A Pilot Phase IIa, Multicentre, Open, Proof-of-concept Study on the Safety and the Efficacy of Allogeneic Osteoblastic Cells (ALLOB®) implantation in Lumbar Spinal Fusio

Phase 1

• Conditions: Degenerative disc disease; MedDRA version: 20.0Level: LLTClassification code 10070241Term: Degenerative disc diseaseSystem Organ Class: 100000018941; Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

• Registration Number: EUCTR2013-004480-31-BE
• Lead Sponsor: Bone Therapeutics S.A.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2014-03-21
• Last Update Posted: 5 April 2021

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 32

Inclusion Criteria

- Man or woman aged 18 to 75 years (inclusive)
- Diagnosed with lumbar degenerative disc disease
- Symptomatic with an ODI 2.1a score = 30
- Demonstrated radiologically
- Requiring a single level lumbar fusion (L1 to S1)
- Unresponsive to non-operative treatment (e.g., medication, physical therapy) for at least 6 months at the time of screening
- Capable to provide a written, dated, and signed informed consent and to understand and comply with the study requirements

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 24
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 8

Exclusion Criteria

Current symptoms and/or signs related to the disease under study
- More than one previous spinal surgery at the involved lumbar level
- Previous failed fusion at the involved lumbar level
- Local active or latent infection at the involved lumbar level
- Requiring surgery at more than one-level of the lumbar spinal region within the next 12 months
- Diagnosis of non-union, fracture or tumour at the involved lumbar level
- Diagnosis of multilevel scoliosis or adjacent segment syndrome at the lumbar spine
- Diagnosis of high-grade isthmic/lytic spondylolisthesis (grade > III) requiring multi-level lumbar fusion

Current or previous diagnoses, signs and/or symptoms
- Highly communicable diseases (i.e., HIV, active hepatitis B or C (defined as positive HBs Ag and/or positive PCR), active tuberculosis, syphilis)
- Global sepsis
- Severe renal (defined as a creatinine clearance value < 30 ml/min, calculated with the Cockcroft-Gault formula) or hepatic impairment (defined as alanine aminotransferase or aspartate aminotransferase = 3 times the upper normal limit)
- Severe diabetes (defined as HbA1C > 8%)
- Severe allergy or anaphylaxis
- Known allergy to gentamicin
- Medical condition that can inhibit bone healing (e.g., severe osteoporosis (as defined by T-score <-3 or presence of 2 or more fractures), Paget’s disease, osteomalacia)
- Medical condition that could interfere with study participant assessment (e.g., neuromuscular disease, psychiatric disease, paraplegia)
- Active autoimmune disease (e.g., sclerodermia, Sjögren syndrome, lupus)
- Current or past (within 5 years) malignant neoplasia (except non-metastatic thyroid cancer and non-melanoma skin cancer)
- Poor general health or concomitant disease that would place the patient in excessive risk to surgery (i.e., significant circulatory or pulmonary problems, or cardiac disease)
- History of organ or bone marrow transplantation
- History of hypersensitivity to human biological material including blood and blood derived products, documented clinically or by laboratory tests
Current or previous treatment
- Previous treatment with ALLOB®
- Participation (within 3 months of screening) in another clinical study involving a pharmacological agent
- Current or past treatment (within 5 years of screening) for cancer or blood dyscrasia, including but not limited to chemotherapy, radiotherapy, immunotherapy, biotherapy, haematopoietic growth factors and/or anti-angiogenesis treatment
- Current (within 6 months of screening) illicit drug abuse (as per local law)

Safety aspects concerning female subjects with childbearing potential
- Positive Urine Pregnancy test
- Pregnancy
- Breast-feeding
- Woman with childbearing potential not willing or not able to use 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, intrauterine device or surgical intervention (e.g., tubal ligation)

Other exclusion criteria
- Body Mass Index (BMI) = 35 kg/m2
- Clinically relevant abnormal ECG (>6-lead or according to standard of care at the hospital), as judged by the Investigator or any medically qualified member of the study care team
- Unable to undergo general anaesthesia or a surgical intervention

Study & Design

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