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

Pseudoarthrosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01813188
• Other study ID #: TCBO-PS
• Status: Completed
• Phase: Phase 2
• First received: June 22, 2011
• Last updated: March 29, 2017
• Start date: April 2011
• Est. completion date: June 2014

Study information

• Verified date: March 2014
• Source: Fundacion para la Formacion e Investigacion Sanitarias de la Region de Murcia
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 5
• Est. completion date: June 2014
• Est. primary completion date: December 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Pseudarthrosis
• Pseudoarthrosis

Intervention

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)
• autologous bone graft
autologous bone graft

Locations

Country	Name	City	State
Spain	Hospital UniversitarioVirgen de la Arrixaca	El Palmar	Murcia

Sponsors (3)

Lead Sponsor	Collaborator
Fundacion para la Formacion e Investigacion Sanitarias de la Region de Murcia	Carlos III Health Institute, Hospital Universitario Virgen de la Arrixaca

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time needed to repair the focus of necrosis measured by pain radiography		Baseline and every 14 days up to 180 days
Secondary	Pain scale		Baseline and every 14 days up to 180 days
Secondary	Technical success	Understood as having been able to perform the implant of calcium phosphate matrix loaded with more than 100 million mononuclear cells	6 months
Secondary	Morbidity	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
Secondary	Absence of adverse events		6 months
Secondary	physical exploratory		Baseline and every 14 days up to 180 days
Secondary	Analgesia Scale		Baseline and every 14 days up to 180 days