Mesenchymal Stem Cells in Osteonecrosis of the Femoral Head

January 15, 2020 updated by: Banc de Sang i Teixits

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

23

Phase

  • Phase 2
  • Phase 1

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
      • Barcelona, Spain, 08035
        • Hospital Universitari Vall d'Hebron

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 50 years (ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

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
  • Masking: NONE

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
12 months
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.
12 months

Secondary Outcome Measures

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

Collaborators and Investigators

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

Sponsor

Banc de Sang i Teixits

Collaborators

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

Investigators

  • Principal Investigator: Màrius Aguirre, MD, PhD, Hospital Vall d'Hebron

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

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 (Actual)

May 5, 2015

Primary Completion (Actual)

April 11, 2018

Study Completion (Actual)

June 27, 2019

Study Registration Dates

First Submitted

May 22, 2012

First Submitted That Met QC Criteria

May 23, 2012

First Posted (Estimate)

May 24, 2012

Study Record Updates

Last Update Posted (Actual)

January 21, 2020

Last Update Submitted That Met QC Criteria

January 15, 2020

Last Verified

January 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • XCEL-MT-10-01
  • 2010-023998-18 (EudraCT Number)

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.

Clinical Trials on Avascular Necrosis of Femur Head

Clinical Trials on XCEL-MT-OSTEO-ALPHA

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Portugal

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe