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临床试验/NCT05264922
NCT05264922撤回2 期

Stromal Vascular Fraction (SVF) Cells for Non-Operative Treatment of Small Rotator Cuff Tears

AdventHealth1 个研究点 分布在 1 个国家开始时间: 2022年1月9日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
2 期
状态
撤回
发起方
AdventHealth
试验地点
1
主要终点
Primary Efficacy - MRI-measured healing rate in the rotator cuff tear

研究概览

简要总结

The investigator's goal is to determine the effectiveness of stromal vascular fraction (SVF) cell injection to treat small rotator cuff tears without surgery.

详细描述

Small rotator cuff tendon tears are a hard task in shoulder care. They are often not operated on because research has not shown any increased benefit of surgery over physical therapy. The most common way to treat these tears is through physical therapy or steroid injections. However, the relief doesn't last very long. Recent studies have shown a lot of tears get worse over time. This happens because the physical therapy options can treat the pain and symptoms, but do not heal the actual tear.

Another non-surgical option for treating small tears is through adipose-derived stem cells. Adipose-derived stem cells are cells that are found in the fat in our bodies. The cells have shown promise in fixing tissues and may provide help to treat small rotator cuff tears. The investigators are studying a part of these fat cells known as the stromal vascular fraction (SVF). The SVF contains a number of cells that are able to become a variety of different cells. This is important because they may be able to turn into cells that may help heal the damaged rotator cuff tendons. These cells have been shown to improve results after rotator cuff surgery, but no research has used these cells to help small tears without surgery. The use of SVF is investigational. "Investigational" means that the drug being tested has not been approved for routine clinical use or for the use described in this study by the United States Food and Drug Administration (FDA). The FDA is allowing the use of this drug for research. The investigators goal is to determine the effectiveness of SVF cell injection to treat small rotator cuff tears without surgery.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Triple (Participant, Care Provider, Outcomes Assessor)

盲法说明

The provider (PI) and team performing the injection will not care for the subject during follow up.

入排标准

年龄范围
30 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 未提供

研究组 & 干预措施

Fibrin Glue

Active Comparator

Single 4 milliliter (mL) injection of 0.9% normal saline and fibrin glue solution

干预措施: Tisseel Injectable Product (Drug)

SVF cells and Fibrin Glue

Experimental

Nucleated adipose-derived cells loaded in a fibrin glue scaffold

干预措施: Tisseel Injectable Product (Drug)

SVF cells and Fibrin Glue

Experimental

Nucleated adipose-derived cells loaded in a fibrin glue scaffold

干预措施: Stromal Vascular Fraction Cells (Biological)

结局指标

主要结局

Primary Efficacy - MRI-measured healing rate in the rotator cuff tear

时间窗: 24 months

Healing rates between the treatment with stromal vascular fraction (SVF) cells and exercise program (EP) group will be compared to the sham and EP group.

Primary Safety - Incidence/Rates of adverse events (AEs) involving the affected joint

时间窗: 24 months

Both study-related AE assessments and the clinical record will be interrogated to determine if the subjects had any adverse events involving the affected joint. Incidence and rates of AEs between the treatment with stromal vascular fraction (SVF) cells and exercise program (EP) group will be compared to the sham and EP group.

次要结局

  • Patient-reported measures Western Ontario Rotator Cuff (WORC) Index(24 months)
  • Patient-reported measures Patient Reported Outcomes Measurement Information System (PROMIS)(24 months)
  • Patient-reported measures Visual Analog Scale (VAS)(24 months)

研究者

发起方
AdventHealth
申办方类型
Other
责任方
Sponsor

研究点 (1)

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