ICBII Update on the Road to the Cure - February 2023

Category: Road to the Cure

A Real-Time Science Report
Ram S. Bhatt, PhD., Chief Science Officer


There has been a lot of talk recently on social media about promises of cell therapies. In fact, the media has been talking about this for the last 35 to 40 years. Yet, after nearly four decades’ extensive research and development, cell therapies remain an experimental therapy. However, stem cell therapy indeed has a tremendous potential to revolutionize treatment of devastating diseases ranging from cancer to neurodegenerative diseases such as Alzheimer’s, Parkinson’s, and many other brain diseases. 

Before cell therapies reach their “prime time”, many challenges must be overcome, paramount of which is “safety”. However, because cell therapies are complex and varied, safety testing methods, and risk assessments they entail, are complex and varied as well. The safety testing of cell therapy products was discussed at the Process Development for Cell Therapies Summit, an event that took place October 18-20, 2022. If there was a consensus, it was this: Cell Therapy, as a new field, needs novel testing techniques and personnel with the appropriate expertise. In simple words, even after four decades of research and, perhaps, tens of billions of dollars of R&D budget, scientists yet have to iron out all the problems relating to stem cells’ safety and purity.  

There is no “one size fits all” when it comes to testing the safety of cell therapy products. Instead, a variety of safety challenges may be encountered. Particularly, “challenges faced include having the technical expertise to run the many molecular, cellular, and other tests required to fully characterize and understand the product”. 

Potential Tumorigenesis of Stem Cell Therapy
Tumorigenesis is the gain of malignant properties in normal cells.  In 2019, scientists from Stanford University published an article: Tumor Formation of Adult Stem Cell Transplant in Rodent Arthritic Joints [Mol. Imaging Biol, 20 (1), 95 (2019)]. Stem cells derived from adipose tissues were implanted into 24 rats with osteochondral defects of the distal femur, including ten athymic rats (immune compromised rats lacking thymus gland to avoid rejection of transplant), and two immunocompetent control rats. All rodents underwent MRI analysis up to six weeks post-transplantation to monitor joint defect repair. In athymic rats, 9 cell transplants increased in size in the implanted area and developed into invasive tumors.   

Bottom Line
Parkinson’s patients must consult their physicians before rushing into the experimental stem cell therapy. As stated above, safety and purity related challenges must be overcome before realizing the full potential of this therapy.

ADDITIONALLY, WOULD YOU LIKE TO HELP get ICBII’s drugs to market faster? The joy of being a part of these historical events can be had by helping ICBII find the funds to bring these trials to fruition through your investing, and by finding others with the financial ability and humanitarian mindset to accomplish the, until now, impossible. Please contact ICBII directly through their website ICBII.com or by phone 858-455-9880, or contact Jo Rosen at PRO for a personal introduction to the scientists.

IMAGINE the world without Parkinson’s, MSA, or Alzheimer’s disease.


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Updated: August 16, 2017