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autologous mesenchymal stem cells implantation

Phase 1

Tibial Fracture | Unknown | Musculoskeletal |Teva Pharmaceutical Industries Limited|Last Updated: Apr 28, 2011

Success Probability

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Market & Valuation

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Trial Design

RandomizedUNCONTROLLEDBiomarker
Total Trials1
Total Enrollment24

FDA Designations

No designations recorded

Clinical trial landscape

autologous mesenchymal stem cells implantation · 1 trial · 1 indication

Phase 1 1
NCT00250302Autologous Implantation of Mesenchymal Stem Cells for the Treatment of Distal Tibial FracturesTibial Fracture
COMPLETED24 Analytics
PHASE1COMPLETED
Autologous Implantation of Mesenchymal Stem Cells for the Treatment of Distal Tibial Fractures
Tibial FractureUnlock trial analytics

Study Endpoints

Primary Endpoints

Safety
Number of patients reaching clinical union of fracture
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Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT

Interventions

NameTypeDescription
autologous mesenchymal stem cells implantationPROCEDURE -
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Eligibility Criteria

Age Range18 Years to 65 Years
SexALL
Healthy VolunteersNo
Study Sites1

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 inf...

Countries:Israel
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Frequently asked questions about autologous mesenchymal stem cells implantation

What is autologous mesenchymal stem cells implantation used for?

Autologous mesenchymal stem cells implantation is an investigational cell therapy being studied for the treatment of tibial fracture, specifically distal tibial fractures. It involves implanting a patient's own mesenchymal stem cells to support bone healing. The therapy is in Phase 1 clinical development and is not yet approved by regulatory authorities.

Who is developing autologous mesenchymal stem cells implantation?

Autologous mesenchymal stem cells implantation is being developed by Teva Pharmaceutical Industries Limited, a company listed on the stock exchange under the ticker TEVA. The therapy is currently in Phase 1 clinical development for the treatment of tibial fracture.

What phase is autologous mesenchymal stem cells implantation in?

Autologous mesenchymal stem cells implantation is in Phase 1 clinical development. It is an investigational therapy and has not been approved by regulatory authorities. A Phase 1 clinical trial for the treatment of tibial fracture has been completed.

What clinical trials is autologous mesenchymal stem cells implantation in?

Autologous mesenchymal stem cells implantation has one completed clinical trial, identified as NCT00250302, titled 'Autologous Implantation of Mesenchymal Stem Cells for the Treatment of Distal Tibial Fractures.' This Phase 1 trial enrolled 24 participants with tibial fracture in Israel and was not blinded or controlled.

Is autologous mesenchymal stem cells implantation the same as mesenchymal stem cell therapy?

Autologous mesenchymal stem cells implantation is a specific form of mesenchymal stem cell therapy. The term 'autologous' indicates that the stem cells are derived from the patient's own body, rather than from a donor. This approach is being studied for its potential to treat tibial fractures.