Effectiveness and Safety of Intraarticular Administration of Autologous Adipose-Derived Regenerative Cells for Treatment of Anterior Cruciate Ligament Partial Rupture
试验速览
- 阶段
- 1 期
- 发起方
- 入组人数
- 12
- 试验地点
- 2
- 主要终点
- Number of serious adverse events (SAEs) and serious adverse reactions (SARs)
研究概览
简要总结
Autologous adipose-derived regenerative cells (ADRC) will be extracted using Celution 800/CRS System (Cytori Therapeutics Inc) from a portion of the fat harvested from the patient's front abdominal wall. Patients will undergo knee arthroscopic surgery followed by one-time intraarticular ADRC administration (directly into anterior cruciate ligament). This is a single arm study with no control. All patients receive cell therapy.
详细描述
Patients with verified diagnosis partial rupture of anterior cruciate ligament will undergo liposuction from front abdominal wall under local anesthesia. After that autologous ADRC will be extracted using Celution 800/CRS System (Cytori Therapeutics Inc) from harvested adipose tissue. Same day patients will undergo knee arthroscopic surgery followed by one-time intraarticular freshly isolated ADRC administration (directly into anterior cruciate ligament close to the rupture).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient suffers from partial rupture of anterior cruciate ligament (confirmed by MRI or knee arthroscopic surgery)
- •Clinically significant knee instability (positive anterior drawer test, pivot shift test, and Lachman test)
- •Patient is familiar with Participant information sheet
- •Patient signed informed consent form
- •Non-inclusion Criteria:
- •Knee osteoarthritis grade III and grade IV
- •Medical history of autoimmune diseases
- •Patients prescribed for immunosuppressive treatment
- •Contraindications to the general or local anesthesia or medical history of allergic reactions to anesthetics
- •Subcompensated or decompensated forms of chronic diseases of internal organs
- •Significant weight loss (> 10% of body weight in the previous year) of unknown etiology
- •Medical history of venous thromboembolism or estimated high risk of venous thromboembolism
- •Clinically significant abnormalities in results of laboratory tests
- •Any conditions limiting compliance (dementia, neuropsychiatric disease, drug and alcohol abuse etc.)
- •Participation in other clinical trials (or administration of investigational drugs) during 3 months prior inclusion
- •Patients with malignant tumors including postoperative period, patients receiving chemotherapy and/or radiotherapy.
- •Patient's activated partial thromboplastin time exceeds normal levels more than 1,8 times
- •Patients prescribed for anticoagulants treatment or patient received anticoagulants at least one hour prior lipoaspiration
- •Medical history of heterotopic ossifications
- •Patients prescribed for glycoprotein inhibitors treatment
排除标准
- •Patient's refusal from the further participation in trial
- •Patient's refusal from compliance with the requirements of contraception during the participation in research
- •Chronic kidney disease IV - V stages (creatinine clearance < 30 mL/min estimated by Cockroft-Gault formula)
- •Confirmed syphilis, HIV, hepatitis B or C infections
- •Dropout Criteria:
- •Complete anterior cruciate ligament rupture confirmed by knee arthroscopic surgery
- •Pregnancy
研究组 & 干预措施
ADRC injection
Subjects will undergo liposuction under local anesthesia. Lipoaspirate will be processed to isolate and concentrate adipose-derived regenerative cells (ADRC). After ADRC isolation autologous cells suspension will be injected intraarticularly into anterior cruciated ligament.
干预措施: Intraarticular administration of autologous ADRC (Other)
ADRC injection
Subjects will undergo liposuction under local anesthesia. Lipoaspirate will be processed to isolate and concentrate adipose-derived regenerative cells (ADRC). After ADRC isolation autologous cells suspension will be injected intraarticularly into anterior cruciated ligament.
干预措施: Liposuction (Procedure)
ADRC injection
Subjects will undergo liposuction under local anesthesia. Lipoaspirate will be processed to isolate and concentrate adipose-derived regenerative cells (ADRC). After ADRC isolation autologous cells suspension will be injected intraarticularly into anterior cruciated ligament.
干预措施: ADRC isolation (Device)
ADRC injection
Subjects will undergo liposuction under local anesthesia. Lipoaspirate will be processed to isolate and concentrate adipose-derived regenerative cells (ADRC). After ADRC isolation autologous cells suspension will be injected intraarticularly into anterior cruciated ligament.
干预措施: Arthroscopic surgery (Procedure)
结局指标
主要结局
Number of serious adverse events (SAEs) and serious adverse reactions (SARs)
时间窗: 2 weeks after treatment
次要结局
- Knee pain intensity monitoring(Follow up to completion (up to 24 weeks after treatment))
- Quality of life monitoring(Follow up to completion (up to 24 weeks after treatment))
- Changes in knee function(Follow up to completion (up to 24 weeks after treatment))
- Changes in knee joint structures(Follow up to completion (up to 24 weeks after treatment))