Clinical Trials Logo

Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04432389
Other study ID # 000013/BT
Secondary ID
Status Recruiting
Phase Phase 2
First received
Last updated
Start date January 8, 2021
Est. completion date March 31, 2024

Study information

Verified date June 2021
Source Bone Therapeutics S.A
Contact Olivier Godeaux, MD
Phone +32 (0)71 121000
Email clinicaltrials@bonetherapeutics.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Although the majority of tibial fractures heal normally, some fractures may not heal within the usual time frame and is known as delayed bone healing within 4 to 6 months and absence of bone healing within 9 to 12 months in the most severe case of. Several factors can increase the risks of delayed healing complications like, for example, smoking, violent shocks (for example, due to a road accident) or even the type of fracture (an open fracture). The location of the fracture is also an important factor: among the bones of the arms and legs, the tibia is known for being the most at risk for complications. At tibial fracture with several risk factors could lead to delayed complications and interfere with patient daily life and reduce the quality of life. The study drug, ALLOB®, is constituted of bone cells produced from the bone marrow of healthy adult donors. Preclinical studies have shown that ALLOB® cells are capable of forming bone and repairing fractures. When directly injected into a fracture, ALLOB® should therefore promote the healing of the fracture by re-establishing a healthy environment and stimulating bone production. To date, there is no treatment for fractures considered at risk of delayed complications. The current practice on diagnosis of complications is to wait at least 6-12 months before considering alternative interventions to promote fracture healing. The injection of ALLOB® quickly after the fracture should stimulate bone healing, reduce healing time, reduce complications, and improve the quality of life for the patient. ALLOB® has already shown preliminary evidence of effectiveness in the treatment of delayed bone healing fractures (ALLOB-DU1 clinical trial), including tibial fractures (8 patients). With this study, the Sponsor will evaluate whether ALLOB® promotes the healing of tibial fractures compared with placebo.


Recruitment information / eligibility

Status Recruiting
Enrollment 178
Est. completion date March 31, 2024
Est. primary completion date July 31, 2022
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: 1. Men and women at least 18 years of age 2. Subject diagnosed with a fresh proximal, midshaft or distal tibial fracture with definitive reduction performed with nail(s) and wound closure within 1 week of fracture occurrence 3. Mechanism of injury at risk of DU/NU: fracture occurring because of a high energy impact 4. At increased risk of DU/NU defined by: - Severe open fracture (Gustilo-Anderson grade IIIa and IIIb) OR - Open (Gustilo-Anderson grade I-II) or closed (Tscherne grade II-III) fracture with at least one additional risk factor among smoking , comminuted fracture or cortical continuity (0-50%) 5. Ability to obtain a written, dated, and signed informed consent prior to any study related procedures and ability to understand and comply with study requirements Exclusion Criteria: 1. Definitive reduction at the fracture site under investigation performed with plate, screw or external fixator 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 4. Known osteomyelitis at the fracture site under investigation 5. 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. Bifocal or multifocal fracture at the site under investigation 9. Presence of fever (defined as body temperature = 38°C) or other signs/symptoms suggestive of active infection before randomization 10. Severe brain trauma with a Glasgow Coma Scale (GCS) [3 - 8] or severe spinal cord injury with impossibility of weight-bearing 11. Current or history (within 5 years) of any neoplasia (except for basal cell carcinoma of the skin and for carcinoma in situ of the cervix that has been treated with no evidence of recurrence) 12. Known metabolic diseases potentially interfering with bone healing as judged by the Investigator, such as thyroid dysfunction, Paget disease or severe osteoporosis 13. Planned or history of solid organ transplantation or bone marrow transplantation 14. Known disease, including genetic disease, that may possibly need solid organ transplantation 15. Subject with renal impairment requiring dialysis or with clinically significant renal impairment defined as serum creatinine >2.0 x ULN 16. Clinically significant hepatic function impairment defined as ALT/AST levels > 3x ULN or total bilirubin levels > 2 x ULN 17. Known hematologic disease as evidenced by hematocrit < 25%, white blood cell < 2,500/ul or platelet values < 100,000/ul without another explanation 18. Subject with an history of long standing poorly controlled chronic hypertension or diabetes that could put him at risk of needing a kidney transplant later on according to the Investigator 19. History of hypersensitivity to human biological material including blood and blood derived products 20. Known allergy to DMSO, dextran, gentamicin and any other aminoglycosides 21. Participation in another interventional clinical study within 3 months prior to screening 22. Any chronic intake of medication within one month that might affect bone metabolism or the quality of bone formation such as but not limited to bisphosphonates, teriparatide, systemic steroids, anticoagulant therapies, methotrexate and other immunosuppressant drugs or related immunotherapy 23. Previous (within 10 years) treatment with bisphosphonates 24. Current treatment with bone morphogenic protein or any other osteo-biologic intervention at the site of the tibial fracture

Study Design


Related Conditions & MeSH terms


Intervention

Biological:
ALLOB
After thawing, ALLOB® is a ready-to-use product for local administration at fracture site.
Other:
placebo
Placebo injected is a saline solution injectable grade (4 mL of 0.9% NaCl) filled in single-dose vial

