The UK Medicines and Healthcare products Regulatory Agency (MHRA) has granted approval to Australian stem-cell and regenerative medicine company, Cynata Therapeutics, to continue its Phase I clinical trial of CYP-001 to treat steroid-resistant graft-versus-host disease (GvHD).
Cynata’s CYP-001 has been derived from allogeneic induced pluripotent stem cells (iPSCs), which are the man-made versions of embryonic stem cells.
They have the ability to reproduce themselves indefinitely, as well as differentiate into any other type of cell in the body. It can be expanded without limits and stored for a longer duration.
The Phase I trial has been titled as 'An Open-Label Phase I Study to Investigate the Safety and Efficacy of CYP-001 for the Treatment of Adults With Steroid-Resistant Acute Graft Versus Host Disease'.
The trial will involve approximately 16 subjects who underwent bone marrow transplant or similar procedure, and who were also diagnosed with steroid-resistant Grade II-IV acute GvHD.
Cynata product development vice-president Dr Kilian Kelly said: "We are delighted that the MHRA has approved our clinical trial.
“Not only does this enable us to start providing our highly promising therapy to patients with a particularly devastating disease, it also provides clear validation of our manufacturing process and preclinical development programme from one of the most highly regarded regulatory authorities worldwide."