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A Comparative Study of 2 Doses of BM Autologous H-MSC+Biomaterial vs Iliac Crest AutoGraft for Bone Healing in Non-Union

NCT03325504 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 46

Last updated 2024-12-04

No results posted yet for this study

Summary

ORTHOUNION is a multi-centre, open, comparative, randomized, clinical trial with three parallel arms that aims to compare the efficacy of three treatments to enhance bone healing in patients with long bone non-union.

Conditions

  • Non Union Fracture

Interventions

BIOLOGICAL

Cultured Mesenchymal Stem Cells

Cultured Mesenchymal Stem Cells obtained from expanded bone marrow

PROCEDURE

Autologous iliac crest graft

Autologous iliac crest grafting

Sponsors & Collaborators

  • Universidad Autonoma de Madrid

    lead OTHER

Principal Investigators

  • Enrique Gomez-Barrena, Prof · Universidad Autonoma de Madrid

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
99 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-09-05
Primary Completion
2022-10-17
Completion
2023-12-15

Countries

  • France
  • Germany
  • Italy
  • Spain

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03325504 on ClinicalTrials.gov