Locations

Country Name City State
Belgium Tf2-Be-05 Anderlecht
Belgium Tf2-Be-03 Genk
Belgium Tf2-Be-04 Leuven
Belgium Tf2-Be-01 Lodelinsart
Czechia Tf2-Cz-01 Ceské Budejovice
Czechia Tf2-Cz-05 Jindrichuv Hradec
Czechia Tf2-Cz-03 Kladno
Czechia Tf2-Cz-04 Nový Jicín
Czechia Tf2-Cz-02 Praha
Czechia Tf2-Cz-06 Praha
France Tf2-Fr-04 Amiens
France Tf2-Fr-06 Amiens
France Tf2-Fr-01 Brest
France Tf2-Fr-02 Chambray-lès-Tours
France Tf2-Fr-06 Poitiers
Germany Tf2-de-04 Gießen
Germany Tf2-de-06 Luebeck
Germany Tf2-de-02 Mannheim
Germany Tf2-de-01 Münster
Hungary Tf2-Hu-01 Budapest
Hungary Tf2-Hu-06 Eger
Hungary Tf2-Hu-05 Kaposvár
Hungary Tf2-Hu-02 Pécs
Hungary Tf2-Hu-03 Székesfehérvár
Hungary Tf2-Hu-04 Szolnok
Poland Tf2-Pl-12 Kielce
Poland Tf2-Pl-08 Kraków
Poland Tf2-Pl-02 Lódz
Poland Tf2-Pl-01 Szczecin
Poland Ft2-Pl-07 Warszawa
Poland Tf2-Pl-06 Warszawa
Spain Tf2-Es-09 Badalona
Spain Tf2-Es-02 Barcelona
Spain Tf2-Es-03 Barcelona
Spain Tf2-Es-07 Barcelona
Spain Tf2-Es-08 Barcelona
Spain Tf2-Es-06 Málaga
Spain Tf2-Es-05 Pontevedra
Spain Tf2-Es-01 Terrassa

Sponsors (2)

Lead Sponsor Collaborator
Bone Therapeutics S.A ICON plc

Countries where clinical trial is conducted

Belgium,  Czechia,  France,  Germany,  Hungary,  Poland,  Spain, 

Outcome

Type Measure Description Time frame Safety issue
Primary proportion of subjects with a radiological success at Week 12 A radiological success is defined as a subject with a Radiological Union Score for Tibia (RUST) above the threshold value predictive of a normal bone healing. 12 weeks
Secondary Proportion of subjects with radiological success at Week 16, Week 20 and Month 6 A radiological success is defined as a subject with a Radiological Union Score for Tibia (RUST) above the threshold value predictive of a normal bone healing. 16 weeks - 20 weeks - 6 months
Secondary Change in Radiographic Union Score for Tibia (RUST) at Week 12, Week 16, Week 20 and Month 6 compared to baseline visit Radiological fracture healing is defined by a radiological fracture union evaluated and adjudicated by Independent Radiologists. weeks 12 - 16 - 20 - 6 months
See also
  Status Clinical Trial Phase
Terminated NCT01927575 - Pilot Study Comparing Diagnostic Imaging Versus Tomosynthesis in Detection of Hip, Wrist or Tibia Injury N/A
Completed NCT01017094 - Pin Site Infection Prevention for Open Tibial Fracture Phase 3
Completed NCT00038129 - SPRINT - Randomized Trial of Tibial Fracture Fixation N/A
Recruiting NCT01795287 - Safety of Spinal Anesthesia in Patients With Tibial Shaft Fracture N/A
Terminated NCT01300520 - The Development of a Surgical Localizing Aid Medical Device N/A
Active, not recruiting NCT05012449 - Transitional Ankle Fracture Management Using a New Joystick Technique N/A
Suspended NCT00365573 - Doppler Ultrasonography Evaluation of Tibial Fracture Site Vascularity Phase 2
Completed NCT02820363 - Study Evaluating CERAMENTâ„¢|G in Open Diaphyseal Tibial Fractures N/A
Completed NCT00264511 - Hyperbaric Oxygen in Lower Leg Trauma Phase 2/Phase 3
Completed NCT04028908 - Remodelling After Trampoline Fracture in Children
Completed NCT02140528 - Allogeneic Mesenchymal Stem Cell Transplantation in Tibial Closed Diaphyseal Fractures Phase 2
Active, not recruiting NCT03598530 - Fracture-Related Outcome Study for Operatively Treated Tibia Shaft Fractures
Not yet recruiting NCT01955577 - Vitamin D Supplement for Patients With Tibial Fracture Phase 1
Completed NCT00250302 - Autologous Implantation of Mesenchymal Stem Cells for the Treatment of Distal Tibial Fractures Phase 1/Phase 2
Unknown status NCT02035917 - Comparison of Tibial Plateau Fractures Outcomes Treated With Non-locking and Locking Plate N/A