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Clinical Trials/EUCTR2018-001054-96-HU
EUCTR2018-001054-96-HU
Active, not recruiting
Phase 1

Phase IIb, Placebo-Controlled, Randomized, Double-blind, Multicenter Study to Assess the Efficacy and Safety of Allogeneic Osteoblastic Cells (ALLOB) Single Implantation in Tibial Fracture - ALLOB-TF2

Bone Therapeutics S.A.0 sites178 target enrollmentFebruary 27, 2020
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Overview

Phase
Phase 1
Intervention
Not specified
Conditions
Not specified
Sponsor
Bone Therapeutics S.A.
Enrollment
178
Status
Active, not recruiting
Last Updated
4 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
February 27, 2020
End Date
TBD
Last Updated
4 years ago
Study Type
Interventional clinical trial of medicinal product
Sex
All

Investigators

Sponsor
Bone Therapeutics S.A.

Eligibility Criteria

Inclusion Criteria

  • •All subjects must satisfy ALL of the following criteria to be included in the study:
  • •1\. Men and women at least 18 years of age
  • •2\. Subject diagnosed with a fresh proximal, midshaft or distal tibial fracture with stable definitive reduction and stabilization performed with nail(s) and wound closure (as required) within 14 days of fracture occurrence. This time window of 14 days allows for potential intermediate stabilization, wound cleaning and closure.
  • •3\. Factor(s) at risk of DU/NU:
  • •\-Mechanism of injury: High energy impact fracture
  • •\-Any 2 of following patient\-related factors: current smoker, chronic NSAID use, high Body Mass Index BMI (\>30\), polytrauma
  • •4\. Soft\-tissue injury pattern including:
  • •\-Severe open fracture (Gustilo\-Anderson grade IIIa and IIIb)
  • •\-Open fracture (Gustilo\-Anderson grade I\-II) with at least one additional risk (current smoker, chronic NSAID use, high BMI (\>30\), polytrauma, comminuted fracture or cortical continuity \=50%)
  • •\-Closed fracture (Tscherne grade I\-III) with at least one additional risk (current smoker, chronic NSAID use, high BMI (\>30\), polytrauma, comminuted fracture or cortical continuity \= 50%)

Exclusion Criteria

  • •Current symptoms and/or signs related to the disease under study:
  • •1\. Definitive reduction at the fracture site under investigation performed with plate, screw, or external fixator (Note: It is acceptable to first stabilize the fracture with an external fixator prior to definitive stabilization with intramedullary nail)
  • •2\. Subjects who did not receive a standard antibiotic prophylaxis before definitive reduction at the fracture site under investigation
  • •3\. Intra\-articular tibial pilon and/or plateau fracture at the site under investigation (i.e., AO classification 41B; 41C; 43B; 43C)
  • •4\. Known osteomyelitis at the fracture site under investigation
  • •5\. Residual bone defect post\-definitive reduction greater than 1cm at least on 2 cortices at the fracture site under investigation
  • •6\. Fracture requiring vascular surgery at the site under investigation
  • •7\. Pathological fractures as judged by the Investigator, such as tumor or metabolic bone disease
  • •8\. Multi\-segmental fracture at the site under investigation (where there are more than 2 separate segments and thus requiring more than a single dose of the investigational product)
  • •Current or previous diagnoses, signs and/or symptoms:

Outcomes

Primary Outcomes

Not specified

Similar Trials

Active, not recruiting
Phase 1
Study to Assess the Efficacy and Safety of ALLOB in Tibial FractureTibial fracture considered at risk of DU/NU (based on the combination of risk factors documented to be associated with increased proportion of DU/NU).MedDRA version: 20.0Level: PTClassification code 10043827Term: Tibia fractureSystem Organ Class: 10022117 - Injury, poisoning and procedural complicationsTherapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
EUCTR2018-001054-96-CZBioSenic S.A.57
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Study to Assess the Efficacy and Safety of ALLOB in Tibial FractureTibial fracture considered at risk of DU/NU (based on the combination of risk factors documented to be associated with increased proportion of DU/NU).MedDRA version: 20.0Level: PTClassification code 10043827Term: Tibia fractureSystem Organ Class: 10022117 - Injury, poisoning and procedural complicationsTherapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
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Study to Assess the Efficacy and Safety of ALLOB in Tibial Fracture
EUCTR2018-001054-96-PLBioSenic S.A.57
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Study to Assess the Efficacy and Safety of ALLOB in Tibial FractureTibial fracture considered at risk of DU/NU (based on the combination of risk factors documented to be associated with increased proportion of DU/NU).MedDRA version: 20.0Level: PTClassification code 10043827Term: Tibia fractureSystem Organ Class: 10022117 - Injury, poisoning and procedural complicationsTherapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
EUCTR2018-001054-96-FRBone Therapeutics S.A.178
Active, not recruiting
Phase 1
Study to Assess the Efficacy and Safety of ALLOB in Tibial FractureTibial fracture considered at risk of DU/NU (based on the combination of risk factors documented to be associated with increased proportion of DU/NU).MedDRA version: 20.0Level: PTClassification code 10043827Term: Tibia fractureSystem Organ Class: 10022117 - Injury, poisoning and procedural complicationsTherapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
EUCTR2018-001054-96-ESBone Therapeutics S.A.178