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

NCT ID: NCT04889963

Last Updated: 2021-05-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

EARLY_PHASE1

Total Enrollment

16 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-01-01

Study Completion Date

2021-06-30

Brief Summary

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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

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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

Conditions

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Adypose Mesenchimal Stem Cell Ligament Rupture Ligament Derived Conditined Medium

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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control group

rabbit with posterior cruciate ligament rupture and treated with fibrin glue (sacffold)

Group Type PLACEBO_COMPARATOR

adypose mesenchymal conditioned medium and ligament derived conditioned medium

Intervention Type BIOLOGICAL

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

conditioned medium group

rabbit with posterior cruciate ligament rupture and treated with fibrin glue mix with ligament derived conditioned medium

Group Type ACTIVE_COMPARATOR

adypose mesenchymal conditioned medium and ligament derived conditioned medium

Intervention Type BIOLOGICAL

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

stem cells group

rabbit with posterior cruciate ligament rupture and treated with fibrin glue mix with adypose mesenchymal stem cells in hypoxic culture condition

Group Type ACTIVE_COMPARATOR

adypose mesenchymal conditioned medium and ligament derived conditioned medium

Intervention Type BIOLOGICAL

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

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

Group Type EXPERIMENTAL

adypose mesenchymal conditioned medium and ligament derived conditioned medium

Intervention Type BIOLOGICAL

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

Interventions

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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

Intervention Type BIOLOGICAL

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* have no disease
Minimum Eligible Age

2 Months

Maximum Eligible Age

12 Months

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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Gadjah Mada University

OTHER

Sponsor Role lead

Responsible Party

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Sholahuddin Rhatomy

Director, Head of Orthopaedic Department,faculty of medicine,public health and nursing,universitas gadjah mada, Sholahuddin Rhatomy,MD

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Sholahuddin Rhatomy

Sleman, Special Region of Yogyakarta, Indonesia

Site Status RECRUITING

Countries

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Indonesia

Central Contacts

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sholahuddin rhatomy, MD

Role: CONTACT

+62 274 588688 ext. 17225

Facility Contacts

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sholahuddin rhatomy, MD

Role: primary

+62 274 588688 ext. 17225

Other Identifiers

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STEMCELL-LIGAMENTREGENERATION

Identifier Type: -

Identifier Source: org_study_id

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