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Mesenchymal Stem Cells in Osteonecrosis of the Femoral Head

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ClinicalTrials.gov Identifier: NCT01605383
Recruitment Status : Completed
First Posted : May 24, 2012
Last Update Posted : January 21, 2020
Sponsor:
Collaborators:
Ministerio de Sanidad, Servicios Sociales e Igualdad
Ministerio de Ciencia e Innovación, Spain
European Regional Development Fund
Information provided by (Responsible Party):
Banc de Sang i Teixits

Study Description
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Brief Summary:

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

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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 23 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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
Actual Study Start Date : May 5, 2015
Actual Primary Completion Date : April 11, 2018
Actual Study Completion Date : June 27, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Osteonecrosis

Arms and Interventions
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Arm Intervention/treatment
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


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

  2. Feasibility of XCEL-MT-OSTEO-ALPHA in osteonecrosis of the femoral head [ Time Frame: 12 months ]
    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 :
  1. Bone regeneration by measuring the necrotic angle using the modified Kerboul method [ Time Frame: 6 and 12 months ]
    The necrotic angle will be measured using imaging procedures (magnetic resonance imaging MRI).

  2. Dynamic changes of signal intensity [ Time Frame: 6 and 12 months ]
    Dynamic changes of signal intensity after Gd enhancement in the necrotic areas of the femoral head

  3. Clinical outcomes (pain) by Visual Analogue Scale (VAS) [ Time Frame: 7 days and at 3, 6 and 12 months ]
    Pain measurement by VAS

  4. Clinical outcomes (SF-36) [ Time Frame: 3, 6 and 12 months ]
    This clinical outcome will measure the quality of life by the self-reported quality of life questionnaire SF-36

  5. Clinical outcome (WOMAC) [ Time Frame: 3, 6 and 12 months ]
    To assess the extent by which a person's functional level is restricted by the WOMAC index


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01605383


Locations
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Spain
Hospital Universitari Vall d'Hebron
Barcelona, Spain, 08035
Sponsors and Collaborators
Banc de Sang i Teixits
Ministerio de Sanidad, Servicios Sociales e Igualdad
Ministerio de Ciencia e Innovación, Spain
European Regional Development Fund
Investigators
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Principal Investigator: Màrius Aguirre, MD, PhD Hospital Vall d'Hebron
More Information
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Additional Information:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Banc de Sang i Teixits
ClinicalTrials.gov Identifier: NCT01605383    
Other Study ID Numbers: XCEL-MT-10-01
2010-023998-18 ( EudraCT Number )
First Posted: May 24, 2012    Key Record Dates
Last Update Posted: January 21, 2020
Last Verified: January 2020
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:
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Osteonecrosis
Legg-Calve-Perthes Disease
Femur Head Necrosis
Necrosis
 Pathologic Processes
Bone Diseases
Musculoskeletal Diseases