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

Healing of Fracture Clinical Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01626625
• Other study ID #: NONUNISTEM1
• Status: Recruiting
• Phase: Phase 1
• First received: June 12, 2012
• Last updated: June 22, 2012
• Start date: April 2010
• Est. completion date: January 2016

Study information

• Verified date: June 2012
• Source: Indonesia University
• Contact: Phedy Phe, MD
• Email: phedy[@]yahoo.com
• Is FDA regulated: No
• Health authority: Indonesia: Cipto Mangunkusumo Hospital
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 10
• Est. completion date: January 2016
• Est. primary completion date: April 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 55 Years

Eligibility

Inclusion Criteria:

• athropic nonunion fracture of the long bone

Exclusion Criteria:

• immunocompromise,

• active infection,

• pathological fracture,

• ongoing hormonal therapy

Study Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Healing of Fracture

Intervention

Drug:
• stem cells + hydroxy apatite
patient will be transplanted with stem cells and hydroxyapatite

Other:
• autograft taken from iliac crest
patient will be transplanted with autograft

Locations

Country	Name	City	State
Indonesia	RSCM	Jakarta

Sponsors (1)

Lead Sponsor	Collaborator
Indonesia University

Country where clinical trial is conducted

Indonesia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	healing of fracture	radiological union	1 year	No
Secondary	VAS	visual analogue scale	1 year	No