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

Phase 1

• Conditions: on-infected delayed-union fractures; MedDRA version: 17.1 Level: PT Classification code 10017081 Term: Fracture delayed union System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders; Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

• Registration Number: EUCTR2012-005333-36-GB
• Lead Sponsor: Bone Therapeutics S.A.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2013-07-01
• Last Update Posted: 30 June 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 32

Inclusion Criteria

- Patient diagnosed with a non-infected delayed-union fracture of a long bone (femur, tibia, fibula, humerus, ulna, radius) of a minimum 3 months (and maximum 7 months) ± 2 weeks without signs of healing over the last 4 weeks at the time of screening
- Patient aged 18 to 70 years inclusive
- Modified Radiographic Union Scale (mRUS) < 10
- Patient capable to understand and comply with study requirements and capable to provide a written, dated, and signed informed consent prior to any study procedure for participation in the study and transmission of personal anonymized data.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 29
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 3

Exclusion Criteria

Current symptoms and/or signs related to the disease under study
- Fracture interline > 2.5 cm as defined by the Independent Radiologist
- Insufficient reduction of the fracture with displaced fragments
- Insufficient fracture stability defined as osteolysis at the level of the nails/screws and/or defect and/or mobility of the osteosynthesis material at physical examination, as assessed by the Investigator
- Osteosynthesis material revision performed less than 4 weeks from the screening visit for simple revision, defined as a second intervention anywhere but at the fracture site or less than 2 months from the screening visit for other revisions, defined as a second operation that can be an intervention at the fracture site
- Active bone infection (at site)
- Femoral neck fracture, if the femur is the target bone of the study
- Multifocal fracture (e.g., more than one fracture site on the studied bone)
- Delayed/non-union fracture on the neighbouring bone (e.g., at ulna/radius) except delayed/non-union fractures at the fibula when the tibia is the target bone for the study
- Global Disease Evaluation Score as assessed by the patient lower than 20 mm on a Visual Analogue Scale
- Severe nerve damage and/or neuropathic/neuropathic-like pain at fracture site, that may interfere with assessment during the study, as appreciated by the Investigator
- Severe tendon lesion (e.g., rupture or enthesopathy) at fracture site, that may interfere with assessment during the study, as appreciated by the Investigator

Current or previous diagnoses, signs and/or symptoms
- Positive serology for HIV (defined as positive Anti-HIV 1 and/or 2)
- Active hepatitis B or C (defined as positive HBs Ag and/or positive PCR)
- Global sepsis
- Haemoglobin level <10 g/dl
- Renal impairment, defined as serum creatinine >2 mg/dl or 176 µmol/L
- Hepatic impairment, defined as alanine aminotransferase or aspartate aminotransferase = 3 times the upper normal limit
- Poorly controlled diabetes mellitus (defined as HbA1C >8%)
- Clinically relevant abnormal ECG (>6-lead) at screening, as judged by the Investigator or any medically qualified member of his team
- Known Allergy to gentamicin
- Current or past history of solid or haematological neoplasia or bone marrow transplantation
- Active autoimmune disease (e.g., sclerodermia, Sjögren syndrome, lupus,...)
- Any concomitant disease that could interfere with the evaluation of efficacy, as judged by the investigator, including but not limited to local or metabolic bone diseases (e.g., severe fractural osteoporosis, osteogenesis imperfecta, primary hyperparathyroidism, renal osteodystrophy, fibrous and osteopetrosis, Paget’s disease, hemochromatosis, or collagen gene mutations).
- Life expectancy less than 6 months

Current or previous treatment
- Patients who have previously been treated with ALLOB®
- Participation in another clinical study involving a pharmacological treatment within 3 months prior to screening
- Current or past treatment for cancer or blo

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified