Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Phase 1/2a Study on Allogeneic Osteoblastic Cells Implantation in Delayed-Union Fractures

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02020590
Recruitment Status : Completed
First Posted : December 25, 2013
Last Update Posted : June 11, 2020
Sponsor:
Information provided by (Responsible Party):
Bone Therapeutics S.A

Tracking Information
First Submitted Date  ICMJE December 19, 2013
First Posted Date  ICMJE December 25, 2013
Last Update Posted Date June 11, 2020
Study Start Date  ICMJE February 2014
Actual Primary Completion Date September 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 5, 2016)
  • Percentage of patients having a rescue surgery [ Time Frame: 6 months ]
  • Global Disease Evaluation score as assessed by the patient [ Time Frame: 6 months ]
  • Radiological healing progression as assessed by CT scan [ Time Frame: 6 months ]
  • Potential occurrence of any Adverse Event or Serious Adverse Event, related to the product or to the procedure, using patient open non-directive questionnaire, physical examination and laboratory measurements [ Time Frame: 6 months ]
Original Primary Outcome Measures  ICMJE
 (submitted: December 19, 2013)
  • Percentage of patients having a rescue surgery [ Time Frame: 6 months ]
  • Global Disease Evaluation using a Visual Analogue Scale [ Time Frame: 6 months ]
  • Radiological healing progression as assessed by CT scan [ Time Frame: 6 months ]
  • Potential occurrence of any AE or SAE, related to the product or to the procedure, using patient open non-directive questionnaire, physical examination and laboratory measurements [ Time Frame: 6 months ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: April 11, 2017)
  • Global Disease Evaluation using a Visual Analogue Scale [ Time Frame: 6 months ]
  • Pain evaluation at fracture site using a Visual Analogue Scale [ Time Frame: 6 months ]
  • Weight-bearing using Likert Scale [ Time Frame: 6 months ]
  • Radiological healing progression as assessed by X-ray and CT-scan [ Time Frame: 6 months ]
  • Cell biodistribution after implantation as assessed by SPECT/CT scan (sub-study) [ Time Frame: 72 hours ]
  • Bone metabolism evaluation as assessed by SPECT/CT scan (sub-study) [ Time Frame: 6 months ]
Original Secondary Outcome Measures  ICMJE
 (submitted: December 19, 2013)
  • Pain using a Visual Analogue Scale [ Time Frame: 6 months ]
  • Weight-bearing using Likert Scale [ Time Frame: 6 months ]
  • Radiological healing progression as assessed by X-ray [ Time Frame: 6 months ]
  • Cell biodistribution after implantation (sub-study) as assessed by SPECT/CT scan [ Time Frame: 72 hours ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Phase 1/2a Study on Allogeneic Osteoblastic Cells Implantation in Delayed-Union Fractures
Official Title  ICMJE 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
Brief Summary

Fracture healing is a complex physiological process caused by interaction of cellular elements, cytokines and signaling proteins, which results in the formation of new bone. There is for now no universally accepted approach to evaluate the progression of fracture healing. Typically, a fracture is considered as a delayed-union when the bone has not united within a period of time that would be considered adequate for bone healing. Delayed-union suggests that union is slow but will eventually occur without additional surgical or non-surgical intervention, whereas non-union is defined as the cessation of all reparative process of healing.

The incidence of impaired healing is estimated to range from 5 to 10% of all long bone fractures, depending on the fracture site, the type and degree of injury, among other factors. Currently the treatment of choice remains bone allograft or autograft. This procedure shows in general good results but requires an invasive surgery of several hours under general anesthesia, followed by a few days of hospitalization. Because of this, major complications have been reported in up to 20-30% of patients.

The present Phase 1/2a study aims at demonstrating the safety and efficacy of ALLOB®, a proprietary population of allogeneic osteoblastic cells, in the treatment of delayed-union fractures of long bones. In this study, delayed-union is defined at the time of screening as an absence of healing of minimum 3 months and maximum 7 months (+/- 2 weeks) after the onset of the fracture.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Phase 2
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Long Bone Delayed-Union Fracture
Intervention  ICMJE Drug: ALLOB® implantation
Each patient will undergo a single administration of ALLOB® into the delayed-union site under anesthesia.
Study Arms  ICMJE Experimental: ALLOB® Implantation
One arm: ALLOB® Implantation
Intervention: Drug: ALLOB® implantation
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: November 23, 2017)
25
Original Estimated Enrollment  ICMJE
 (submitted: December 19, 2013)
35
Actual Study Completion Date  ICMJE January 2020
Actual Primary Completion Date September 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Patient (or patient's legally acceptable representative) capable to provide a written, dated, and signed informed consent prior to any study related procedure
  • Non-infected delayed-union fracture of a long bone of minimum 3 months and maximum 7 months (+/- 2 weeks)

Exclusion Criteria:

  • Fracture interline larger than 2.5 cm
  • Insufficient fracture stability
  • Multifocal fracture
  • Positive serology for hepatitis B, hepatitis C, Human Immunodeficiency Virus (HIV)
  • Current or past medical disease that could interfere with the evaluation of the safety and efficacy, as judged by the investigator
  • Severe renal or hepatic impairment
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries Belgium,   Germany,   United Kingdom
 
Administrative Information
NCT Number  ICMJE NCT02020590
Other Study ID Numbers  ICMJE ALLOB-DU1
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Bone Therapeutics S.A
Study Sponsor  ICMJE Bone Therapeutics S.A
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Bone Therapeutics S.A
Verification Date June 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP