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

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ClinicalTrials.gov Identifier: NCT02020590
Recruitment Status : Active, not recruiting
First Posted : December 25, 2013
Last Update Posted : July 4, 2018
Sponsor:
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

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 25 participants
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
Estimated Study Completion Date : March 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
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02020590


Locations
Belgium
Investigating site BE01
Anderlecht, Belgium
Investigating site BE03
Brussels, Belgium
Investigating site BE08
Brussels, Belgium
Investigating site BE09
Brussels, Belgium
Investigating site BE10
Brussels, Belgium
Investigating site BE02
Charleroi, Belgium
Investigating site BE05
Genk, Belgium
Germany
Investigating site DE01
Koln, Germany
Investigating site DE03
Lubeck, Germany
Investigating site DE02
Munich, Germany
Investigating site DE04
Wurzburg, Germany
United Kingdom
Investigating site UK01
London, United Kingdom
Investigating site UK02
Norwich, United Kingdom
Sponsors and Collaborators
Bone Therapeutics S.A

Responsible Party: Bone Therapeutics S.A
ClinicalTrials.gov Identifier: NCT02020590     History of Changes
Other Study ID Numbers: ALLOB-DU1
First Posted: December 25, 2013    Key Record Dates
Last Update Posted: July 4, 2018
Last Verified: November 2017

Keywords provided by Bone Therapeutics S.A:
Delayed-Union Fractures
Impaired Healing
Fractures
Orthopedics
Bone
Musculoskeletal Disorders

Additional relevant MeSH terms:
Fractures, Bone
Fractures, Ununited
Wounds and Injuries