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.
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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.
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By GlobalData“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."
