Use of Adult Bone Marrow Mononuclear Cells in Patients With Long Bone Nonunion

Phase 1

Completed

• Conditions: Long Bone Nonunion
• Interventions: Procedure: Osteosynthesis

• Registration Number: NCT01581892
• Lead Sponsor: Hospital Universitario Central de Asturias

Brief Summary

The aim of the study is to determine the safety and feasibility of autologous mononuclear stem cells in long bone nonunion; and moreover, to evaluate the efficacy of the treatment.

Detailed Description

In this study the investigators examine the improvement of conventional surgical treatment of long bone nonunion with the administration of bone marrow stem cells in order to achieve a higher percentage of healing and tissue reparation.

Study Timeline

• Study Start: 2011-12
• Study First Submitted: 2012-04-09
• Study First Submitted QC: 2012-04-19
• Study First Posted: 2012-04-20
• Primary Completion: 2012-09
• Study Completion: 2013-01
• Status Verified: 2015-08
• Last Update Submitted: 2015-08-24
• Last Update Posted: 2015-08-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 7

Inclusion Criteria

• diagnosed long bone nonunion
• age from 18 years old

Exclusion Criteria

• active infection
• cancer patients
• concomitant serious illness
• pregnant women
• evidences of mental illness
• previous alcohol or drug dependences
• previous malignant disease during last 5 years, except for basal carcinoma

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Bone marrow stem cells	Osteosynthesis	Bone marrow is obtained by posterosuperior iliac crest aspiration under topical anesthesia. Mononuclear cells were isolated by Ficoll density gradient and will be resuspended in heparinized isotonic saline for mixing with osteogenic matrix.

Primary Outcome Measures

Name	Time	Method
Absence of adverse effects during timeframe as infections or complications related with the intervention	Six months	The proposed trial will involve the recruitment of a total of 30 patients. The cells will be collected via bone marrow sampling. The aspirate will be centrifuged on a Ficoll density gradient to isolate mononuclear cells, wich will be resuspended in heparinized isotonic saline and used in order to infuse into the area surgically treated. The surgical intervention means the introduction of a sheet with nails according with the usually employed technique.

Secondary Outcome Measures

Name	Time	Method
Improvement and union of the bone	One year	The improvement of the bone nonunion will be assessed by X-ray and NMR

Trial Locations

Locations (1)

Hospital Universitario Central de Asturias; 🇪🇸 Oviedo, Asturias, Spain