NCT04889963

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
16

participants targeted

Target at P25-P50 for early_phase_1

Timeline
Completed

Started Jan 2021

Shorter than P25 for early_phase_1

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2021

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

May 9, 2021

Completed
8 days until next milestone

First Posted

Study publicly available on registry

May 17, 2021

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2021

Completed
Last Updated

May 17, 2021

Status Verified

May 1, 2021

Enrollment Period

6 months

First QC Date

May 9, 2021

Last Update Submit

May 14, 2021

Conditions

Adypose Mesenchimal Stem CellLigament RuptureLigament Derived Conditined Medium

Keywords

adypose mesenchimal stem cell hypoxic culture conditionedLigament Ruptureligament derived conditined medium

Outcome Measures

Primary Outcomes (3)

  • tensile strength of posterior cruciate ligament

    measurement of tensile strength of posterior cruciate ligament

    6 weeks

  • Thrombosite of Growth Factor - beta 1

    measurement value of Thrombosite Growth Factor - beta 1

    6 weeks

  • basic fibroblast of growth factor

    measurement value of basic fibroblast of growth factor

    6 weeks

Study Arms (4)

control group

PLACEBO COMPARATOR

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

Biological: adypose mesenchymal conditioned medium and ligament derived conditioned medium

conditioned medium group

ACTIVE COMPARATOR

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

stem cells group

ACTIVE COMPARATOR

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

composite group

EXPERIMENTAL

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

Interventions

adypose mesenchymal conditioned medium and ligament derived conditioned mediumBIOLOGICAL

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 groupconditioned medium groupcontrol groupstem cells group

Eligibility Criteria

Age2 Months - 12 Months
Sexmale(Gender-based eligibility)
Gender Eligibility Detailswhite male rabbit
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

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

You may not qualify if:

  • have no disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sholahuddin Rhatomy

Sleman, Special Region of Yogyakarta, 55571, Indonesia

RECRUITING

Central Study Contacts

sholahuddin rhatomy, MD

CONTACT

+62 274 588688rhatomy.s@gmail.com

Study Design

Study Type
interventional
Phase
early phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director, Head of Orthopaedic Department,faculty of medicine,public health and nursing,universitas gadjah mada, Sholahuddin Rhatomy,MD

Study Record Dates

First Submitted

May 9, 2021

First Posted

May 17, 2021

Study Start

January 1, 2021

Primary Completion

June 30, 2021

Study Completion

June 30, 2021

Last Updated

May 17, 2021

Record last verified: 2021-05

Locations

ID(1)