A Pilot Phase 1/2a, Multicentre, Open Proof-of-concept Study on the Efficacy and Safety of Allogeneic Osteoblastic Cells (ALLOB) Implantation in Non-infected Delayed-Union Fractures

Trial Profile

A Pilot Phase 1/2a, Multicentre, Open Proof-of-concept Study on the Efficacy and Safety of Allogeneic Osteoblastic Cells (ALLOB) Implantation in Non-infected Delayed-Union Fractures

Discontinued
Phase of Trial: Phase I/II

Latest Information Update: 20 Sep 2017

At a glance

  • Drugs Allogeneic osteoblastic cell therapy Bone Therapeutics (Primary)
  • Indications Fracture
  • Focus Adverse reactions; First in man; Proof of concept; Therapeutic Use
  • Sponsors Bone Therapeutics
  • Most Recent Events

    • 20 Sep 2017 Interim results were presented in a Bone Therapeutics media release.
    • 20 Sep 2017 According to a Bone Therapeutics media release, based on the evaluation of interim data post a six-month follow-up, the Data and Safety Monitoring Board (DSMB) has recommended stopping the trial early due to the strong efficacy data. Following the positive recommendation of the DSMB the Company will stop the study recruitment immediately and prepare for the next clinical phase.
    • 20 Sep 2017 Status changed from recruiting to discontinued, according to Bone Therapeutics media release.
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