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
• Status: Recruiting
• Phase: Early Phase 1
• 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
• 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

Related Conditions & MeSH terms

• Ligament Rupture
• Rupture

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