Carmell Therapeutics has secured clearance from the US Food and Drug Administration (FDA) for its investigational new drug application (IND) for CT-101, its first product, which is a bone healing accelerant (BHA).

The Pennsylvania biotech company is engaged in the development and commercialization of plasma-based bioactive materials (PBMs) to speed up bone and soft tissue healing.

Carmell Therapeutics said that the IND clearance allows it to start patient enrollment for a multi-region, randomized, blinded study in long bone fractures to support a biologics license application (BLA) for CT-101.

The study is likely to enroll nearly 220 patients in 25 centers in the US, Europe, and South Africa.

Randy Hubbell – Carmell Therapeutics President and CEO said: “Receiving IND clearance to begin clinical trials is a key milestone in the development of our groundbreaking regenerative medicine platform technology.

“Carmell Therapeutics is now on a path to be the first company in the bone healing space with a BLA supported by two prospective, randomized, multicenter clinical studies demonstrating superiority to the current standard of care.”

“Our IND clearance for our Bone Healing Accelerant, a combination biologic and device product, indicates Carmell has made significant progress in our level of biologic product knowledge, quality system implementation, and manufacturing process validation.”

The FDA accepted the data and the overall study design from Carmell Therapeutics’ double-arm, multicenter, phase 2 clinical trial of bone healing accelerant in open tibia fractures. In the mid-stage clinical trial, bone healing accelerant delivered a considerably reduction of infections compared to controls with no adverse reactions.

bone healing accelerant showed a clear trend in the phase 2 trial towards accelerated wound healing at 30 days, and accelerated bone healing in comparison to controls.

According to Carmell Therapeutics, the bone healing acceleration was evident especially for the most severe type IIIA and IIIB open tibia fractures with extensive soft tissue injury.

Stephanie Kladakis – Carmell Therapeutics Chief Scientific Officer said: “This IND clearance is significant for us as the rigorous chemistry, controls and product manufacturing (CMC) requirements of the IND submission provide the framework for what will be submitted in the BLA application upon completion of the pivotal studies.

“To meet these stringent requirements, our ISO 13485 certified manufacturing facility includes a Class 7 Cleanroom and we have successfully manufactured multiple batches of BHA, which have consistently passed strict finished-product and long-term stability testing.”

  bone healing accelerant, Carmell Therapeutics, CT-101, long bone fractures, Randy Hubbell, Stephanie Kladakis, US Food and Drug Administration, USA