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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. Identifier: NCT02020590
Recruitment Status : Completed
First Posted : December 25, 2013
Last Update Posted : June 11, 2020
Information provided by (Responsible Party):
Bone Therapeutics S.A

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.

Condition or disease Intervention/treatment Phase
Long Bone Delayed-Union Fracture Drug: ALLOB® implantation Phase 1 Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 25 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Study Start Date : February 2014
Actual Primary Completion Date : September 2017
Actual Study Completion Date : January 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Fractures

Arm Intervention/treatment
Experimental: ALLOB® Implantation
One arm: ALLOB® Implantation
Drug: ALLOB® implantation
Each patient will undergo a single administration of ALLOB® into the delayed-union site under anesthesia.

Primary Outcome Measures :
  1. Percentage of patients having a rescue surgery [ Time Frame: 6 months ]
  2. Global Disease Evaluation score as assessed by the patient [ Time Frame: 6 months ]
  3. Radiological healing progression as assessed by CT scan [ Time Frame: 6 months ]
  4. 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 ]

Secondary Outcome Measures :
  1. Global Disease Evaluation using a Visual Analogue Scale [ Time Frame: 6 months ]
  2. Pain evaluation at fracture site using a Visual Analogue Scale [ Time Frame: 6 months ]
  3. Weight-bearing using Likert Scale [ Time Frame: 6 months ]
  4. Radiological healing progression as assessed by X-ray and CT-scan [ Time Frame: 6 months ]
  5. Cell biodistribution after implantation as assessed by SPECT/CT scan (sub-study) [ Time Frame: 72 hours ]
  6. Bone metabolism evaluation as assessed by SPECT/CT scan (sub-study) [ Time Frame: 6 months ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
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Responsible Party: Bone Therapeutics S.A Identifier: NCT02020590    
Other Study ID Numbers: ALLOB-DU1
First Posted: December 25, 2013    Key Record Dates
Last Update Posted: June 11, 2020
Last Verified: June 2020
Keywords provided by Bone Therapeutics S.A:
Delayed-Union Fractures
Impaired Healing
Musculoskeletal Disorders
Additional relevant MeSH terms:
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Fractures, Bone
Fractures, Ununited
Wounds and Injuries