A Phase IIA, multicentre, open study on the safety and efficacy of allogeneic osteoblastic cells (ALLOB®) implantation in multiple non-infected delayed-union (DU) fractures

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 12

Inclusion Criteria

- Male or female patient aged between 18 to 70 years inclusive
- Patient diagnosed with a minimum of 2 non-infected DU fracture (see definition on page 21 of the clinical study protocol) affecting one or more long bones (femur, tibia, fibula, humerus, ulna, radius) documented by an X-Ray and/or a CT-scan showing delayed healing as judged by the investigator.
- Modified Radiographic Union Scale (mRUS) absolute score at screening visit lower than 10 for at least 2 DU fracture sites.
- Global Disease Evaluaton Score as assessed by the patient of 20 mm or higher on Visual Analogue Scale
- 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 9
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
- 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
- Patients for whom 2 of the DU targeted sites occur on both humerus
- Osteosynthesis material revision or a surgery at the fracture site that can have a significant impact on the delayed union fracture healing, as judged by the Investigator
- Active bone infection (at site)
- Femoral neck fracture, if the femur is the target bone of the study
- 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 pain assessments during the study, as judged by the Investigator

Current or previous diagnoses, signs and/or symptoms
- Positive serology for HIV (defined as positive Anti-HIV 1 and/or 2 and/or positive PCR)
- Active hepatitis B (defined as positive HBs Ag and/or positive PCR)
- Active hepatitis C (defined as positive Anti-HCV and/or positive PCR)
- Global sepsis
- 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%)
- Known Allergy to gentamicin
- History of hypersensitivity to human biological material including blood and blood derived products, documented clinically by laboratory tests
- Current or past history of solid or haematological neoplasia
-History of organ 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
- 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 within 1 month of screening) treatment with calcitonin, raloxifen, teriparatide, and/or strontium ralenate
- Current (or within 6 months of screening) illicit drug abuse (as per local law)

Safety aspects concerning female subjects of childbearing potential
- Pregnancy
- Breast-feeding
- Woman with childbearing potential not willing or able to use or present:
- Reliable contraceptive method for at least 6 weeks prior to screening and during the whole study period. Reliable contraceptive methods include orally administered hormonal contraceptives, surgical intervention (e.g., tubal ligation), and intrauterine device (IUD).
- Present negative Urine Pregnancy tests at Visit #1. If a Urine Pregnancy test is positive, the patient is excluded from the study.

Other exclusion criteria
- Body Mass Index (BMI) of 35 kg/m2 or greater
- Unable to undergo general anaesthesia or a surgical intervention

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method

Secondary Outcome Measures

Name	Time	Method

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