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

Hospital Universitario Central de Asturias

Status and phase: Completed; Phase 2; Phase 1

Conditions: Long Bone Nonunion

Treatments: Procedure: Osteosynthesis

Study type: Interventional

Funder types: Other

Identifiers

NCT01581892

HUCA

Details and patient eligibility

About

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.

Full 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.

Enrollment: 7 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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7 participants in 1 patient group

Bone marrow stem cells

Experimental group

Description:

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.

Treatment:

Procedure: Osteosynthesis