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

Study Overview
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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.

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.

Official Title
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Treatment of Long Bone Nonunion With Autologous Bone Marrow Stem Cells. Phase I/II Study

Conditions
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Long Bone Nonunion

Intervention / Treatment
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* Procedure: Osteosynthesis


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Bone marrow stem cells<br>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. | Procedure: Osteosynthesis<br>* To mix the cell suspension with osteogenic matrix and to use sheet and nails in order to consolidate the fracture<br>* Other names: fracture;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Absence of adverse effects during timeframe as infections or complications related with the intervention | 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. | Six months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Improvement and union of the bone | The improvement of the bone nonunion will be assessed by X-ray and NMR | One year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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bone nonunion, bone marrow, mononuclear, fracture