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Completed

NCT Number: NCT01605383

Mesenchymal Stem Cells in Osteonecrosis of the Femoral Head

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.

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Key information

Conditions

Avascular Necrosis of Femur Head Bone Diseases Femur Head Necrosis Legg-Calve-Perthes Disease Musculoskeletal Diseases Necrosis Osteonecrosis Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Hospital Universitari Vall d'Hebron

Barcelona, 08035, Spain

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

XCEL-MT-OSTEO-ALPHA

Biological

Core decompression plus XCEL-MT-OSTEO-ALPHA

Standard treatment

Procedure

Isolated core decompression

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Banc de Sang i Teixits

Other

Collaborators

  • European Regional Development Fund
  • Ministerio de Ciencia e Innovación, Spain
  • Ministerio de Sanidad, Servicios Sociales e Igualdad

Registry information

Official study 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

Important dates

Study start
2015
Primary completion
2018
Study completion
2019
First posted
May 24, 2012
Registry last updated
Jan 21, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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