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

August 24, 2015 updated by: Hospital Universitario Central de Asturias

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

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.

Study Overview

Status

Completed

Conditions

Intervention / 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 Type

Interventional

Enrollment (Actual)

7

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
    • Asturias
      • Oviedo, Asturias, Spain, 33006
        • Hospital Universitario Central de Asturias

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
Procedure: Osteosynthesis
To mix the cell suspension with osteogenic matrix and to use sheet and nails in order to consolidate the fracture
Other Names:
  • bone nonunion
  • bone marrow
  • mononuclear
  • fracture

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospital Universitario Central de Asturias

Investigators

  • Principal Investigator: Jesus Otero, MD, Unidad de Coordinación de Trasplantes, Terapia Celular y Medicina Regenerativa

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2011

Primary Completion (Actual)

September 1, 2012

Study Completion (Actual)

January 1, 2013

Study Registration Dates

First Submitted

April 9, 2012

First Submitted That Met QC Criteria

April 19, 2012

First Posted (Estimate)

April 20, 2012

Study Record Updates

Last Update Posted (Estimate)

August 25, 2015

Last Update Submitted That Met QC Criteria

August 24, 2015

Last Verified

August 1, 2015

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • HUCA

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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