Mesenchymal Stem Cells in Osteonecrosis of the Femoral Head

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2014 by Banc de Sang i Teixits
Sponsor:
Collaborators:
Ministerio de Sanidad, Servicios Sociales e Igualdad
Ministerio de Ciencia e Innovación, Spain
Cofunded by the European Union (European Regional development Fund (ERDF)
Information provided by (Responsible Party):
Banc de Sang i Teixits
ClinicalTrials.gov Identifier:
NCT01605383
First received: May 22, 2012
Last updated: July 16, 2014
Last verified: July 2014
  Purpose

The present study evaluates the effect of XCEL-MT-OSTEO-ALPHA in osteonecrosis of the femoral head in comparison to the standard treatment of isolated core decompression.

XCEL-MT-OSTEO-ALPHA is a tissue engineering product composed by "ex-vivo" expanded autologous mesenchymal stem cells fixed in allogenic bone tissue.

The working hypothesis proposes that the tissue engineering is a valid and useful technique to achieve bone regeneration, avoiding the progression to collapse of the femoral head.


Condition Intervention Phase
Avascular Necrosis of Femur Head
Biological: XCEL-MT-OSTEO-ALPHA
Procedure: Standard treatment
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Pilot Clinical Trial of "ex Vivo" Expanded Autologous Bone Marrow Mesenchymal Stem Cells Fixed in Allogenic Human Bone Tissue (XCEL-MT-OSTEO- ALPHA) in Osteonecrosis of the Femoral Head

Resource links provided by NLM:


Further study details as provided by Banc de Sang i Teixits:

Primary Outcome Measures:
  • Safety of XCEL-MT-OSTEO-ALPHA in osteonecrosis of the femoral head [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
    Safety will be assessed by collecting adverse events throughout the experimental phase, which includes a follow-up of 12 months

  • Feasibility of XCEL-MT-OSTEO-ALPHA in osteonecrosis of the femoral head [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
    Feasibility will be measured by assessing the percentage of patients to which bone marrow puncture is made are thereafter treated and by checking the cascade of procedures to confirm the global process is viable.


Secondary Outcome Measures:
  • Bone regeneration by measuring the necrotic angle using the modified Kerboul method [ Time Frame: 6 and 12 months ] [ Designated as safety issue: No ]
    The necrotic angle will be measured using imaging procedures (magnetic resonance imaging MRI).

  • Dynamic changes of signal intensity [ Time Frame: 6 and 12 months ] [ Designated as safety issue: No ]
    Dynamic changes of signal intensity after Gd enhancement in the necrotic areas of the femoral head

  • Clinical outcomes (pain) by Visual Analogue Scale (VAS) [ Time Frame: 7 days and at 3, 6 and 12 months ] [ Designated as safety issue: Yes ]
    Pain measurement by VAS

  • Clinical outcomes (SF-36) [ Time Frame: 3, 6 and 12 months ] [ Designated as safety issue: Yes ]
    This clinical outcome will measure the quality of life by the self-reported quality of life questionnaire SF-36

  • Clinical outcome (WOMAC) [ Time Frame: 3, 6 and 12 months ] [ Designated as safety issue: Yes ]
    To assess the extent by which a person's functional level is restricted by the WOMAC index


Estimated Enrollment: 24
Study Start Date: July 2012
Estimated Study Completion Date: June 2016
Estimated Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: XCEL-MT-OSTEO-ALPHA
"ex-vivo" expanded autologous mesenchymal stem cells fixed in allogenic bone tissue (under Xcelia-GMP conditions)for osteonecrosis of the femoral head
Biological: XCEL-MT-OSTEO-ALPHA
Core decompression plus XCEL-MT-OSTEO-ALPHA
Sham Comparator: Standard Treatment
Isolated core decompression
Procedure: Standard treatment
Isolated core decompression

Detailed Description:

Prospective, open-label with blinded assessor, randomized, parallel, single-dose phase I-II clinical trial in which 24 patients affected with osteonecrosis of the femoral head ARCO grade I or II will enter the trial with the primary objective of assessing the feasibility and safety of "ex-vivo" expanded autologous mesenchymal stem cells fixed in allogenic bone tissue in osteonecrosis of the femoral head. Secondary objectives are to assess the efficacy of the implantation by imaging (magnetic resonance imaging) and clinical questionnaires (pain by visual analogue scale, quality of life by SF-36 and WOMAC Index).

