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

May 14, 2021 updated by: Sholahuddin Rhatomy, Gadjah Mada University

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

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed 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

Study Type

Interventional

Enrollment (Anticipated)

16

Phase

  • Early Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Indonesia
    • Yogyakarta
      • Sleman, Yogyakarta, Indonesia, 55571
        • Recruiting
        • Sholahuddin Rhatomy
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

2 months to 1 year (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • have no disease

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: control group
rabbit with posterior cruciate ligament rupture and treated with fibrin glue (sacffold)
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
Active Comparator: conditioned medium group
rabbit with posterior cruciate ligament rupture and treated with fibrin glue mix with ligament derived conditioned medium
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
Active Comparator: stem cells group
rabbit with posterior cruciate ligament rupture and treated with fibrin glue mix with adypose mesenchymal stem cells in hypoxic culture condition
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
Experimental: composite group
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
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
tensile strength of posterior cruciate ligament
Time Frame: 6 weeks
measurement of tensile strength of posterior cruciate ligament
6 weeks
Thrombosite of Growth Factor - beta 1
Time Frame: 6 weeks
measurement value of Thrombosite Growth Factor - beta 1
6 weeks
basic fibroblast of growth factor
Time Frame: 6 weeks
measurement value of basic fibroblast of growth factor
6 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Gadjah Mada University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2021

Primary Completion (Anticipated)

June 30, 2021

Study Completion (Anticipated)

June 30, 2021

Study Registration Dates

First Submitted

May 9, 2021

First Submitted That Met QC Criteria

May 14, 2021

First Posted (Actual)

May 17, 2021

Study Record Updates

Last Update Posted (Actual)

May 17, 2021

Last Update Submitted That Met QC Criteria

May 14, 2021

Last Verified

May 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • STEMCELL-LIGAMENTREGENERATION

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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