• SKIP TO CONTENT
  • SKIP NAVIGATION
  • Patient Resources
    • COVID-19 Patient Resource Center
    • Clinical Trials
    • Search Clinical Trials
    • Patient Notification System
    • What is Clinical Research?
    • Volunteering for a Clinical Trial
    • Understanding Informed Consent
    • Useful Resources
    • FDA Approved Drugs
  • Professional Resources
    • Research Center Profiles
    • Clinical Trial Listings
    • Market Research
    • FDA Approved Drugs
    • Training Guides
    • Books
    • eLearning
    • Events
    • Newsletters
    • JobWatch
    • White Papers
    • SOPs
    • eCFR and Guidances
  • White Papers
  • Trial Listings
  • Advertise
  • COVID-19
  • iConnect
  • Sign In
  • Create Account
  • Sign Out
  • My Account
Home » Bone Therapeutics completes recruitment in ALLOB phase I/IIa delayed-union study

Bone Therapeutics completes recruitment in ALLOB phase I/IIa delayed-union study

March 10, 2017
CenterWatch Staff

Bone Therapeutics, a bone cell therapy company addressing high unmet medical needs in orthopaedics and bone diseases, has completed the recruitment of the first 16 patients in its phase I/IIA delayed-union study of its allogeneic cell therapy product ALLOB. 

The ongoing phase I/IIA study is a six-month open-label trial to evaluate the safety and efficacy of ALLOB in the treatment of delayed-union fractures of long bones. The study is targeting the recruitment of 32 patients, but is flexible and could be stopped prematurely after a positive evaluation of the interim data analysis of the first 16 patients. To date, 16 patients with a fracture that has failed to consolidate after a minimum of three and a maximum of seven months, have received a single percutaneous administration of ALLOB directly into the fracture site. Fracture healing of ALLOB-treated patients is assessed using clinical (e.g. pain, weight bearing) and radiological evaluation. Initial results from the first eight patients showed that more than 85% of the patients were responder according to the protocol.

Thomas Lienard, CEO of Bone Therapeutics, commented: “The successful recruitment of 16 patients for the ALLOB phase I/IIa delayed-union study is an important milestone for the company. Positive interim results for this first set of 16 patients could allow us to stop the study early, and would further validate our allogeneic strategy and the potential benefits it can bring to patients. We are encouraged by the previously reported positive preliminary safety and efficacy results of the first eight patients and are looking forward to communicating on the results of the interim data analysis of all 16 patients in the second half of this year, following the completion of the six-month follow-up period.”

Upcoming Events

  • 24May

    Powering an Effective Oversight Strategy with Clinical and Operational Insights

  • 25May

    2022 WCG Avoca Quality & Innovation Summit: Own the Future

  • 28Jun

    Effective Root Cause Analysis and CAPA Investigations for the Life Sciences

  • 16Oct

    WCG MAGI's Clinical Research Hybrid Conference - 2022 West

Featured Products

  • Spreadsheet Validation: Tools and Techniques to Make Data in Excel Compliant

    Spreadsheet Validation: Tools and Techniques to Make Data in Excel Compliant

  • Surviving an FDA GCP Inspection

    Surviving an FDA GCP Inspection: Resources for Investigators, Sponsors, CROs and IRBs

Featured Stories

  • Protocol-360x240.png

    Avoid Deviations by Making Protocol Review a Team Effort

  • SelectionProcess-360x240.png

    Give Us a Voice: Sites Clamor for a Say on Vendor Selection

  • Convince-360x240.png

    Use Data and Details to Convince Site Leadership to Add Staff

  • AsktheExpertsBadge-360x240.png

    Ask the Experts: Listing Trial Staff and Others on the Statement of Investigator

Standard Operating Procedures for Risk-Based Monitoring of Clinical Trials

The information you need to adapt your monitoring plan to changing times.

Learn More Here
  • About Us
  • Contact Us
  • Privacy Policy
  • Do Not Sell My Personal Information

Footer Logo

300 N. Washington St., Suite 200, Falls Church, VA 22046, USA

Phone 617.948.5100 – Toll free 866.219.3440

Copyright © 2022. All Rights Reserved. Design, CMS, Hosting & Web Development :: ePublishing