Autologous Implantation of Mesenchymal Stem Cells for the Treatment of Distal Tibial Fractures
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ClinicalTrials.gov Identifier: NCT00250302 |
Recruitment Status :
Completed
First Posted : November 8, 2005
Last Update Posted : April 28, 2011
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Tibial Fracture | Procedure: autologous mesenchymal stem cells implantation | Phase 1 Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 24 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | Autologous Implantation of Mesenchymal Stem Cells for the Treatment of Distal Tibial Fractures |
Study Start Date : | April 2009 |
Actual Primary Completion Date : | April 2011 |
Actual Study Completion Date : | April 2011 |

- Safety
- Number of patients reaching clinical union of fracture

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Ages Eligible for Study: | 18 Years to 65 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00250302
Israel | |
Hadassah Medical Organizaton | |
Jerusalem, Israel |
Principal Investigator: | Meir Liebergall, Prof. | Hadassah Medical Organization | |
Study Director: | Rami Mosheiff, Prof. | Hadassah Medical Organization | |
Study Chair: | Dan Gazit, Prof. | Hebrew University |
ClinicalTrials.gov Identifier: | NCT00250302 |
Other Study ID Numbers: |
AMSC-01-HMO-CTIL |
First Posted: | November 8, 2005 Key Record Dates |
Last Update Posted: | April 28, 2011 |
Last Verified: | October 2010 |
Fractures, Bone Tibial Fractures Wounds and Injuries Leg Injuries |