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Completed

NCT Number: NCT01581892

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

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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Key information

Conditions

Long Bone Nonunion Fractures, Bone Wounds and Injuries

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Hospital Universitario Central de Asturias

Oviedo, Principality of Asturias, 33006, Spain

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Osteosynthesis

Procedure

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

Primary outcomes

  1. 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.

Secondary outcomes

  1. Improvement and union of the bone

    Time frame: One year

    The improvement of the bone nonunion will be assessed by X-ray and NMR

Sponsors and collaborators

Lead sponsor

Hospital Universitario Central de Asturias

Other

Registry information

Official study title

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

Important dates

Study start
2011
Primary completion
2012
Study completion
2013
First posted
Apr 20, 2012
Registry last updated
Aug 25, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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