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

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2012 by Indonesia University
Sponsor:
Information provided by (Responsible Party):
Ismail Hadisoebroto Dilogo, Indonesia University
ClinicalTrials.gov Identifier:
NCT01626625
First received: June 12, 2012
Last updated: June 22, 2012
Last verified: June 2012

June 12, 2012
June 22, 2012
April 2010
April 2015   (final data collection date for primary outcome measure)
healing of fracture [ Time Frame: 1 year ] [ Designated as safety issue: No ]
radiological union
Same as current
Complete list of historical versions of study NCT01626625 on ClinicalTrials.gov Archive Site
VAS [ Time Frame: 1 year ] [ Designated as safety issue: No ]
visual analogue scale
Same as current
Not Provided
Not Provided
 
Mesenchymal Stem Cells; Donor and Role in Management and Reconstruction of Nonunion Fracture
Not Provided

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.

Not Provided
Interventional
Phase 1
Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Treatment
Healing of Fracture
  • 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
  • Experimental: stem cells
    stem cells + hydroxy apatite
    Intervention: Drug: stem cells + hydroxy apatite
  • Active Comparator: autograft
    Intervention: Other: autograft taken from iliac crest
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
10
January 2016
April 2015   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • athropic nonunion fracture of the long bone

Exclusion Criteria:

  • immunocompromise,
  • active infection,
  • pathological fracture,
  • ongoing hormonal therapy
Both
18 Years to 55 Years
No
Contact: Phedy Phe, MD phedy@yahoo.com
Contact: Ismail HD, PhD phedy2@yahoo.com
Indonesia
 
NCT01626625
NONUNISTEM1
Yes
Ismail Hadisoebroto Dilogo, Indonesia University
Indonesia University
Not Provided
Not Provided
Indonesia University
June 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP