Safety and efficacy of umbilical cord Wharton’s jelly-derived mesenchymal stem cell in patients with lumbar degenerative disc disease

Phase 1

Recruiting

• Conditions: umbar degenerative disc disease.; Lumbar and other intervertebral disc disorders with radiculopathy; M51.1+

• Registration Number: IRCT20211021052828N3
• Lead Sponsor: Rasht University of Medical Sciences

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 16 October 2023

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 10

Inclusion Criteria

Male or females between 18 and 60 years of age
Degenerative disease of one or two lumbar discs with predominant back pain after conservative treatment (physical and medical) for over 6 months
Patients with back pain and radicular pain
Fibrous ring capable of holding the cell implantation, demonstrated by RMI image (stages 2, 3 and 4 of Adams)
Decrease of disc height of more than 20% compared to the adjacent normal disc based on radiographic evaluation
Absence of spinal infection
Pfirrmann grade III-IV
The patient has the ability to understand the requirements of the study, to provide written informed consent, and to comply with the study protocol
In fertile women with a negative pregnancy test result and acceptance of appropriate methods of contraception
Lumbar degenerative disc disease with posterior bulging disc confirmed on MRI
Pre-treatment baseline low back pain of at least 40 mm on a 100 mm visual analog scale
Pre-treatment baseline Oswestry Disability Index Questionnaire score of at least 30 on the 100-point questionnaire
No previous history of spine surgery
No history of metabolic, autoimmune (e.g., rheumatoid arthritis) and genetic disease

Exclusion Criteria

Allergy to bovine serum, penicillin or dimethyl sulfoxide (DMSO)
Rejection of surgical treatment
Congenital or acquired diseases leading to spine deformations that may upset cell application
Spinal segmental instability, spinal canal stenosis, isthmus pathology and other conditions that may compromise the study
Modic III changes on MRI images
Overweight with body mass index (BMI) greater than 35
Pregnant or lactating women, or women planning to become pregnant during the first year (12 months) following cell injection
Current or previous history of neoplasm in the last 3 years (excluding basal cell carcinoma)
Immunosuppressive therapy and corticosteroids
Systemic inflammatory disease (spondylitis, rheumatoid arthritis, etc.)
Psychosis and severe personality disorder
Potentially active neurological disorder associated with symptoms (e.g., peripheral neuropathy)
History or current evidence of alcohol or drug abuse or recreational use of illicit drugs or prescription medications
High surgical risk (ASA> IV), or contraindication to anesthesia
Previous chemotherapy
Uncontrolled hypertension despite receiving optimal medication
A patient who has received a lumbar epidural steroid injection within 3 weeks prior to cell injection
History of receiving stem/progenitor cell therapy or other biological interventions to repair the target intervertebral disc
Participation in another clinical trial or treatment with another investigational product within 30 days prior to inclusion in the study
Severe coagulation disorders or use of oral anticoagulants
Contraindications to MRI (history of implantation of cardiovascular and cerebrovascular stents, pacemakers, etc.)
Patients who are at risk of surgery in the next 6 months
An acute fracture of the spine at the time of enrollment in the study
Signs of infection or positive serology for HIV, hepatitis, CMV, or syphilis
Recent history of smoking
Subjects with severe osteoporosis (with an average T-score of -2.5 or below in the lumbar bone density test)
Serious pre-existing medical conditions such as cardiovascular disease, renal disease, liver disease, endocrine disease, cancer, and diabetes mellitus
Abnormal blood tests: hepatic (alanine aminotransferase [ALT] and/or aspartate aminotransferase [AST] >1.5 × upper limit of normal [ULN]), anemia or platelet count of <100 × 109/

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Safety and tolerability assessment. Timepoint: Up to 1 year. Method of measurement: Clinical examination, questionnaire, and blood tests.;Physical examinations, side effects of treatment, and paraclinical test results (such as CBC count, ESR, CRP, and MRI). Timepoint: Baseline and 1, 3, 6, and 12 months after intervention. Method of measurement: Clinical examination, questionnaires for pain, disability and quality of life, and paraclinical tests.