ALLOB-DU1– A bone cell therapy for delayed-union fractures
Research type
Research Study
Full title
A pilot Phase I/IIa, multicentre, open, proof-of-concept study on the efficacy and safety of allogeneic osteoblastic cells (ALLOB®) implantation in non-infected delayed-union fractures.
IRAS ID
129791
Contact name
Ines Reichert
Contact email
Sponsor organisation
Bone Therapeutics
Eudract number
2012-005333-36
Clinicaltrials.gov Identifier
Duration of Study in the UK
1 years, 10 months, 3 days
Research summary
This study is a first-in-man, open, proof-of-concept study which aims at evaluating the efficacy and safety of ALLOB®, allogeneic osteoblastic cells* in the treatment of delayed-union fractures**.
Usually delayed-union fractures are treated by the use of invasive surgery which can be related to complications.
In this study, the ALLOB® cells will be injected in a single administration through a small skin incision under anaesthesia directly into the the delayed-union fracture site. These cells are expected to produce new bone and re-establish a healthy bone environment.
It is foreseen that 32 patients diagnosed with a delayed-union fracture will be treated by a single ALLOB® injection and followed-up during a 6-month period (2 weeks, 1, 3 and 6 months after the treatment). After the last hospital visit during the active phase of the study, patients will enter a pharmacovigilance follow-up period of 24 months, composed of two phone calls.
Efficacy will be evaluated by using both, radiological and clinical examinations: patients will undergo X-Rays and CT-Scans and will be asked to fill-out a series of questionnaires to assess the pain they feel at the fracture site, the global evolution of their disease and the mobility of the fractured limb. As for the safety, in addition to the standard pharmacovigilance requirements, particular attention will be given to any event suggesting the occurrence of a rejection reaction towards the ALLOB® cells.
* Cells belonging to another person than the patient.
** Delayed-union fracture is a bone disorder characterized by a fracture that has not united within a period of time considered adequate for bone healing.REC name
London - West London & GTAC Research Ethics Committee
REC reference
14/LO/1890
Date of REC Opinion
12 Jan 2015
REC opinion
Further Information Favourable Opinion