NCT02020590

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

Completed Phase 1/Phase 2 Results posted Last updated 9 November 2021

What this trial tests

Phase 1/Phase 2 trial testing ALLOB® implantation in Long Bone Delayed-Union Fracture in 25 participants. Completed in 30 January 2020.

Timeline

1 February 2014

Primary endpoint
1 September 2017

30 January 2020

Quick facts

Lead sponsor	Bone Therapeutics S.A
Phase	Phase 1/Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	25
Start date	1 February 2014
Primary completion	1 September 2017
Estimated completion	30 January 2020

Drugs / interventions tested

• ALLOB® implantation — full drug profile →

Conditions studied

• Long Bone Delayed-Union Fracture — all drugs for Long Bone Delayed-Union Fracture →

Sponsor

Bone Therapeutics S.A — full company profile →

Who can join

Adults 18 to 80, any sex, with Long Bone Delayed-Union Fracture. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

• 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 increas

Sponsor's own description

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.

Publications & conference data

3 peer-reviewed publications reference this trial (live from Europe PMC):

1. Clinical application of mesenchymal stem cell in regenerative medicine: a narrative review.
   Margiana R, Margiana R, Margiana R, Markov A, et al · · 2022 · cited 263× · PMID 35902958 · DOI 10.1186/s13287-022-03054-0
2. Frontiers in non-union research.
   Gómez-Barrena E, Padilla-Eguiluz NG, Rosset P. · · 2020 · cited 18× · PMID 33204499 · DOI 10.1302/2058-5241.5.190062
3. Percutaneous administration of allogeneic bone-forming cells for the treatment of delayed unions of fractures: a pilot study.
   Jayankura M, Schulz AP, Delahaut O, Witvrouw R, et al · · 2021 · cited 12× · PMID 34174963 · DOI 10.1186/s13287-021-02432-4