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Chondrogen

Phase 1

Recovery Following Partial Medial Meniscectomy | Small molecule | Musculoskeletal |Mesoblast Limited|Last Updated: Jan 11, 2022

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials1
Total Enrollment55

FDA Designations

No designations recorded

Clinical trial landscape

Chondrogen · 1 trial · 1 indication

Phase 1 1
NCT00702741Follow-up Study of Chondrogen® Delivered by Intra-Articular Injection Following MeniscectomyRecovery Following Partial Medial Meniscectomy
COMPLETED55 Analytics
PHASE1COMPLETED
Follow-up Study of Chondrogen® Delivered by Intra-Articular Injection Following Meniscectomy
Recovery Following Partial Medial MeniscectomyUnlock trial analytics

Study Endpoints

Primary Endpoints

Comparison of treatment adverse event rates
Through 3 years

Secondary Endpoints

Concomitant Medications
Through 3 years
Visual Analog Scale
Through 3 years
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Study Design & Arms

AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
AEXPERIMENTALChondrogen (low dose)
BEXPERIMENTALChondrogen (high dose)
CPLACEBO_COMPARATORHyaluronan

Interventions

NameTypeDescription
ChondrogenDRUGIntra-articular injection of ex vivo cultured adult human mesenchymal stem cells
PlaceboDRUGIntra-articular injection of Hyaluronan
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Eligibility Criteria

Age Range18 Years to 60 Years
SexALL
Healthy VolunteersNo
Study Sites4

Inclusion Criteria: * Subject must have received an injection in Protocol No. 550 * Subject must have completed the 6-month and final 2-year visit in Protocol No. 550 * Subject must provide written informed consent for entry into the extension study * Subject must provide authorization for use and ...

Countries:United States
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Frequently asked questions about Chondrogen

What is Chondrogen used for?

Chondrogen is an investigational small molecule being studied for recovery following partial medial meniscectomy, a surgical procedure on the knee. It is delivered by intra-articular injection directly into the joint. The drug is in Phase 1 clinical development and is not yet approved by the FDA.

Who makes Chondrogen?

Chondrogen is being developed by Mesoblast Limited, a biopharmaceutical company traded on the NASDAQ under the ticker symbol MESO. Mesoblast is conducting clinical trials to evaluate the safety and efficacy of Chondrogen for patients recovering from partial medial meniscectomy.

What phase is Chondrogen in?

Chondrogen is currently in Phase 1 clinical development. It has completed one Phase 1 trial, which was a randomized, double-blind, placebo-controlled study. The drug is investigational and has not received FDA approval. Further clinical studies would be needed to assess its safety and effectiveness.

What clinical trials is Chondrogen in?

Chondrogen has been studied in one completed clinical trial, registered as NCT00702741. This Phase 1 study, titled 'Follow-up Study of Chondrogen® Delivered by Intra-Articular Injection Following Meniscectomy,' enrolled 55 participants in the United States. The trial was randomized, double-blind, and placebo-controlled, and it has been completed.

How is Chondrogen administered?

Chondrogen is administered by intra-articular injection, meaning it is injected directly into the knee joint. This route of administration is used in the clinical trial for patients recovering from partial medial meniscectomy. The drug is being evaluated as a potential treatment to aid in recovery following this surgical procedure.