IRCT20211021052828N3招募中1 期
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
Rasht University of Medical Sciences0 个研究点目标入组 10 人开始时间: 待定最近更新:
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 10
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 years 至 60 years（—）
- 性别
- All
入选标准
- •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
排除标准
- •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/
研究者
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