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

June 22, 2012 updated by: Ismail Hadisoebroto Dilogo, Indonesia University
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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

10

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 55 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • athropic nonunion fracture of the long bone

Exclusion Criteria:

  • immunocompromise,
  • active infection,
  • pathological fracture,
  • ongoing hormonal therapy

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: stem cells
stem cells + hydroxy apatite
Drug: stem cells + hydroxy apatite
patient will be transplanted with stem cells and hydroxyapatite
Active Comparator: autograft
Other: autograft taken from iliac crest
patient will be transplanted with autograft

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
healing of fracture
Time Frame: 1 year
radiological union
1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
VAS
Time Frame: 1 year
visual analogue scale
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Indonesia University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2010

Primary Completion (Anticipated)

April 1, 2015

Study Completion (Anticipated)

January 1, 2016

Study Registration Dates

First Submitted

June 12, 2012

First Submitted That Met QC Criteria

June 22, 2012

First Posted (Estimate)

June 25, 2012

Study Record Updates

Last Update Posted (Estimate)

June 25, 2012

Last Update Submitted That Met QC Criteria

June 22, 2012

Last Verified

June 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NONUNISTEM1

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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