Phase 1/2a Study on Allogeneic Osteoblastic Cells Implantation in Delayed-Union Fractures
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|ClinicalTrials.gov Identifier: NCT02020590|
Recruitment Status : Completed
First Posted : December 25, 2013
Last Update Posted : June 11, 2020
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.
|Condition or disease||Intervention/treatment||Phase|
|Long Bone Delayed-Union Fracture||Drug: ALLOB® implantation||Phase 1 Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||25 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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 Start Date :||February 2014|
|Actual Primary Completion Date :||September 2017|
|Actual Study Completion Date :||January 2020|
Experimental: ALLOB® Implantation
One arm: ALLOB® Implantation
Drug: ALLOB® implantation
Each patient will undergo a single administration of ALLOB® into the delayed-union site under anesthesia.
- Percentage of patients having a rescue surgery [ Time Frame: 6 months ]
- Global Disease Evaluation score as assessed by the patient [ Time Frame: 6 months ]
- Radiological healing progression as assessed by CT scan [ Time Frame: 6 months ]
- Potential occurrence of any Adverse Event or Serious Adverse Event, related to the product or to the procedure, using patient open non-directive questionnaire, physical examination and laboratory measurements [ Time Frame: 6 months ]
- Global Disease Evaluation using a Visual Analogue Scale [ Time Frame: 6 months ]
- Pain evaluation at fracture site using a Visual Analogue Scale [ Time Frame: 6 months ]
- Weight-bearing using Likert Scale [ Time Frame: 6 months ]
- Radiological healing progression as assessed by X-ray and CT-scan [ Time Frame: 6 months ]
- Cell biodistribution after implantation as assessed by SPECT/CT scan (sub-study) [ Time Frame: 72 hours ]
- Bone metabolism evaluation as assessed by SPECT/CT scan (sub-study) [ Time Frame: 6 months ]