Effectiveness and Safety of Synovial Tissue and Fat Pad Stromal Vascular Fraction Bioengineering in Patients With Knee Articular Cartilage Injury, Clinical Study Phase I/II
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 入组人数
- 10
- 主要终点
- Cartilage Repair
研究概览
简要总结
A phase I/II clinical trial (first in human) to assess the effectiveness and safety of the treatment of cartilage injury with a tissue engineering construct composed of stromal vascular fraction collected from the synovial membrane and infrapatellar fat of the injured knee, submitted to enzymatic processing in a single surgical time, associated with a collagen scaffold.
The primary outcomes will be assessed by 3T magnetic resonance imaging, quality of life and knee function questionnaires, in addition to perioperative and post-operative complications. Secondary outcomes will be evaluated by measuring the health resources used to ensure compatibility, reproducibility and generalizability of the technique.
The authors believe that adverse events will be similar to current surgical procedures and that there will be an improvement in knee function scores and quality of life of patients undergoing the procedure.
详细描述
Introduction: Cartilage injuries affect up to 63% of the population, and can cause pain and important functional limitations. The evolution to osteoarthritis can lead to a worsening of quality of life, in addition to being highly disabling. Osteoarthritis is considered a public healthcare disease with a high economic and social burden without definitive treatment. Despite the various techniques available today, complete regeneration of damaged hyaline cartilage is not possible. For these reasons, cell therapy with mesenchymal cells has received more attention in research due to the relative ease of processing. Synovia and infra-patellar fat-pad are predictable and easily accessible sources during routine arthroscopic procedure, in addition to exhibiting the greatest potential for chondrogenic differentiation between mesenchymal cell donor sites. In a previous pre-clinical translational study (FAPESP - State of São Paulo Government Research Sponsor Agency), The authors' group developed the tissue bioengineering protocol in a large animal model according to the good laboratory practices for in human usage techniques (GMP). After completing this step, The authors now propose the phase I/II clinical trial.
Purpose: The aim of the study is to evaluate effectiveness and safety for the treatment of articular cartilage injuries, with a compound of stromal vascular fraction acquired from the synovia and infrapatellar fat pad of the knee, associated with a collagen scaffold.
Methods: A phase I/II clinical trial (first in human) to assess the safety and efficacy of the treatment of cartilage injury with a tissue engineering construct.
Inclusion criteria: Patients diagnosed with a single, 3 to 6 cm2 full-thickness cartilage lesion, symptomatic and without improvement with non-operative treatment. Age between 18 and 40 years.
Exclusion criteria: any previous surgery to treat the injury, presence of pathology in the contralateral knee or other pathologies that interfere with recovery. Serological tests will be performed for autologous donors, complete serology: HIV, hepatitis C virus, hepatitis B, human T-lymphotropic virus, syphilis and Chagas.
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 40 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients diagnosed with a single, 3 to 6 cm2 full-thickness cartilage lesion, symptomatic and without improvement with non-operative treatment.
排除标准
- •Any previous surgery to treat the injury, presence of pathology in the contralateral knee or other pathologies that interfere with recovery. Serological tests will be performed for autologous donors, complete serology: HIV, HCV, HBsAg, anti HBC, HTLV I and II, syphilis and Chagas.
结局指标
主要结局
Cartilage Repair
时间窗: The primary outcomes will be assessed preoperatively in the allocation date; at 6 months postoperatively; and at 12 months postoperatively
3T magnetic resonance imaging to evalate quantity and quality of cartilage repair
Visual Analog Score for pain
时间窗: The primary outcomes will be assessed preoperatively in the allocation date; at 6 months postoperatively; and at 12 months postoperatively
A patient is asked to indicate his/her perceived pain intensity (most commonly) along a 100 mm horizontal line, and this rating is then measured from the left edge.
International Knee Documentation Committee Questionnaire
时间窗: The primary outcomes will be assessed preoperatively in the allocation date; at 6 months postoperatively; and at 12 months postoperatively
The questionnaire looks at 3 categories: symptoms, sports activity, and knee function. The symptoms subscale helps to evaluate things such as pain, stiffness, swelling and giving-way of the knee
Western Ontario and McMaster Universities Osteoarthritis Index
时间窗: The primary outcomes will be assessed preoperatively in the allocation date; at 6 months postoperatively; and at 12 months postoperatively
WOMAC evaluates the condition of patients with osteoarthritis of the knee, including pain, stiffness, and physical functioning of the join
Perioperative and post-operative complications
时间窗: Since hospital admission for the procure until hospital discharge; and monthly after discharge, until 12 months postoperatively
Assessment of wound infections, pneumonia, cardiovascular and cerebrovascular events, deep vein thrombosis and/or pulmonary embolisms, ICU-admission, hospital readmission and need for complication surgery
次要结局
- Measurement of health resources expenses(Since allocation date; until 12 months postoperatively)