Evaluation of Mesenchymal Stem Cells to Treat Avascular Necrosis of the Hip (ORTHO-2)

October 5, 2021 updated by: Prof Enrique Gomez-Barrena, Universidad Autonoma de Madrid

Evaluation of Safety and Feasibility of Bone Marrow Derived Autologous MSCs to Enhance Bone Healing in Patients With Avascular Necrosis of the Femoral Head

The purpose is to assess the safety and feasibility of cellular therapy derived from bone marrow, to help bone healing in patients with avascular necrosis of the hip.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

To assess the safety and feasibility of an in situ single injection of a high dose of autologous bone marrow-derived, in vitro expanded Mesenchymal stem cells, and its contribution to the resolution of the early stages of avascular osteonecrosis of the femoral head.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
26

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Créteil, France, 94000
        • Department of Orthopaedic Surgery, Hôpital Henri Mondor
      • Tours, France, 37044
        • Department of Orthopaedic Surgery, CHU Tours
  • Germany
      • Tübingen, Germany, 72076
        • University Children's Hospital
      • Ulm, Germany, 8907581
        • Department of Orthopaedic Trauma, University of Ulm
  • Italy
      • Bologna, Italy, 40136
        • Istituto Ortopedico Rizzoli
  • Spain
      • Madrid, Spain, 28046
        • Servicio de Cirugía Ortopédica y Traumatología "A", Hospital La Paz

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

14 years to 61 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

Age 18 to 65, both sexes

  • Early avascular necrosis of the fem oral head (MRI diagnosis): Ficat and Arlet 0, 1, or 2 (Steinberg stages 0, I, IIA, IIB, or IIC)
  • Sym ptom atic osteonecrosis with less than 6 months of evolution
  • Able to provide informed consent, and signed informed consent
  • Medical health care coverage

Exclusion Criteria:

  • Pregnancy, breast feeding women and women who are of childbearing age and not practicing adequate birth control.
  • Participation in another therapeutic trial in the previous 3 m onths
  • Stages 3 or m ore (Ficat and Arlet) or III or m ore (Steinberg) of severe fem oral head osteonecrosis,primarily based on diagnosis by im aging (X-Rays, MRI).
  • Flattening or collapse of the fem oral head (Steinberg stage IV) or articular cartilage collapse at the time of core decompression surgery.
  • Septic arthritis.
  • Stress fracture.
  • Non-osteonecrosis metabolic bone diseases (particularly Paget's disease of bone, osteogenesis imperfecta, primary hyperparathyroidism , fibrous dysplasia monostotic, polyostotic McCune-Albright syndrome] and osteopetrosis).
  • Any active bisphosphonate treatment or any history of intravenous (IV) treatment.
  • History of prior or concurrent diagnosis of HIV-, Hepatitis-B- or Hepatitis-C-infection
  • Active hepatitis B or hepatitis C infection at the time of screening.
  • Known allergies to products involved in the production process of MSC.
  • History of neoplasia or current neoplasia in any organ.
  • Corticoid or immunosuppressive therapy more than one week in the two months prior to study inclusion
  • Patients who will require continuous, systemic, high dose corticosteroid therapy (more than 7.5 m g/day) within 6 months after surgery.
  • Patients who are in active treatment for cancer or blood dyscrasia, or have received chemotherapy, radiotherapy or immunotherapy in the past 2 years.
  • History of regular alcohol consumption exceeding 2 drinks/day within 6 months of screening and/or history of illicit drug use.
  • Serum AST (SGO T)/ALT (SGPT) > 2.5 X (institutional standard range).
  • MRI-incompatible internal devices (pacemakers, aneurysm clips, etc).
  • Body mass index (BMI) of 40 kg/m ² or greater.
  • Patients unable to tolerate general anesthesia defined as an American Society of Anesthesiologists (ASA) criteria of > 2.
  • Insulin dependent diabetes
  • Patients with poorly controlled diabetes mellitus (HbA1C > 8%), or with peripheral neuropathy, or known concomitant vascular problems.
  • Patients receiving treatment with hematopoietic growth factors or anti-vasculogenesis or antiangiogenesis treatment.
  • Traumatic osteonecrosis.
  • Adult in the care of a guardian (Subject legally protected)
  • Im possibility to meet at the appointments for the clinical follow up.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Cultured autologous Mesenchymal Cells

Cultured Mesenchymal Cells from bone marrow isolation, expanded under GMP protocol in associated facilities and introduced at the end of the appropriate forage up to the femoral head under fluoroscopic control.

20x106 cells per cc in a single administration of 7cc
Biological: Cultured autologous Mesenchymal Cells
Cultured Mesenchymal Cells from bone marrow isolation, expanded under GMP protocol in associated facilities and introduced at the end of the appropriate forage up to the femoral head under fluoroscopic control.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Complication rate
Time Frame: 12 months
Includes early local complication rate plus global complication rate, as the percentage of patients with local or general complications at 52 weeks.
12 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
complication rate
Time Frame: 6,12,24,104 weeks
Local and general complication rate
6,12,24,104 weeks
Progression of disease to the next stage
Time Frame: 12 months
12 months
Amount of necrotic bone in the femoral head in MRI
Time Frame: 12 weeks and 52 weeks
12 weeks and 52 weeks
Pain (VAS)
Time Frame: 6,12,24,52,104 weeks
6,12,24,52,104 weeks
serum levels of bone turnover markers
Time Frame: 12 and 24 weeks
12 and 24 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Universidad Autonoma de Madrid

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Chair: Enrique Gomez-Barrena, Prof, Universidad Autonoma de Madrid, Hospital la Paz

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 1, 2014

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 1, 2016

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2017

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 12, 2014

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 14, 2014

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 17, 2014

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 14, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 5, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • ORTHO -2
  • 2012-002010-39 (EudraCT Number)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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