Firm claims product is first of its kind to achieve the agency’s approval.

FDA has granted 510(k) clearance for Life Technologies’ StemPro® MSC SFM culture medium for the ex vivo tissue and cell culture of human mesenchymal stem cells (MSCs). Designed to culture MSCs in an undifferentiated state, StemPro MSC SFM was first introduced in May 2009 as a research-use-only product. Life claims the serum-free culture medium is the only product of its kind to have received FDA approval.

Clearance for clinical applications means there will be one less hurdle for the development of potential cell therapies based on MSCs, the firm maintains. “A key component for stem cell research to advance into clinical trials and beyond is the ability to put validated tools into the hands of researchers,” remarks Joydeep Goswami, head of primary and stem cells at Life. “The 510(k) clearance by FDA of our STemPro MSC SFM is a pivotal step in that direction.”

Life Technologies’ Cell Therapy Systems™ portfolio already comprises a range of 510(k)-cleared products for stem cell culture, isolation, expansion, differentiation, and characterization. These include: AIM V® Medium, DMEM, KnockOut™ SR Medium, and KnockOut® SR XenoFree Medium.

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