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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2012 by Indonesia University.
Recruitment status was  Recruiting
Information provided by (Responsible Party):
Ismail Hadisoebroto Dilogo, Indonesia University Identifier:
First received: June 12, 2012
Last updated: June 22, 2012
Last verified: June 2012
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:

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


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

Inclusion Criteria:

  • athropic nonunion fracture of the long bone

Exclusion Criteria:

  • immunocompromise,
  • active infection,
  • pathological fracture,
  • ongoing hormonal therapy
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01626625

Contact: Phedy Phe, MD
Contact: Ismail HD, PhD

RSCM Recruiting
Jakarta, Indonesia
Contact: Phedy   
Sponsors and Collaborators
Indonesia University
  More Information

Responsible Party: Ismail Hadisoebroto Dilogo, PhD, Indonesia University 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:
stem cells
hydroxyapatite processed this record on April 27, 2016