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OpenTrials
Completed

NCT Number: NCT01700920

PHASE II CLINICAL TRIAL Prospective, Open, Nonrandomized Treatment of Osteonecrosis of the Femoral Head by the Administration of Autologous Mesenchymal Stem Cells

The purpose of this study is to analyze the safety and feasibility of direct administration intrafemoral mesenchymal stem cells (MSCs) in vitro expanded autologous treatment of patients with femoral osteonecrosis.

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Key information

Conditions

Osteonecrosis of the Femoral Head Bone Diseases Femur Head Necrosis Legg-Calve-Perthes Disease Musculoskeletal Diseases Osteonecrosis

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

University Hospital of Salamanca

Salamanca, Castille and León, 37007, Spain

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Age between 18 and 70 years
  • Clinical diagnosis and imaging (Rx and NMR) of idiopathic osteonecrosis of the femoral head
  • Stadiums <IIIC ARCO ranking

Exclusion criteria

  • Those on investigator judgment not in a good position to tolerate the procedure.
  • Clinical criteria and anesthetics that contraindicate surgery (eg ASA IV-V)
  • Serious illness uncontrolled
  • Pregnant women
  • Patients with HIV infection +
  • Acute infection (in the previous 15 days) or chronic (other than HIV)
  • Previous treatments of osteonecrosis
  • Active or previous neoplastic disease (last 5 years) except for patients undergoing allogeneic haematopoietic progenitors who are in complete remission after 2 years after transplantation.
  • Lack of informed consent or revocation thereof.

Treatment and study plan

Bone Marrow Aspirate

Procedure

Sponsors and collaborators

Lead sponsor

Red de Terapia Celular

Industry

Collaborators

  • Haematology Service,University Hospital of Salamanca, MªConsuelo del Cañizo Fernández-Roldán
  • Spanish National Health System

Registry information

Acronym: CSM/ON/2011

Important dates

Study start
2012
Primary completion
2015
Study completion
2015
First posted
Oct 4, 2012
Registry last updated
Mar 30, 2017

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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