NCT04432389: ALLOB-TF2

Study to Assess the Efficacy and Safety of Allogeneic Osteoblastic Cells (ALLOB®) Single Implantation in Tibial Fracture

Status unknown Phase 2 Last updated 7 June 2021

What this trial tests

Phase 2 trial testing ALLOB in Tibial Fracture in 178 participants. Status unknown.

Timeline

8 January 2021

Primary endpoint
31 July 2022

31 March 2024

Quick facts

Lead sponsor	Bone Therapeutics S.A
Phase	Phase 2
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	triple
Primary purpose	treatment
Enrollment	178
Start date	8 January 2021
Primary completion	31 July 2022
Estimated completion	31 March 2024
Sites	39 locations across France, Belgium, Germany, Hungary, Poland, Spain, Czechia

Drugs / interventions tested

• ALLOB — full drug profile →
• placebo

Conditions studied

• Tibial Fracture — all drugs for Tibial Fracture →

Sponsor

Bone Therapeutics S.A — full company profile →

Who can join

18 and older, any sex, with Tibial Fracture. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.