Stemedica Cell Technologies, an adult stem cell research and manufacturing company, has been granted a licence by the US state of California to manufacture stem cells for human clinical trials.
The licence allows the company to market stem cells and stem cell-derived factors to pharmaceutical and biopharmaceutical companies, research institutions and medical facilities to conduct approved human clinical trials.
Stemedica president and chief medical officer Nikolai Tankovich said that the approval positions Stemedica as one of only a few companies in the world capable of manufacturing and delivering multiple cell products and factors.
“As more and more organisations get involved with stem cell research and clinical trials, including drug discovery programmes, Stemedica’s ability to service their needs becomes a critical asset to the organisation and to the industry,” Tankovich said.
The licence was granted after an extensive four-year inspection and approval process which included a comprehensive audit of Stemedica’s manufacturing process and procedures, examination of Stemedica’s quality systems, interviews with facility management and an onsite inspection of the facility.