Completed
CSM/ON/2011PHASE II CLINICAL TRIAL Prospective, Open, Nonrandomized Treatment of Osteonecrosis of the Femoral Head by the Administration of Autologous Mesenchymal Stem Cells
What is being tested
bone marrow aspirate
Procedure
Who is being recruted
Bone Diseases+2
+ Femur Head Necrosis
+ Musculoskeletal Diseases
From 18 to 70 Years
+12 Eligibility Criteria
How is the trial designed
Treatment Study
Phase 2
Interventional
Study Start: July 2012
Summary
Principal SponsorRed de Terapia Celular
Last updated: March 30, 2017
Sourced from a government-validated database.Claim as a partner
Study start date: July 1, 2012
Actual date on which the first participant was enrolled.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.
Principal SponsorRed de Terapia Celular
Last updated: March 30, 2017
Sourced from a government-validated database.Claim as a partner
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.Design Details
3 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Conditions
Criteria
Any sex
Biological sex of participants that are eligible to enroll.From 18 to 70 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Bone DiseasesFemur Head NecrosisMusculoskeletal DiseasesOsteonecrosisLegg-Calve-Perthes Disease
Criteria
3 inclusion criteria required to participate
Age between 18 and 70 years
Clinical diagnosis and imaging (Rx and NMR) of idiopathic osteonecrosis of the femoral head
Stadiums < IIIC ARCO ranking
9 exclusion criteria prevent from participating
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
Acute infection (in the previous 15 days) or chronic (other than HIV)
Clinical criteria and anesthetics that contraindicate surgery (eg ASA IV-V)
Lack of informed consent or revocation thereof
Show More Criteria
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.Treatment Groups
One single intervention group is designated in this study
This study does not include a placebo group
Treatment Groups
Group I
ExperimentalCell 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.
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 1 location
University Hospital of Salamanca
Salamanca, SpainOpen University Hospital of Salamanca in Google MapsCompletedOne Study Center