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A Double-Arm, Multicenter, Phase II Clinical trial of Bone Healing Accelerant in Open Tibia Fractures

Trial Profile

A Double-Arm, Multicenter, Phase II Clinical trial of Bone Healing Accelerant in Open Tibia Fractures

Status: Completed
Phase of Trial: Phase II

Latest Information Update: 06 Dec 2023

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At a glance

  • Drugs CT 101-carmell corporation (Primary)
  • Indications Fracture
  • Focus Proof of concept; Registrational; Therapeutic Use
  • Acronyms HEAL I
  • Sponsors Carmell Corporation; Carmell Therapeutics

Most Recent Events

  • 30 Apr 2020 New trial record
  • 27 Apr 2020 According to a Carmell Therapeutics media release, 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.
  • 27 Apr 2020 According to a Carmell Therapeutics media release, Carmells Bone Healing Accelerant (CT-101) is regulated under the U.S. FDAs Center for Biologics Evaluation and Research. The FDA accepted the data and the overall study design from this double-arm, multicenter, Phase II clinical trial of Bone Healing Accelerant in open tibia fractures.

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