- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02020590
Phase 1/2a Study on Allogeneic Osteoblastic Cells Implantation in Delayed-Union Fractures
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
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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Phase 2
- Phase 1
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: NA
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: ALLOB® Implantation
One arm: ALLOB® Implantation
|
Each patient will undergo a single administration of ALLOB® into the delayed-union site under anesthesia.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Percentage of Responders at 6 Months (Efficacy of ALLOB)
Time Frame: 6 months
|
The success of the study will be based on the percentage of treated patients (ALLOB®) not failing under treatment.
A patient will be considered as failed under treatment if, at Month 6: - He/she had a rescue surgery Or - The Global Disease Evaluation score (VAS) as perceived by the patient has not improved by at least 25% and the Tomographic Union Score (TUS) as assessed by CT scan has not increased by at least two points (versus baseline).
|
6 months
|
Collaborators and Investigators
Sponsor
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- ALLOB-DU1
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Long Bone Delayed-Union Fracture
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Sohag UniversityRecruitingInfected Non Union and Delayed Union in Fractures of Both Long and Short BonesEgypt
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University Hospital MuensterCompletedLong Bone Non-union
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The Affiliated Nanjing Drum Tower Hospital of Nanjing...CompletedFracture | Delayed Union of FractureChina
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Hadassah Medical OrganizationUnknownNon Union/Delayed FracturesIsrael
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Bone Therapeutics S.ACompletedBone Fracture | Validation Studies | Fracture Healing | X-Ray | Delayed Union Fracture | CT-scanGermany
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University of LouisvilleRecruitingTibial Fractures | Nonunion of Fracture | Delayed Union of FractureUnited States
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McGill University Health Centre/Research Institute...CompletedMalunion of Fracture of Clavicle | Delayed Union of Fracture of ClavicleCanada
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Institut National de la Santé Et de la Recherche...CompletedDelayed Union After Fracture of Humerus, Tibial or FemurSpain, France, Germany, Italy
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Assiut UniversityUnknown
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University of Wisconsin, MadisonWithdrawnNon-union or Delayed Healing FracturesUnited States
Clinical Trials on ALLOB® implantation
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Bone Therapeutics S.ATerminatedFailed Lumbar FusionBelgium
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Bone Therapeutics S.ACompletedDegenerative Disc DiseaseBelgium
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Bone Therapeutics S.AICON plcRecruitingTibial FractureBelgium, Czechia, France, Germany, Hungary, Poland, Spain
-
Perouse MedicalEclevar MedtechCompletedPeripheral Arterial Disease | Marfan Syndrome | Ehlers-Danlos Syndrome | Aneurysm Arterial | Arterial DissectionsFrance
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Aesculap AGCompletedIncisional Hernia RepairGermany
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Swiss Vision NetworkActive, not recruitingGlaucoma | Glaucoma, Open-Angle | Glaucoma, Angle-Closure | Glaucoma, Primary Open Angle
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Cantonal Hospital of St. GallenTerminatedAbdominal Aortic AneurysmSwitzerland
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pfm medical agAix Scientifics; Crolll Gmbh; Bayes GmbH; GfE Medizintechnik GmbH; pfm medical titanium...Completed