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

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

Status

Completed

Phases

Phase 1Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01581892

Enrollment

Registered

2012-04-20

Start date

2011-12-31

Completion date

2013-01-31

Last updated

2015-08-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Long Bone Nonunion

Keywords

bone nonunion, bone marrow, mononuclear, fracture

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.

Interventions

PROCEDUREOsteosynthesis

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

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
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

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

Countries

Spain

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026