NCT00250302

Brief Summary

Mesenchymal stem cells are found in bone marrow, and have the ability to differentiate into different tissue types. The primary objective of the study is to examine the safety of using such cells to treat patients suffering from distal tibial shaft fractures. The cells will be isolated from the patient's bone marrow, loaded onto a carrier and implanted locally at the fracture site.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
24

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Apr 2009

Typical duration for phase_1

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

First Submitted

Initial submission to the registry

November 6, 2005

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 8, 2005

Completed
3.4 years until next milestone

Study Start

First participant enrolled

April 1, 2009

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2011

Completed
Last Updated

April 28, 2011

Status Verified

October 1, 2010

Enrollment Period

2 years

First QC Date

November 6, 2005

Last Update Submit

April 27, 2011

Conditions

Tibial Fracture

Outcome Measures

Primary Outcomes (2)

  • Safety

  • Number of patients reaching clinical union of fracture

Interventions

autologous mesenchymal stem cells implantationPROCEDURE

Eligibility Criteria

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

You may qualify if:

  • ages 18 and 65. males not involved in active military duty. females- non child bearing potential. distal tibia third fracture without joint involvement. fracture treated by IM nail, percutaneous plating or external fixation.

You may not qualify if:

  • active systemic or local infection. history of malignancy radiotherapy or chemotherapy. active autoimmune disease. any past or present immunosuppressive treatment. fracture treated by open reduction. fracture grade gustillo grade IIIB, IIC. use of steroids in past 6 months. chronic renal insufficiency. administration of marrow suppressive drugs. history of metabolic bone disease. administration of drugs that may interfere with bone metabolism.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hadassah Medical Organizaton

Jerusalem, Israel

Location

MeSH Terms

Conditions

Tibial Fractures

Condition Hierarchy (Ancestors)

Fractures, BoneWounds and InjuriesLeg Injuries

Study Officials

  • Meir Liebergall, Prof.

    Hadassah Medical Organization

    PRINCIPAL INVESTIGATOR

  • Rami Mosheiff, Prof.

    Hadassah Medical Organization

    STUDY DIRECTOR

  • Dan Gazit, Prof.

    Hebrew University

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

November 6, 2005

First Posted

November 8, 2005

Study Start

April 1, 2009

Primary Completion

April 1, 2011

Study Completion

April 1, 2011

Last Updated

April 28, 2011

Record last verified: 2010-10

Locations

IL(1)