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IRCT20211021052828N3 IRCT 2023-09-02 Rasht University of Medical Sciences Safety and efficacy of umbilical cord Wharton’s jelly-derived mesenchymal stem cell in patients with lumbar degenerative disc disease Evaluation of the safety of allogeneic human Wharton’s jelly-derived mesenchymal stem cell transplantation in patients with lumbar degenerative disc disease: a phase I clinical trial 2023-09-05 anticipated 10 Complete https://irct.ir/trial/72039 interventional Randomization: N/A, Blinding: Not blinded, Placebo: Not used, Assignment: Single, Purpose: Treatment. 1 Lumbar degenerative disc disease. Intervention group: Intradiscal injection of Wharton's jelly-derived mesenchymal stem cells to 10 patients with lumbar degenerative disc disease. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is There is no further information.
public Elham Vojoudi
Razi University Hospital, Sardare Jangal Blvd.
Rasht Iran (Islamic Republic of) 4144895655 +98 13 3354 2460 elhamvojoodi@yahoo.com Rasht University of Medical Sciences scientific Elham Vojoudi
Razi University Hospital, Sardare Jangal Blvd.
Rasht Iran (Islamic Republic of) 4144895655 +98 13 3354 2460 elhamvojoodi@yahoo.com Razi University Hospital Iran (Islamic Republic of) 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 18 years 60 years Both 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/L M51.1+ Lumbar and other intervertebral disc disorders with radiculopathy Treatment - Other Intervention group: Intradiscal injection of Wharton's jelly-derived mesenchymal stem cells to 10 patients with lumbar degenerative disc disease 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. Improvement in Visual Analogue Scale (VAS) for pain. Timepoint: Baseline and 1, 3, 6, and 12 months after intervention. Method of measurement: According to the patient's report. Improvement in Oswestry Disability Index (ODI). Timepoint: Baseline and 1, 3, 6, and 12 months after intervention. Method of measurement: Questionnaire. Improvement in quality of life. Timepoint: Baseline and 6 and 12 months after intervention. Method of measurement: SF-36 questionnaire. Improvement in disc height index (DHI). Timepoint: Baseline and 6 and 12 months after intervention. Method of measurement: MRI. Changes in the signal intensity of the nucleus pulposus (NP) region. Timepoint: Baseline and 6 and 12 months after intervention. Method of measurement: MRI. Changes in the Pfirrmann grading. Timepoint: Baseline and 6 and 12 months after intervention. Method of measurement: MRI. Assessment of worsening of patients' primary symptoms or performance (will be considered an AE). Timepoint: Up to 1 year. Method of measurement: Clinical examination, questionnaires for pain, disability and quality of life, and paraclinical tests. Rasht University of Medical Sciences Rasht University of Medical Sciences private Approved 2023-08-09 Research Ethics Committees of Guilan University of Medical sciences The old building of the Faculty of Health, in front of 17 Shahrivar Hospital, Namjoo St., Shahid Siadati St. Rasht Guilan Iran (Islamic Republic of)