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

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01700920

Acronym

CSM/ON/2011

Enrollment

Registered

2012-10-04

Start date

2012-07-31

Completion date

2015-12-31

Last updated

2017-03-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Osteonecrosis of the Femoral Head

Keywords

Osteonecrosis of the femoral head, Stem Cell, Mesenchymal Stem Cells, Femoral Head

Brief summary

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.

Interventions

PROCEDUREbone marrow aspirate

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 70 Years

Healthy volunteers

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.

Countries

Spain

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026