Anterior Cruciate Ligament (ACL) Reconstruction With Autologous Fat Pad Derived Mesenchymal Stem Cells
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 15
- 试验地点
- 1
- 主要终点
- Incidence of Treatment-Emergent Adverse Events
研究概览
简要总结
This study is designed as a prospective, open label, single arm pilot clinical study that will establish the safety and efficacy of a single injection of mesenchymal stromal cells in patients. Each subject will receive one intra-articular injection of autologous mesenchymal stromal cells derived from infrapatellar fat pad (FP-MSC) tissue samples collected from the subject during anterior cruciate ligament (ACL) reconstruction surgery.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients 18 years of age or older who are scheduled to undergo anterior cruciate ligament (ACL) reconstruction with bone-to-bone (BTB) patellar tendon autograft with the Principal Investigator (PI).
- •Receiving post-surgery physical therapy at a Houston Methodist physical therapy (PT) clinic.
排除标准
- •Under 18 years of age
- •Prior surgery on affected knee
- •Root repair, inflammatory arthropathy, or any other concomitant procedure that cannot follow an accelerated PT protocol or any concomitant procedure that the PI deems exclusionary
- •Unable to attend physical therapy at Houston Methodist
- •Vulnerable populations
- •Immunocompromised patients such as those being treated for cancer, kidney failure, etc.
- •Heart disease (including systolic blood pressure >180 mm Hg or heart failure)
- •Active infections
- •Non-English-speaking patients
- •Any known metal implants or allergy to contrast agents
- •Pregnancy (as part of standard of care, all female participants will be administered a urine pregnancy test prior to surgery. A negative result is required to proceed with surgery per SOC and thus, participate in the study) and those planning to become pregnant during the duration of the study
- •Any condition with known bleeding disorders, thrombus formation risk factors, or overlying wound and skin infections
- •Any condition in the opinion of the primary investigator that would compromise the integrity of the data collection or outcomes being assessed
- •Any other medical condition that in the opinion of the primary investigator would constitute a relative contraindication to study participation (e.g., Ankylosing spondylitis, psoriatic arthritis, rheumatoid arthritis, SLE, scleroderma, polymyositis, Ehlers-Danlos syndrome, osteoporosis)
研究组 & 干预措施
Intra-articular injection of autologous mesenchymal stromal cells
Each subject will receive one intra-articular injection of autologous mesenchymal stromal cells derived from infrapatellar fat pad (FP-MSC) tissue samples collected from the subject during anterior cruciate ligament (ACL) reconstruction surgery.
干预措施: Autologous Mesenchymal Stromal Cells (Biological)
结局指标
主要结局
Incidence of Treatment-Emergent Adverse Events
时间窗: 4-5 weeks postop, 6-7 weeks postop, 3.5 months postop, 6 months postop
Participants will be asked via a follow-up phone call following injection whether or not they have experienced any adverse events following the injection. They will be assessed at all remaining standard of care follow up visits and staff will inquire about adverse events.
Knee Function
时间窗: Preoperative appointment, 6 weeks postop, 3.5 months postop, 6 months postop
Knee function will be assessed through patient reported responses on the Knee Injury and Osteoarthritis Outcome Score (KOOS) survey via REDCap. The Questionnaire has five subscales which are separately scored (pain, function in daily living, function in sport and recreation, other symptoms and knee-related quality of life). Final score will be determined on a scale of 0-100 where 100 indicates no symptoms and 0 indicates extreme symptoms.
次要结局
- Return to Sport Time(3 months postop)
- Knee Swelling(Preoperative appointment, 6 weeks postop, 3.5 months postop, 6 months postop)
- Knee Pain(Preoperative appointment, 6 weeks postop, 3.5 months postop, 6 months postop)
研究者
Patrick McCulloch,MD
John S. Dunn Chair in Orthopedic Surgery
The Methodist Hospital Research Institute