跳至主要内容
临床试验/NCT03390920
NCT03390920尚未招募不适用

Evaluation of Regenerative Medicine Outcomes With Umbilical Allograft for Musculoskeletal Conditions

R3 Stem Cell2 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2022年1月1日最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
200
试验地点
2
主要终点
Short Musculoskeletal Function Assessment Questionnaire (SMFA)

研究概览

简要总结

The aim of the study is to determine the efficacy of an Amniotic Fluid Tissue Product for pain relief and functional improvements for all types of musculoskeletal conditions. The study is prospective, with outcome measures being obtained at numerous time points after the regenerative procedure.

详细描述

Medical providers are often faced with patients whose source of pain may be the result of an inflammatory response caused by trauma or disease. By managing the patient's inflammation, the clinician may see improved response to traditional pain management therapy and existing protocols.

Also, degenerative arthritis of spinal and extremity joints may lead to significant low back, knee, hip, shoulder pain etc, as the ratio of cartilage degradation to cartilage formation increases with age. An amniotic tissue derived product may prove to be an ideal non-steroidal and potentially regenerative therapy for use by the medical provider due to its unique characteristics.

The orthopedic application of amniotic fluid dates back to at least the 1930's. The placental membranes produce an array of immunosuppressive and anti-inflammatory molecules, which make these tissues suitable for use as a wound covering [or as an anti-inflammatory] in a clinical setting. In addition to structural properties, placental membrane and amniotic fluid (AF) is a rich source of growth factors, including organic compounds and nutrients, hyaluronic acids, amino acids, antioxidants and stem cells.

AF's anti-inflammatory actions may be mediated in part by its secretion of anti-inflammatory cytokines including interleukin-10, inhibin, activin, and interleukin-1 receptor antagonist as well as anti-inflammatory protease inhibitors such as ∞-1 anti-trypsin inhibitor and inter-a-trypsin inhibitor. AF may modulate acquired immunity by suppressing alloreactive responses and down regulating production of Th1 and Th2 cytokines.

In addition to having known anti-inflammatory qualities, placental membrane cells, derived from the layer of trophoblast cells covering the developing embryo, do not express MHC Class II antigens, which are responsible for the rapid rejection of allografts in humans. Because AF is immune privileged, it is an ideal allograft with no known graft-versus-host disease (GVHD).

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

入选标准

  • Age 18 and over.
  • Ability to attend follow up visits or at least converse on phone or complete email follow up forms.
  • 4) Competent to understand the study protocol and provide voluntary informed consent.

排除标准

  • Active Infection
  • Pregnancy, Lactating
  • Clotting disorder

结局指标

主要结局

Short Musculoskeletal Function Assessment Questionnaire (SMFA)

时间窗: Baseline and then Assess Changes Post Intervention at 4 weeks, 3 mths, 6 mths, 9 mths and one year

The Short Musculoskeletal Function Assessment Questionnaire (SMFA) is designed to measure the functional status of patients with a broad range of musculoskeletal injuries and disorders.

次要结局

  • Work Status(Baseline and then Assess Changes Post Intervention at 4 weeks, 3 mths, 6 mths, 9 mths and one year)
  • Visual Analog Scale (VAS)(Baseline and then Assess Changes Post Intervention at 4 weeks, 3 mths, 6 mths, 9 mths and one year)

研究者

发起方
R3 Stem Cell
申办方类型
Industry
责任方
Sponsor

研究点 (2)

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