MedTrace Logo

Mesenchymal Stem Cells in Osteonecrosis of the Femoral Head

NCT01605383 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 23

Last updated 2020-01-21

No results posted yet for this study

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.

Conditions

  • Avascular Necrosis of Femur Head

Interventions

BIOLOGICAL

XCEL-MT-OSTEO-ALPHA

Core decompression plus XCEL-MT-OSTEO-ALPHA

PROCEDURE

Standard treatment

Isolated core decompression

Sponsors & Collaborators

  • Ministerio de Sanidad, Servicios Sociales e Igualdad

    collaborator OTHER_GOV

  • Ministerio de Ciencia e Innovación, Spain

    collaborator OTHER_GOV

  • European Regional Development Fund

    collaborator OTHER

  • Banc de Sang i Teixits

    lead OTHER

Principal Investigators

  • Màrius Aguirre, MD, PhD · Hospital Vall d'Hebron

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-05-05
Primary Completion
2018-04-11
Completion
2019-06-27

Countries

  • Spain

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01605383 on ClinicalTrials.gov