study involved 20 participants—military personnel, football players, and soccer players, both male and female—who received IV injections of stem cells. The preliminary results were highly promising, demonstrating significant potential for using stem cells in neurological recovery.

They also discussed the complex regulatory framework surrounding stem cell research. Stem cell therapies exist in a regulatory gray area, straddling the line between medical practice and drug development. The FDA has historically scrutinized stem cell treatments, particularly when manipulation is involved—such as freezing and thawing cells, which can push the therapy into the category of a drug requiring extensive clinical trials. Mohamed explained that his team is carefully navigating these challenges by ensuring compliance with FDA regulations. In California, they operate under strict guidelines, treating patients with same-day stem cell procedures to avoid regulatory pitfalls associated with long-term storage or modification.

A key aspect of their approach is leveraging the “Right to Try” law, which allows patients who have exhausted other treatment options to access investigational therapies. Mohamed noted that this has been particularly relevant in their work on conditions like concussions and Alzheimer’s. While they are not aiming to reverse Alzheimer’s, their research focuses on delaying its progression.

The discussion also touched on the commercialization of stem cell therapies. Some clinics, particularly in states like Texas, have bypassed the traditional FDA approval process by charging patients directly for experimental treatments. However, Mohamed and his team are committed to following proper research protocols and avoiding legal risks. They briefly operated a sub-site dedicated to stem cell treatments but shut it down after seeing the FDA crack down on similar operations in New York. Now, they are taking a cautious approach, waiting for regulatory clarity before expanding further.

Mohamed’s journey into stem cell research was driven by his partnership with an orthopedic surgeon and a sports medicine doctor—who was also the team doctor for the Chargers. Their initial goal was to find effective treatments to help athletes recover faster. From there, they expanded their research into broader medical applications, including orthopedic and cardiovascular conditions.