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

University of Indonesia (UI)

Status and phase: Unknown; Phase 1

Conditions: Healing of Fracture

Treatments: Drug: stem cells + hydroxy apatite; Other: autograft taken from iliac crest

Study type: Interventional

Funder types: Other

Identifiers

NCT01626625

NONUNISTEM1

Details and patient eligibility

About

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.

Enrollment: 10 estimated patients

Sex: All

Ages: 18 to 55 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• athropic nonunion fracture of the long bone

Exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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10 participants in 2 patient groups

stem cells

Experimental group

Description:

stem cells + hydroxy apatite

Treatment:

Drug: stem cells + hydroxy apatite

autograft

Active Comparator group

Treatment:

Other: autograft taken from iliac crest