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

Phase 1

• Conditions: Healing of Fracture
• Interventions: Drug: stem cells + hydroxy apatite; Other: autograft taken from iliac crest

• Registration Number: NCT01626625
• Lead Sponsor: Indonesia University

Brief Summary

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

Not available

Study Timeline

• Study Start: 2010-04
• Status Verified: 2012-06
• Study First Submitted: 2012-06-12
• Study First Submitted QC: 2012-06-22
• Last Update Submitted: 2012-06-22
• Study First Posted: 2012-06-25
• Last Update Posted: 2012-06-25
• Primary Completion: 2015-04
• Study Completion: 2016-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 10

Inclusion Criteria

• athropic nonunion fracture of the long bone

Exclusion Criteria

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
stem cells	stem cells + hydroxy apatite	stem cells + hydroxy apatite
autograft	autograft taken from iliac crest	-

Primary Outcome Measures

Name	Time	Method
healing of fracture	1 year	radiological union

Secondary Outcome Measures

Name	Time	Method
VAS	1 year	visual analogue scale

Trial Locations

Locations (1)

RSCM; 🇮🇩 Jakarta, Indonesia