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

Status

UNKNOWN

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01626625

Enrollment

Registered

2012-06-25

Start date

2010-04-30

Completion date

2016-01-31

Last updated

2012-06-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healing of Fracture

Keywords

nonunion, stem cells, autograft, hydroxyapatite

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.

Interventions

DRUGstem cells + hydroxy apatite

patient will be transplanted with stem cells and hydroxyapatite

OTHERautograft taken from iliac crest

patient will be transplanted with autograft

Study design

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 55 Years

Healthy volunteers

Inclusion criteria

* athropic nonunion fracture of the long bone

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame	Description
healing of fracture	1 year	radiological union

Secondary

Measure	Time frame	Description
VAS	1 year	visual analogue scale

Countries

Indonesia

Contacts

Primary ContactPhedy Phe, MD

phedy@yahoo.com

Backup ContactIsmail HD, PhD

phedy2@yahoo.com

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026