Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04889963
Recruitment Status : Recruiting
First Posted : May 17, 2021
Last Update Posted : May 17, 2021
Sponsor:
Information provided by (Responsible Party):
Sholahuddin Rhatomy, Gadjah Mada University

Brief 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

Condition or disease Intervention/treatment Phase
Adypose Mesenchimal Stem Cell Ligament Rupture Ligament Derived Conditined Medium Biological: adypose mesenchymal conditioned medium and ligament derived conditioned medium Early Phase 1

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

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 16 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Regeneration of Posterior Cruciate Ligament Injury Using Hypoxia Conditioned Allogenic Adipose Mesenchymal Stem Cell (AdMSC) and Ligament Derived Condition Medium (Secretome)
Actual Study Start Date : January 1, 2021
Estimated Primary Completion Date : June 30, 2021
Estimated Study Completion Date : June 30, 2021

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




Primary Outcome Measures :
  1. tensile strength of posterior cruciate ligament [ Time Frame: 6 weeks ]
    measurement of tensile strength of posterior cruciate ligament

  2. Thrombosite of Growth Factor - beta 1 [ Time Frame: 6 weeks ]
    measurement value of Thrombosite Growth Factor - beta 1

  3. basic fibroblast of growth factor [ Time Frame: 6 weeks ]
    measurement value of basic fibroblast of growth factor



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   2 Months to 12 Months   (Child)
Sexes Eligible for Study:   Male
Gender Based Eligibility:   Yes
Gender Eligibility Description:   white male rabbit
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • have no disease

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04889963


Contacts
Layout table for location contacts
Contact: sholahuddin rhatomy, MD +62 274 588688 ext 17225 rhatomy.s@gmail.com

Locations
Layout table for location information
Indonesia
Sholahuddin Rhatomy Recruiting
Sleman, Yogyakarta, Indonesia, 55571
Contact: sholahuddin rhatomy, MD    +62 274 588688 ext 17225    rhatomy.s@gmail.com   
Sponsors and Collaborators
Gadjah Mada University
Layout table for additonal information
Responsible Party: Sholahuddin Rhatomy, Director, Head of Orthopaedic Department,faculty of medicine,public health and nursing,universitas gadjah mada, Sholahuddin Rhatomy,MD, Gadjah Mada University
ClinicalTrials.gov Identifier: NCT04889963    
Other Study ID Numbers: STEMCELL-LIGAMENTREGENERATION
First Posted: May 17, 2021    Key Record Dates
Last Update Posted: May 17, 2021
Last Verified: May 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Sholahuddin Rhatomy, Gadjah Mada University:
adypose mesenchimal stem cell hypoxic culture conditioned
Ligament Rupture
ligament derived conditined medium
Additional relevant MeSH terms:
Layout table for MeSH terms
Rupture
Wounds and Injuries