Back to resultsRegeneration of Posterior Cruciate Ligament Injury Using Hypoxic Conditioned Allogenic Adipose Mesenchymal Stem Cell and Condition Medium
Primary Purpose
Adypose Mesenchimal Stem Cell, Ligament Rupture, Ligament Derived Conditined Medium
Status
Unknown status
Phase
Early Phase 1
Locations
Indonesia
Study Type
Interventional
Intervention
adypose mesenchymal conditioned medium and ligament derived conditioned medium
Sponsored by
About this trial
This is an interventional basic science trial for Adypose Mesenchimal Stem Cell focused on measuring adypose mesenchimal stem cell hypoxic culture conditioned, Ligament Rupture, ligament derived conditined medium
Eligibility Criteria
Inclusion Criteria:
- white male new zealand rabbit
- weight 2500 - 3000 gram
Exclusion Criteria:
- have no disease
Sites / Locations
- Sholahuddin RhatomyRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Placebo Comparator
Active Comparator
Active Comparator
Experimental
Arm Label
control group
conditioned medium group
stem cells group
composite group
Arm Description
rabbit with posterior cruciate ligament rupture and treated with fibrin glue (sacffold)
rabbit with posterior cruciate ligament rupture and treated with fibrin glue mix with ligament derived conditioned medium
rabbit with posterior cruciate ligament rupture and treated with fibrin glue mix with adypose mesenchymal stem cells in hypoxic culture condition
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
Outcomes
Primary Outcome Measures
tensile strength of posterior cruciate ligament
measurement of tensile strength of posterior cruciate ligament
Thrombosite of Growth Factor - beta 1
measurement value of Thrombosite Growth Factor - beta 1
basic fibroblast of growth factor
measurement value of basic fibroblast of growth factor
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04889963
Brief Title
Regeneration of Posterior Cruciate Ligament Injury Using Hypoxic Conditioned Allogenic Adipose Mesenchymal Stem Cell and Condition Medium
Official Title
Regeneration of Posterior Cruciate Ligament Injury Using Hypoxia Conditioned Allogenic Adipose Mesenchymal Stem Cell (AdMSC) and Ligament Derived Condition Medium (Secretome)
Study Type
Interventional
2. Study Status
Record Verification Date
May 2021
Overall Recruitment Status
Unknown status
Study Start Date
January 1, 2021 (Actual)
Primary Completion Date
June 30, 2021 (Anticipated)
Study Completion Date
June 30, 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Gadjah Mada University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Adypose Mesenchimal Stem Cell, Ligament Rupture, Ligament Derived Conditined Medium
Keywords
adypose mesenchimal stem cell hypoxic culture conditioned, Ligament Rupture, ligament derived conditined medium
7. Study Design
Primary Purpose
Basic Science
Study Phase
Early Phase 1
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
16 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
control group
Arm Type
Placebo Comparator
Arm Description
rabbit with posterior cruciate ligament rupture and treated with fibrin glue (sacffold)
Arm Title
conditioned medium group
Arm Type
Active Comparator
Arm Description
rabbit with posterior cruciate ligament rupture and treated with fibrin glue mix with ligament derived conditioned medium
Arm Title
stem cells group
Arm Type
Active Comparator
Arm Description
rabbit with posterior cruciate ligament rupture and treated with fibrin glue mix with adypose mesenchymal stem cells in hypoxic culture condition
Arm Title
composite group
Arm Type
Experimental
Arm Description
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
Intervention Type
Biological
Intervention Name(s)
adypose mesenchymal conditioned medium and ligament derived conditioned medium
Intervention Description
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 Measure Information:
Title
tensile strength of posterior cruciate ligament
Description
measurement of tensile strength of posterior cruciate ligament
Time Frame
6 weeks
Title
Thrombosite of Growth Factor - beta 1
Description
measurement value of Thrombosite Growth Factor - beta 1
Time Frame
6 weeks
Title
basic fibroblast of growth factor
Description
measurement value of basic fibroblast of growth factor
Time Frame
6 weeks
10. Eligibility
Sex
Male
Gender Based
Yes
Gender Eligibility Description
white male rabbit
Minimum Age & Unit of Time
2 Months
Maximum Age & Unit of Time
12 Months
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
white male new zealand rabbit
weight 2500 - 3000 gram
Exclusion Criteria:
have no disease
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
sholahuddin rhatomy, MD
Phone
+62 274 588688
Ext
17225
Email
rhatomy.s@gmail.com
Facility Information:
Facility Name
Sholahuddin Rhatomy
City
Sleman
State/Province
Yogyakarta
ZIP/Postal Code
55571
Country
Indonesia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
sholahuddin rhatomy, MD
Phone
+62 274 588688
Ext
17225
Email
rhatomy.s@gmail.com
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Regeneration of Posterior Cruciate Ligament Injury Using Hypoxic Conditioned Allogenic Adipose Mesenchymal Stem Cell and Condition Medium
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