NCT01700920

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
3

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Jul 2012

Typical duration for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2012

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

October 2, 2012

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 4, 2012

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2015

Completed
Last Updated

March 30, 2017

Status Verified

March 1, 2017

Enrollment Period

3.4 years

First QC Date

October 2, 2012

Last Update Submit

March 29, 2017

Conditions

Osteonecrosis of the Femoral Head

Keywords

Osteonecrosis of the femoral headStem CellMesenchymal Stem CellsFemoral Head

Study Arms (1)

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.

Procedure: bone marrow aspirate

Interventions

bone marrow aspiratePROCEDURE
Mesenchymal Stem Cell

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital of Salamanca

Salamanca, Castille and León, 37007, Spain

Location

Related Links

MeSH Terms

Conditions

Legg-Calve-Perthes Disease

Condition Hierarchy (Ancestors)

Femur Head NecrosisOsteonecrosisBone DiseasesMusculoskeletal Diseases

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 2, 2012

First Posted

October 4, 2012

Study Start

July 1, 2012

Primary Completion

December 1, 2015

Study Completion

December 1, 2015

Last Updated

March 30, 2017

Record last verified: 2017-03

Locations

ES(1)