Effect of Autologous Cartilage Micrografting in Knee Cartilage Disease
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 33
- 试验地点
- 1
- 主要终点
- Change in Knee Osteoarthritis Outcome Score (KOOS)
研究概览
简要总结
The goal of this clinical trial is to learn if a single injection of autologous cartilage micrografts suspension, obtained through processing with a specialized technology patient's own small piece of ear cartilage, can improve knee osteoarthritis in adult men and women aged 18-75 with confirmed moderate knee osteoarthritis. The main questions it aims to answer are:
- Does a single intra-articular injection of autologous ear-cartilage micrografts improve patients' clinical symptoms and knee function over 12 months?
- What percentage of patients experience improvement in their complaints following treatment?
- Do MRI scans show measurable improvement in knee cartilage condition 6 months after treatment?
- Do inflammatory cytokine levels (IL-1β, IL-1α, IL-6, TNF-α) in joint fluid and cartilage tissue correlate with treatment response?
详细描述
Background and Rationale Knee osteoarthritis is among the most common orthopedic conditions, affecting an estimated 10-12% of the population. Left untreated, it tends to progress, leading to worsening degenerative joint changes and functional loss. Treatment remains difficult because articular cartilage has very limited natural regenerative capacity. Currently used approaches - arthroscopic debridement, radiofrequency chondroplasty, and hyaluronic acid injection - have inconsistent or unsatisfactory efficacy.
This study reproduces a previously published treatment procedure using autologous cartilage micrografts sourced from the patient's own auricular (ear) cartilage, rather than from the knee joint itself or from cultured chondrocytes. Ear cartilage was selected as the donor tissue for three reasons: (1) elastic auricular cartilage has physical and biological properties closer to the hyaline cartilage found in the knee joint than other readily accessible cartilage sources; (2) the sampling procedure is simple and minimally invasive compared to harvesting from a weight-bearing joint; and (3) the perichondrial tissue surrounding ear cartilage contains a high density of chondroprogenitor cells responsible for regenerative processes.
Study Design The research has two components conducted on the same patient cohort: a clinical component evaluating the treatment's effect on patients' symptoms and joint imaging, and a laboratory component measuring inflammatory cytokine concentrations in tissue and joint fluid samples collected during the same procedure. This is a single-arm interventional study; there is no placebo or active comparator, and no randomization or blinding, since every enrolled participant receives the identical intervention on one knee affected by osteoarthritis.
Procedure
Each participant is treated on a single, affected knee. The procedure begins with drainage and storage of synovial fluid from the affected knee, for two reasons: synovial fluid in patients with knee osteoarthritis is expected to carry a high concentration of inflammatory cytokines that may impede improvement or contribute to discomfort, and removing it prevents dilution of the cartilage micrograft suspension subsequently injected.
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
- •Diagnosed knee OA L-K grade II-III
- •Symptomatic knee OA (with pain)
- •Reduced mobility
排除标准
- •Knee OA L-K grade IV
- •Systemic Joint Disease (e.g. rheumatoid arthritis)
- •Active autoimmune disease
- •Active Oncologic process
- •If other orthobiologic treatments administered in the last 3 months
研究组 & 干预措施
Intervention Group
Autologous Cartilage Micrografting is performed to all subjects with moderate knee osteoarthritis
干预措施: Mytocel MSK - Autologous Ear Cartilage Micrografting (Device)
结局指标
主要结局
Change in Knee Osteoarthritis Outcome Score (KOOS)
时间窗: Baseline, 1 week, 3 months, 6 months, 12 months, and 24 months
Change from baseline in KOOS subscale scores (including Pain and Symptoms/Stiffness), scored 0-100 with higher scores indicating better knee-related quality of life and function. Assessed via repeated-measures analysis across follow-up visits relative to baseline
次要结局
- Change in knee cartilage thickness on MRI(Baseline, 6 months)
- Baseline synovial fluid and cartilage tissue cytokine concentrations(Time of the procedure)