2024-517684-23-00招募中2 期
Phase I/IIa study to test the safety and efficacy of MSC from umbilical cord tissue (UC-MSC) for the treatment of cartilage damage in the knee joint - BP CC 001
BIONCaRT GmbH7 个研究点 分布在 1 个国家目标入组 55 人开始时间: 2025年4月24日最近更新:
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 55
- 试验地点
- 7
- 主要终点
- Proportion of patients with a serious adverse event within 24 months after surgery
研究概览
简要总结
Evaluation of the safety of the investigational product BP CC 001 (10 x 106 UC-MSC in 1 ml cell culture suspension) applied to a collagen support structure (Chondro-Gide®)
入排标准
- 年龄范围
- 18 years 至 64 years（18-64 Years）
- 接受健康志愿者
- 是
入选标准
- •Patients of any gender with an age of ≥ 18 years to ≤ 60 years
- •Symptomatic grade III/IV cartilage defect according to ICRS or osteochondral defect with a maximum depth of 3 mm
- •A cartilage defect requiring treatment with a defect size of 2 - 6 cm² on the femoral condyles or patella or trochlea
- •Affected and contralateral knee (if known): Kellgren-Lawrence (K/L) osteoarthritis severity < grade III
- •KOOS pain sub-score of ≤ 70 (out of max. 100) in the affected knee joint and > 80 (out of max. 100) in the contralateral knee joint measured without taking analgesics within the last 24 hours
- •BMI < 35 kg/m²
- •Written informed consent
排除标准
- •Known varus or valgus malalignment of the affected leg of ≥ 5°
- •Previous fracture in the affected knee joint
- •Osteoporosis
- •Relevant concomitant diseases that increase the risk of surgery, e.g. heart failure, coronary heart disease, coagulation disorders, diabetes mellitus, liver cirrhosis, renal insufficiency, etc.
- •History of hypersensitivity to porcine collagens, human albumin, glucose or components of fibrin adhesives used in orthopaedics or surgery
- •Simultaneous participation in another interventional clinical trial (incl. within the last 4 weeks before inclusion)
- •Addictions or other illnesses that do not allow the person con-cerned to assess the nature and extent of the clinical trial and its possible consequences
- •Any state that excludes adherence with the trial protocol (e.g. lack of compliance)
- •Persons who are placed in an institution by court or official order
- •Persons dependent on the sponsor
- •Pregnant or breastfeeding women
- •Antero-posterior or medio-lateral instability
- •Women of childbearing potential, except women who meet one of the following criteria: a) post-menopausal (12 months natural amenorrhoea) b) postoperative (6 weeks after bilateral ovarectomy with or with-out hysterectomy, bilateral salpingectomy) c) negative pregnancy test (urine) and regular and correct use of a contraceptive method with an Pearl Index < 1% per year - Combined (oestrogen and progestogen-containing) hormonal contraception - Hormonal contraception containing progestogens (oral, injected, implanted) - IUD (hormonal IUD, copper IUD) d) sexual abstinance e) vasectomy of the partner
- •Meniscus loss of more than 20% in the affected compartment
- •Patella instability
- •Simultaneous surgery on other joint structures (cruciate ligament replacement, meniscus suture, partial meniscus resection > 20%, osteotomy)
- •Simultaneous higher-grade (ICRS grade III/IV) cartilage damage on the corresponding joint surfaces to the treated cartilage damage
- •Intra-articular application of hyaluronic acid or glucocorticoids or thrombocyte concentrates within the last 6 months
- •Joint replacement in the contra-lateral knee or hip within the last 12 months
- •Rheumatoid arthritis or other inflammatory diseases such as autoimmune diseases, seronegative spondyloarthritis, gout, pseudogout
结局指标
主要结局
Proportion of patients with a serious adverse event within 24 months after surgery
Proportion of patients with a serious adverse event within 24 months after surgery
次要结局
- Regeneration of damaged cartilage measured by MOCART score (relative change in the value 12 months after surgery compared to the initial value before surgery)
- Relative change in knee joint pain 12 and 24 months after the surgery compared to the baseline value before the surgery measured using the KOOS Pain Subscore
- Relative change in knee-related quality of life 12 and 24 months after surgery compared to baseline before surgery measured by KOOS-QoL subscore
- Relative change in symptoms and stiffness 12 and 24 months after surgery compared to pre-surgery baseline as measured by KOOS symptom subscore
- Relative change in activities of daily life 12 and 24 months after surgery compared to baseline before surgery measured by KOOS-ADL subscore
- Relative change in physical resilience during sporting activities 12 and 24 months after the surgery compared to the baseline value before the surgery measured by KOOS-Excercise /Rec-Subscore
- AE, AR, SAE, SAR, SUSAR: Description of all adverse events (AE, AR, SAE, SAR, SUSAR) within 24 months after surgery in terms of severity (assessed according to National Cancer Institute - Common Terminology Criteria for Adverse Events Version 5.0 (NCI-CTCAE V 5.0)), causality, outcome
研究者
Dr. André Gerth
Scientific
BIONCaRT GmbH
研究点 (7)
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