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NCT04889963 Clinical Trial

Regeneration of Posterior Cruciate Ligament Injury Using Hypoxic Conditioned Allogenic Adipose Mesenchymal Stem Cell and Condition Medium

Ligament Rupture Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT04889963
Other study ID # STEMCELL-LIGAMENTREGENERATION
Secondary ID
Status Recruiting
Phase Early Phase 1
First received
Last updated
Start date January 1, 2021
Est. completion date June 30, 2021

Study information
Verified date May 2021
Source Gadjah Mada University
Contact sholahuddin rhatomy, MD
Phone +62 274 588688
Email rhatomy.s@gmail.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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

Description:

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

Recruitment information / eligibility
Status Recruiting
Enrollment 16
Est. completion date June 30, 2021
Est. primary completion date June 30, 2021
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Male
Age group 2 Months to 12 Months
Eligibility Inclusion Criteria: - white male new zealand rabbit - weight 2500 - 3000 gram Exclusion Criteria: - have no disease

Study Design

Related Conditions & MeSH terms

Intervention

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

Locations
Country Name City State
Indonesia Sholahuddin Rhatomy Sleman Yogyakarta

Sponsors (1)
Lead Sponsor Collaborator
Gadjah Mada University

Country where clinical trial is conducted

Indonesia, 

Outcome
Type Measure Description Time frame Safety issue
Primary tensile strength of posterior cruciate ligament measurement of tensile strength of posterior cruciate ligament 6 weeks
Primary Thrombosite of Growth Factor - beta 1 measurement value of Thrombosite Growth Factor - beta 1 6 weeks
Primary basic fibroblast of growth factor measurement value of basic fibroblast of growth factor 6 weeks
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