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

This study is currently recruiting participants.
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
History of Changes
  Purpose

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 Intervention Phase
Healing of Fracture
 Drug: stem cells + hydroxy apatite
Other: autograft taken from iliac crest
 Phase 1

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

Resource links provided by NLM:

MedlinePlus related topics: Fractures
U.S. FDA Resources

Further study details as provided by Indonesia University:

Primary Outcome Measures:
  • healing of fracture [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    radiological union


Secondary Outcome Measures:
  • VAS [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    visual analogue scale


Estimated Enrollment: 10
Study Start Date: April 2010
Estimated Study Completion Date: January 2016
Estimated Primary Completion Date: April 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • athropic nonunion fracture of the long bone

Exclusion Criteria:

  • immunocompromise,
  • active infection,
  • pathological fracture,
  • ongoing hormonal therapy
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

No publications provided

Responsible Party: Ismail Hadisoebroto Dilogo, PhD, Indonesia University
ClinicalTrials.gov Identifier: NCT01626625     History of Changes
Other Study ID Numbers: NONUNISTEM1
Study First Received: June 12, 2012
Last Updated: June 22, 2012
Health Authority: Indonesia: Cipto Mangunkusumo Hospital

Keywords provided by Indonesia University:
nonunion
stem cells
autograft
hydroxyapatite

Additional relevant MeSH terms:
Fractures, Bone
Wounds and Injuries

ClinicalTrials.gov processed this record on June 17, 2013