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PHASE II CLINICAL TRIAL Prospective, Open, Nonrandomized Treatment of Osteonecrosis of the Femoral Head by the Administration of Autologous Mesenchymal Stem Cells (CSM/ON/2011)

This study has been completed.
Sponsor:
Collaborators:
Haematology Service,University Hospital of Salamanca, MªConsuelo del Cañizo Fernández-Roldán
Spanish National Health System
Information provided by (Responsible Party):
Red de Terapia Celular
ClinicalTrials.gov Identifier:
NCT01700920
First received: October 2, 2012
Last updated: March 29, 2017
Last verified: March 2017
  Purpose
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.

Condition Intervention Phase
Osteonecrosis of the Femoral Head Procedure: bone marrow aspirate Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: PHASE II CLINICAL TRIAL Prospective, Open, Nonrandomized Treatment of Osteonecrosis of the Femoral Head by the Administration of Autologous Mesenchymal Stem Cells

Resource links provided by NLM:


Further study details as provided by Red de Terapia Celular:

Enrollment: 3
Study Start Date: July 2012
Study Completion Date: December 2015
Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Mesenchymal Stem Cell

Cell suspension mesenchymal stem cells (MSCs) obtained from bone marrow aspirate from the patient and expanded in vitro in a specific medium enriched with platelet lysate without addition of animal products.

They employ a minimum dose of 0.5 x 106 MSC / kg and a maximum of 1, 0x106 CSM / kg of patient weight.

Pharmaceutical form: Suspension cell Route of administration: local implant intraosseous injection with trocar in the femoral head.

Procedure: bone marrow aspirate

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01700920

Locations
Spain
University Hospital of Salamanca
Salamanca, Castilla y León, Spain, 37007
Sponsors and Collaborators
Red de Terapia Celular
Haematology Service,University Hospital of Salamanca, MªConsuelo del Cañizo Fernández-Roldán
Spanish National Health System
  More Information

Additional Information:
Responsible Party: Red de Terapia Celular
ClinicalTrials.gov Identifier: NCT01700920     History of Changes
Other Study ID Numbers: CSM/ON/2011
Study First Received: October 2, 2012
Last Updated: March 29, 2017

Keywords provided by Red de Terapia Celular:
Osteonecrosis of the femoral head
Stem Cell
Mesenchymal Stem Cells
Femoral Head

Additional relevant MeSH terms:
Osteonecrosis
Bone Diseases
Musculoskeletal Diseases
Necrosis
Pathologic Processes

ClinicalTrials.gov processed this record on August 21, 2017