Patients will be randomized to one of the two treatment arms (core decompression and the tissue engineering product composed by "ex-vivo" expanded autologous mesenchymal stem cells fixed in allogenic bone tissue or the standard treatment of isolated core decompression). Thereafter, patients will be followed for 12 months.

  Eligibility

Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 18 to 50 years of age (male and female)
  • Osteonecrosis of the hip ARCO grade I or II
  • Abscence of systemic or local infection
  • Laboratory tests with no relevant abnormal findings that contraindicate the surgery.
  • Informed Consent Form signed
  • The patient is able to understand the nature of the study

Exclusion Criteria:

  • Osteonecrosis of the hip secondary to femoral neck fracture
  • Patients with no closed cartilage
  • Surgical implants in the femoral head
  • Septic arthritis
  • Patients with severe renal insufficiency
  • Patients expecting or with liver transplantation
  • Positive serology for HIV-1 or HIV-2, Hepatitis B (HBsAg), Hepatitis C (Anti-HCV-Ab) or Syphilis.
  • Pregnant woman or intended to become pregnant, or breath feeding
  • Neoplasia within the previous 5 years, or without remission
  • Immunosuppressive states
  • The patient is legally dependent
  • Participation in another clinical trial or treated with an investigational medicinal product the previous 30 days
  • Cardiac pacemaker, allergy to contrast or any other condition that contraindicates the MRI with contrast agents
  • Other pathologic conditions or circumstances that difficult participation in the study according to medical criteria
  • The patient does not accept to be followed-up for a period thar could exceed the clinical trial length
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01605383

Contacts
Contact: Ruth Coll, MD +34 93 557 3500 ext 6707 rucoll@bst.cat
Contact: Joan Garcia, MD, PhD +34 93 557 3500 joangarcia@bst.cat

Locations
Spain
Hospital Universitari Vall d'Hebron Recruiting
Barcelona, Spain, 08035
Contact: Màrius Aguirre, MD, PhD    +34 93 489 4000    maguirre@vhebron.net   
Principal Investigator: Màrius Aguirre, MD, PhD         
Sub-Investigator: Roberto Velez, MD, PhD         
Sub-Investigator: Alejandro Hernández, MD         
Sub-Investigator: Daniel Pacha, MD         
Sub-Investigator: Diego Collado, MD         
Sponsors and Collaborators
Banc de Sang i Teixits
Ministerio de Sanidad, Servicios Sociales e Igualdad
Ministerio de Ciencia e Innovación, Spain
Cofunded by the European Union (European Regional development Fund (ERDF)
Investigators
Principal Investigator: Màrius Aguirre, MD, PhD Hospital Universitari Vall d'Hebron
  More Information

Additional Information:
No publications provided

Responsible Party: Banc de Sang i Teixits
ClinicalTrials.gov Identifier: NCT01605383     History of Changes
Other Study ID Numbers: XCEL-MT-10-01, 2010-023998-18
Study First Received: May 22, 2012
Last Updated: July 16, 2014
Health Authority: Spain: Agencia Española de Medicamentos y Productos Sanitarios

Keywords provided by Banc de Sang i Teixits:
Avascular Necrosis of Femur Head
Osteonecrosis of the hip
Osteonecrosis of the femoral head
Mesenchymal Stem Cells
Bone marrow
Tissue engineering
Bone Diseases
Musculoskeletal Diseases

Additional relevant MeSH terms:
Necrosis
Osteonecrosis
Femur Head Necrosis
Pathologic Processes
Bone Diseases
Musculoskeletal Diseases

ClinicalTrials.gov processed this record on July 20, 2014