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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

7 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-12-31

Study Completion Date

2013-01-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Long Bone Nonunion

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Bone marrow stem cells

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.

Group Type EXPERIMENTAL

Osteosynthesis

Intervention Type PROCEDURE

To mix the cell suspension with osteogenic matrix and to use sheet and nails in order to consolidate the fracture

Interventions

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Osteosynthesis

To mix the cell suspension with osteogenic matrix and to use sheet and nails in order to consolidate the fracture

Intervention Type PROCEDURE

Other Intervention Names

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bone nonunion bone marrow mononuclear fracture

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No