Clinical trial NCT02020590: Phase 1/2a Study on Allogeneic Osteoblastic Cells Implantation in Delayed-Union Fractures
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Long Bone Delayed-Union Fracture
Keywords: Delayed-Union Fractures
Impaired Healing
Fractures
Orthopedics
Bone
Musculoskeletal Disorders
Lead sponsor: Bone Therapeutics S.A
Sponsor class: INDUSTRY
First posted: 2013-12-25
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: Percentage of Responders at 6 Months (Efficacy of ALLOB)
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
citation: Jayankura M, Schulz AP, Delahaut O, Witvrouw R, Seefried L, Berg BV, Heynen G, Sonnet W. Percutaneous administration of allogeneic bone-forming cells for the treatment of delayed unions of fractures: a pilot study. Stem Cell Res Ther. 2021 Jun 26;12(1):363. doi: 10.1186/s13287-021-02432-4.