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Mesenchymal Stem Cells

Phase 3

Recovery Following Partial Medial Meniscectomy | Cell therapy | Musculoskeletal |Mesoblast Limited|Trials Updated: Dec 27, 2021

Mesenchymal Stem Cells development status

Highest phase Phase 3 (NCT01233960)
Phase scored for MESOPhase 1
Registered trials 10 across 4 sponsors since Sep 2005

Mesenchymal Stem Cells target and mechanism

ModalityCell therapy

Also known as Prochymal®

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindACTIVE_CONTROLLED
Total Trials1
Total Enrollment60

FDA Designations

No designations recorded

Mesenchymal Stem Cells clinical trials

Mesenchymal Stem Cells · 1 trial · 1 indication

Phase 1 1
NCT00225095A Phase I/II Study of Chondrogen Delivered by Intra-Articular Injection Following MeniscectomyRecovery Following Partial Medial Meniscectomy
COMPLETED60 Analytics
PHASE1COMPLETED
A Phase I/II Study of Chondrogen Delivered by Intra-Articular Injection Following Meniscectomy
Recovery Following Partial Medial MeniscectomyUnlock trial analytics

Study Endpoints

Primary Endpoints

Meniscal Volume
6 months

Changes in meniscal volume over the course of the study as determined by MRI

Secondary Endpoints

Quality of Life Questionnaire
2 years
Visual Analog Scale (VAS)
Baseline to 2 years
Lysholm Knee Scale
2 years
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Study Design & Arms

AllocationRANDOMIZED
MaskingTRIPLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Chondrogen - dose 1ACTIVE_COMPARATORChondrogen - 50 million cells
Chondrogen - dose 2ACTIVE_COMPARATORChondrogen - 150 million cells
Vehicle ControlOTHERVehicle Control

Interventions

NameTypeDescription
Mesenchymal Stem CellsDRUG -
HyaluronanDRUG -
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Eligibility Criteria

Age Range18 Years to 60 Years
SexALL
Healthy VolunteersNo
Study Sites8

Inclusion Criteria: * Age 18 to 60, inclusive * In need of medial meniscectomy * Normal axial alignment * Stable knee- previous ligament reconstruction, if stable * Removal of at least 50% of the affected portion of the medial meniscus * Intact articular cartilage in posterior meniscal weight-beari...

Countries:United States
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Frequently asked questions about Mesenchymal Stem Cells

What is Mesenchymal Stem Cells used for?

Mesenchymal Stem Cells, developed by Mesoblast Limited, is being studied for recovery following partial medial meniscectomy, a knee surgery that removes part of a torn meniscus. The investigational cell therapy is intended to support healing after this procedure. It has been evaluated in a single completed Phase 1/2 clinical trial.

Who is developing Mesenchymal Stem Cells?

Mesenchymal Stem Cells is being developed by Mesoblast Limited, which trades under the ticker MESO. The company is the sponsor of the clinical program evaluating this cell therapy for recovery following partial medial meniscectomy.

What phase is Mesenchymal Stem Cells in?

Mesenchymal Stem Cells is in Phase 1 development. The program has one completed Phase 1/2 trial, and there are no active trials at this time. It is an investigational therapy and has not been approved by the FDA for any indication.

What clinical trials is Mesenchymal Stem Cells in?

Mesenchymal Stem Cells has been studied in one completed clinical trial, NCT00225095, titled A Phase I/II Study of Chondrogen Delivered by Intra-Articular Injection Following Meniscectomy. The trial enrolled 60 participants in the United States and evaluated recovery following partial medial meniscectomy.

How was the Mesenchymal Stem Cells trial designed?

The Phase 1/2 trial NCT00225095 was a randomized, double-blind, active-controlled study. It enrolled 60 participants aged 18 years and older of all sexes in the United States. The trial evaluated intra-articular injection of the cell therapy following partial medial meniscectomy and has been completed.