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临床试验/NCT04889963
NCT04889963Unknown早期 1 期

Regeneration of Posterior Cruciate Ligament Injury Using Hypoxia Conditioned Allogenic Adipose Mesenchymal Stem Cell (AdMSC) and Ligament Derived Condition Medium (Secretome)

Gadjah Mada University1 个研究点 分布在 1 个国家目标入组 16 人开始时间: 2021年1月1日最近更新:
适应症
干预措施

试验速览

阶段
早期 1 期
发起方
入组人数
16
试验地点
1
主要终点
Thrombosite of Growth Factor - beta 1

研究概览

简要总结

Transplantation of Allogenic Adipose Mesenchimal Stem cell in hypoxic cultur condition with Ligament- derived conitioned medium can enhance regeneration of posterior cruciate ligament rupture

详细描述

this study is in vivo study to prove effect of transplantation of Allogenic Adipose Mesenchimal Stem cell in hypoxic cultur condition with Ligament- derived conitioned medium in regeneration of posterior cruciate ligament rupture

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Basic Science
盲法
None

入排标准

年龄范围
2 Months 至 12 Months(Child)
性别
Male
接受健康志愿者
是

入选标准

  • •white male new zealand rabbit
  • •weight 2500 - 3000 gram

排除标准

  • •have no disease

研究组 & 干预措施

control group

Placebo Comparator

rabbit with posterior cruciate ligament rupture and treated with fibrin glue (sacffold)

干预措施: adypose mesenchymal conditioned medium and ligament derived conditioned medium (Biological)

conditioned medium group

Active Comparator

rabbit with posterior cruciate ligament rupture and treated with fibrin glue mix with ligament derived conditioned medium

干预措施: adypose mesenchymal conditioned medium and ligament derived conditioned medium (Biological)

stem cells group

Active Comparator

rabbit with posterior cruciate ligament rupture and treated with fibrin glue mix with adypose mesenchymal stem cells in hypoxic culture condition

干预措施: adypose mesenchymal conditioned medium and ligament derived conditioned medium (Biological)

composite group

Experimental

rabbit with posterior cruciate ligament rupture and treated with fibrin glue mix with adypose mesenchymal stem cells in hypoxic culture condition and ligament derived conditioned medium

干预措施: adypose mesenchymal conditioned medium and ligament derived conditioned medium (Biological)

结局指标

主要结局

Thrombosite of Growth Factor - beta 1

时间窗: 6 weeks

measurement value of Thrombosite Growth Factor - beta 1

basic fibroblast of growth factor

时间窗: 6 weeks

measurement value of basic fibroblast of growth factor

tensile strength of posterior cruciate ligament

时间窗: 6 weeks

measurement of tensile strength of posterior cruciate ligament

次要结局

未报告次要终点

研究者

发起方
Gadjah Mada University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Sholahuddin Rhatomy

Director, Head of Orthopaedic Department,faculty of medicine,public health and nursing,universitas gadjah mada, Sholahuddin Rhatomy,MD

Gadjah Mada University

研究点 (1)

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