Clinical Trial Based on the Use of Mononuclear Cells From Autologous Bone Marrow in Patients With Pseudoarthrosis

NCT01813188 | Completed Phase 2 DMC

• 1 other identifier: TCBO-PS
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this clinical trial is to check the non-inferiority and lower morbidity of the use of bone marrow mononuclear cells seeded onto a porous matrix of calcium phosphate, for the consolidation of tibial bone defects (pseudoarthrosis), compared with autologous bone graft.

Conditions

Pseudoarthrosis

Keywords

Fractures; Bone; Stem Cells

Outcome Measures

Primary Outcomes (1)

• Time needed to repair the focus of necrosis measured by pain radiography

  Baseline and every 14 days up to 180 days

Secondary Outcomes (6)

• Pain scale

  Baseline and every 14 days up to 180 days

• Technical success

  6 months

• Morbidity

  6 months

• Absence of adverse events

  6 months

• physical exploratory

  Baseline and every 14 days up to 180 days

Study Arms (2)

ABM seeded onto a porous TCP and DBM

EXPERIMENTAL

ABM seeded onto a porous TCP and DBM

Procedure: ABM seeded onto a porous TCP and DBM

autologous bone graft

ACTIVE COMPARATOR

autologous bone graft

Procedure: autologous bone graft

Interventions

ABM seeded onto a porous TCP and DBM PROCEDURE

cells collection under sedation . 114 mL are obtained and processed through a ficoll gradient. Autologous bone marrow (ABM) cells seeded onto a porous tricalcium phosphate ceramic (TCP) and demineralized bone matrix (DBM)

ABM seeded onto a porous TCP and DBM

autologous bone graft PROCEDURE

autologous bone graft

autologous bone graft

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Pseudarthrosis of tibia established any cause with at least 9 months.
• The pseudarthrosis is not to show signs of healing in the last 3 months.
• The pseudarthrosis subsidiary should not be solely osteosynthesis treatment.
• Age between 18 and 75 years.
• Serology Human Immunodeficiency virus (HIV), hepatitis B virus (HBV) and hepatitis C virus (HCV) negative.
• Negative pregnancy test in women of childbearing age.
• Patient sufficient guarantees of adherence to protocol.
• Signature written informed consent before a witness

You may not qualify if:

• Systemic infection.
• Septic pseudoarthrosis.
• Insufficient skin coverage at the site of nonunion.
• Vascular insufficiency in the affected limb.
• Pathological fracture.
• Concomitant psychiatric or neurological disease.
• Concurrent or prior malignancy treated with chemotherapy over a period of less than 1 year.
• Concomitant severe disease not well controlled.
• Inability to understand the informed consent

Sponsors & Collaborators

• Fundacion para la Formacion e Investigacion Sanitarias de la Region de Murcia: lead
• Carlos III Health Institute: collaborator
• Hospital Universitario Virgen de la Arrixaca: collaborator

Study Sites (1)

Hospital UniversitarioVirgen de la Arrixaca

El Palmar, Murcia, 30120, Spain

Location

MeSH Terms

Conditions

Pseudarthrosis; Fractures, Bone

Interventions

Dopamine beta-Hydroxylase

Condition Hierarchy (Ancestors)

Fractures, Ununited; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Mixed Function Oxygenases; Oxygenases; Oxidoreductases; Enzymes; Enzymes and Coenzymes

Study Officials

• Luis Meseguer Olmo, MD,PhD

  Hospital Universitario Virgen de la Arrixaca

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 22, 2011
• First Posted: March 18, 2013
• Study Start: April 1, 2011
• Primary Completion: December 1, 2013
• Study Completion: June 1, 2014
• Last Updated: March 30, 2017

Record last verified: 2014-03

Locations

ES (1)