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

March 29, 2017 updated by: Fundacion para la Formacion e Investigacion Sanitarias de la Region de Murcia

Phase II Clinical Trial of Tissue Engineering Based on the Use of Mononuclear Cells From Autologous Bone Marrow Seeded on Porous Tricalcium Phosphate Biomaterial in Patients With Pseudoarthrosis

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

An estimated 10% of closed fractures and between 35-45% in cases of open fractures, are at risk of developing a delay in the process of consolidation or a complete failure of it (pseudoarthrosis) depending on location , severity of trauma on bone, soft tissue and vascular structures Some of these cases are refractory to all treatment methods available today, requiring numerous interventions with the potential risk for recurrent infections that they carry. For this reason, its treatment remains a challenge for the orthopedic surgeon.

Recent advances in knowledge of cellular and molecular biology related to the mechanism of bone repair and biomaterials science have been joined in a new discipline called tissue engineering, its implementation in clinical practice is being done so progressive.

Cell therapy based on the use of adult stem cells (MSCs) derived from autologous bone marrow, introduces new applications for the repair of fractures including pseudoarthrosis and avascular bone necrosis.

Its mechanism of action does not focus only on their local action, but also in the release of signaling molecules with autocrine and paracrine action through recruitment and activation of endogenous MSCs to osteoblastic differentiation and bone tissue regeneration.

On the other hand, the seeding of MSCs on biomaterials (natural or synthetic) is more effective, to facilitate adherence, proliferation and extracellular matrix production in the area where implanted.

Today, the investigators can say that there are experimental and clinical evidence supporting the effectiveness of the method.

The investigators have designed a phase II clinical trial to check the feasibility of this approach.

Study Type

Interventional

Enrollment (Actual)

5

Phase

  • Phase 2

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
    • Murcia
      • El Palmar, Murcia, Spain, 30120
        • Hospital UniversitarioVirgen de la Arrixaca

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 to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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.
  • Inclusion in other clinical trials.
  • Inability to understand the informed consent

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: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: ABM seeded onto a porous TCP and DBM
Procedure: ABM seeded onto a porous TCP and DBM

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)
Active Comparator: autologous bone graft
Procedure: autologous bone graft
autologous bone graft

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Time needed to repair the focus of necrosis measured by pain radiography
Time Frame: Baseline and every 14 days up to 180 days
Baseline and every 14 days up to 180 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pain scale
Time Frame: Baseline and every 14 days up to 180 days
Baseline and every 14 days up to 180 days
Technical success
Time Frame: 6 months
Understood as having been able to perform the implant of calcium phosphate matrix loaded with more than 100 million mononuclear cells
6 months
Morbidity
Time Frame: 6 months
Infection of extraction points Pathological fracture of the extraction area Muscle hernia Stress fracture Infection of focus repaired Rupture of the focus fixture repaired Appearance of secondary malignancies
6 months
Absence of adverse events
Time Frame: 6 months
6 months
physical exploratory
Time Frame: Baseline and every 14 days up to 180 days
Baseline and every 14 days up to 180 days
Analgesia Scale
Time Frame: Baseline and every 14 days up to 180 days
Baseline and every 14 days up to 180 days

Collaborators and Investigators

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

Sponsor

Fundacion para la Formacion e Investigacion Sanitarias de la Region de Murcia

Collaborators

Carlos III Health Institute
Hospital Universitario Virgen de la Arrixaca

Investigators

  • Principal Investigator: Luis Meseguer Olmo, MD,PhD, Hospital Universitario Virgen de la Arrixaca

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

April 1, 2011

Primary Completion (Actual)

December 1, 2013

Study Completion (Actual)

June 1, 2014

Study Registration Dates

First Submitted

June 22, 2011

First Submitted That Met QC Criteria

March 13, 2013

First Posted (Estimate)

March 18, 2013

Study Record Updates

Last Update Posted (Actual)

March 30, 2017

Last Update Submitted That Met QC Criteria

March 29, 2017

Last Verified

March 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TCBO-PS

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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