CTRI/2015/04/005661已完成3 期
A Prospective, Open-label, Multicentric Study to Assess the Safety and Efficacy of Autologous Adult Live Cultured Chondrocytes (CHONDRON®) in Subjects with Articular Cartilage Defects of the Articulating Joint(s).
Regenerative Medical Services Pvt Ltd4 个研究点 分布在 1 个国家目标入组 12 人开始时间: 2015年8月4日最近更新:
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 12
- 试验地点
- 4
- 主要终点
- To assess the safety of the Autologous Adult Live Cultured Chondrocytes (CHONDRON®) implantation in articular cartilage defects of the articulating joint(s).
研究概览
简要总结
This is a Prospective, Open-label, Multicentric Study to Assess the Safety and Efficacy of Autologous Adult Live Cultured Chondrocytes (CHONDRON®) in Subjects with Articular Cartilage Defects of the Articulating Joint(s). Subjects will undergo implantation with CHONDRON® (Autologous Adult Live Cultured Chondrocytes). The Autologous Adult Live Cultured Chondrocytes (CHONDRON®) implantation is a two stage procedure with Stage I as Biopsy sample collection (cartilage harvest) and Stage II as Implantation (Autologous Adult Live Cultured Chondrocytes implantation). At visit 2, tissue sample of approximately 6-8 mm size will be collected by biopsy from the healthy cartilage of articulating joint(s) under study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Not Applicable
- 盲法
- Not Applicable
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Male or female subjects aged 18 to 65 years (both inclusive) with focal, ICRS (grade III or IV) articular cartilage defects on the weight bearing surface of the articulating joint(s).
- •3.Subjects with intact meniscus, stable knee, with normal alignment (corrective procedure may be performed in combination with or prior to biopsy) with a normal joint space with no inflammation or arthritic changes in the joint.
- •4.Subjects reported with bilateral defects shall be included, however only unilateral defect will be treated at a time and not together.
- •5.Subject is willing and able to comply with post-operative weight-bearing restrictions and rehabilitation.
- •6.Body mass index (BMI) <35 kg/m
- •7.Subjects (or legally acceptable representative [LAR] of impartial witness) who are able to provide written informed consent prior to participation in the study.
排除标准
- •1.Subjects with degenerative changes like osteoarthritis and recommended for total knee replacement avascular necrosis and articular cartilage defects with kissing lesions.
- •2.Subjects with tibio-femoral mal-alignment of articulating joints, instability of articulating joint ligament, and/or bone defects around area of defective cartilage.
- •3.Subjects with inflammatory arthritis, such as osteoarthritis and gouty arthritis.
- •4.Subjects with autoimmune disease related rheumatoid arthritis.
- •5.Subjects who are pregnant, breast-feeding or have childbearing potential and have had a positive pregnancy test prior to receiving the therapy.
- •6.Subjects with malignant tumors, who have undergone radiotherapy or chemotherapy within last 2 years.
- •7.Subjects with type 1 or type 2 Diabetes Mellitus having pre-prandial blood glucose levels >130mg/dL and post prandial blood glucose levels >180 mg/dL at screening visit.
- •8.Subjects with acute infections, currently on treatment with antibiotics and antimicrobials will not be included.
- •Such subjects may be considered after completion of adequate treatment and as per Investigator’s discretion.
- •9.Subjects under adrenocorticoid therapy and/or history of alcohol or drug abuse/dependency.
- •10.Subjects with psychiatric disorders who are considered inappropriate to participate in this study by the Principal Investigator.
- •Subjects with Psychiatric disorders who are on stable medication may be included in the study as per Investigator’s discretion.
- •11.History of receiving an investigational product within 30 days prior to enrollment in this study.
- •12.Subjects who are tested positive for HIV, Hepatitis B or Hepatitis C and Syphilis.
- •13.Subjects who are diagnosed with tuberculosis at the time of Screening.
- •14.Subjects who have hemoglobinopathies such as and not limited to sickle cell anemia, leukaemia and thalassemia.
- •15.Subjects who have ongoing history of cardiac, renal and hepatic dysfunctions.
结局指标
主要结局
To assess the safety of the Autologous Adult Live Cultured Chondrocytes (CHONDRON®) implantation in articular cartilage defects of the articulating joint(s).
时间窗: 03 months after implantation
次要结局
- To evaluate the efficacy of Autologous Adult Live Cultured Chondrocytes (CHONDRON®) implantation in articular cartilage defects of the articulating joint(s).(06 months after implantation)
研究者
研究点 (4)
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