Osteonecrosis of the Femoral HeadPhase 2CSM/ON/2011NCT01700920

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

A Phase 2 study testing bone marrow aspirate in people with Osteonecrosis of the Femoral Head, run by Red de Terapia Celular at 1 site in Spain.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 18 to 70 years
Conditions the study is for: Osteonecrosis of the Femoral Head
What is being tested?: bone marrow aspirate
Type of treatment: Injection or infusion, Surgery or procedure
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 3 participants
Where: 1 siteSpain
Study dates: Jul 2012to Dec 2015
Phase: Phase 2

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 70 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

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)

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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.

Trial locations and contacts

1 site in 1 country.

Spain1 site

University Hospital of Salamanca
Salamanca, Castille and León, 37007

Other trials in Spain

About this study

Conditions: Osteonecrosis of the Femoral Head
Being tested: bone marrow aspirate
Keywords: Osteonecrosis of the femoral head, Stem Cell, Mesenchymal Stem Cells, Femoral Head
Medical subject headings: Legg-Calve-Perthes Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

bone marrow aspirateProcedure or surgery

Study groups in NCT01700920
Study group	Role	What they receive
Mesenchymal Stem Cell	Experimental	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. Receives: Procedure: bone marrow aspirate

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jul 2012Dec 2015

First posted4 Oct 2012 (estimated)
Study startJul 2012
Primary completionDec 2015
Study completionDec 2015

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Osteonecrosis of the Femoral HeadStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 3 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01700920
Sponsor's protocol ID: CSM/ON/2011
Acronym: CSM/ON/2011
Status last verified: Mar 2017
First submitted: 2 Oct 2012
Last updated: 30 Mar 2017
Results posted: No
Data monitoring committee: Yes

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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