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

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ClinicalTrials.gov Identifier: NCT01626625
Recruitment Status : Unknown
Verified June 2012 by Ismail Hadisoebroto Dilogo, Indonesia University.
Recruitment status was:  Recruiting
First Posted : June 25, 2012
Last Update Posted : June 25, 2012
Sponsor:
Information provided by (Responsible Party):
Ismail Hadisoebroto Dilogo, 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.

Condition or disease Intervention/treatment Phase
Healing of Fracture Drug: stem cells + hydroxy apatite Other: autograft taken from iliac crest Phase 1

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 10 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Study Start Date : April 2010
Estimated Primary Completion Date : April 2015
Estimated Study Completion Date : January 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Fractures
Drug Information available for: Durapatite
U.S. FDA Resources

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



Primary Outcome Measures :
  1. healing of fracture [ Time Frame: 1 year ]
    radiological union


Secondary Outcome Measures :
  1. VAS [ Time Frame: 1 year ]
    visual analogue scale



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • athropic nonunion fracture of the long bone

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01626625


Contacts
Contact: Phedy Phe, MD phedy@yahoo.com
Contact: Ismail HD, PhD phedy2@yahoo.com

Locations
Indonesia
RSCM Recruiting
Jakarta, Indonesia
Contact: Phedy       phedy@yahoo.com   
Sponsors and Collaborators
Indonesia University

Responsible Party: Ismail Hadisoebroto Dilogo, PhD, Indonesia University
ClinicalTrials.gov Identifier: NCT01626625     History of Changes
Other Study ID Numbers: NONUNISTEM1
First Posted: June 25, 2012    Key Record Dates
Last Update Posted: June 25, 2012
Last Verified: June 2012

Keywords provided by Ismail Hadisoebroto Dilogo, Indonesia University:
nonunion
stem cells
autograft
hydroxyapatite

Additional relevant MeSH terms:
Fractures, Bone
Wounds and Injuries