Mesenchymal Stem Cells; Donor and Role in Management and Reconstruction of Nonunion Fracture

NCT ID: NCT01626625

Last Updated: 2012-06-25

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

PHASE1

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-04-30

Study Completion Date

2016-01-31

Brief Summary

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The investigators hypothesized that mesenchymal stem cells can be isolated from fracture site, iliac crest, and tibial crest, and can be expanded to be used in the management of nonunion fracture.

Detailed Description

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Conditions

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Healing of Fracture

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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stem cells

stem cells + hydroxy apatite

Group Type EXPERIMENTAL

stem cells + hydroxy apatite

Intervention Type DRUG

patient will be transplanted with stem cells and hydroxyapatite

autograft

Group Type ACTIVE_COMPARATOR

autograft taken from iliac crest

Intervention Type OTHER

patient will be transplanted with autograft

Interventions

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stem cells + hydroxy apatite

patient will be transplanted with stem cells and hydroxyapatite

Intervention Type DRUG

autograft taken from iliac crest

patient will be transplanted with autograft

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* athropic nonunion fracture of the long bone

Exclusion Criteria

* immunocompromise,
* active infection,
* pathological fracture,
* ongoing hormonal therapy
Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Indonesia University

OTHER

Sponsor Role lead

Responsible Party

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Ismail Hadisoebroto Dilogo

PhD

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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RSCM

Jakarta, , Indonesia

Site Status RECRUITING

Countries

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Indonesia

Central Contacts

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Phedy Phe, MD

Role: CONTACT

Ismail HD, PhD

Role: CONTACT

Facility Contacts

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Phedy

Role: primary

Other Identifiers

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NONUNISTEM1

Identifier Type: -

Identifier Source: org_study_id

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