Stem cell and regenerative medicine company Cynata Therapeutics (ASX: CYP) has enrolled its first cohort for its “world first” clinical trial of its stem cell product CYP-001 to treat steroid resistant graft versus host disease.
Graft versus host disease can occur after a bone marrow transplant where the donated marrow or peripheral blood stem cells perceive the recipient’s body as foreign and attack the body.
Cynata Therapeutics clinical trial is investigating the safety and efficacy of its mesenchymal stem cell product CYP-001 in adults with the disease.
“The completion of enrolment of the first cohort of participants in this ground-breaking trial is a significant milestone for Cynata, and we’re very much looking forward to receiving details of the interim data and the data safety and monitoring board’s recommendation,” Cynata vice president of product development Dr Kilian Kelly said.
Participant need to have undergone an allogeneic haematopoietic stem cell transplant to treat a blood disorder and then subsequently diagnosed with steroid-resistant acute graft versus host disease.
This first complete cohort includes eight participants which will receive two CYP-001 infusions each at a lower 1 million cells per kilogram dose.
Once the final participant in the cohort reaches day 28 after his or her first infusion, the independent Data Safety and Monitoring Board will conduct a review.
Cynata Therapeutics has commissioned the board to ensure an objective and independent review of subjects’ safety throughout the trial.
Following its review, the board will either recommend the trial proceeds with a second cohort or amend the protocol prior to proceeding to the second cohort, or end the study.
In the second cohort, titled cohort b, a further eight participants will be enrolled and receive two CYP-001 infusions each at a higher dose of 2 million cells per kilogram.
According to the company, there are more than 650 trials investigating the efficacy of mesenchymal stem cells in treating diseases such as osteoarthritis, stroke and cardiovascular disease.
The CYP-001 drug aims to become a disruptive and regenerative medicine that can target a broader range of diseases.