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MSB-CAR001 Combined With Hyaluronan

Phase 1

Anterior Cruciate Ligament Injury | Monoclonal antibody | Musculoskeletal |Mesoblast Limited|Last Updated: Aug 15, 2018

Success Probability

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Trial Design

RandomizedDouble-BlindACTIVE_CONTROLLEDDMC
Total Trials1
Total Enrollment17

FDA Designations

No designations recorded

Clinical trial landscape

MSB-CAR001 Combined With Hyaluronan · 1 trial · 2 indications

Phase 1 1
NCT01088191Safety and Efficacy Study of MSB-CAR001 in Subjects 6 Weeks Post an Anterior Cruciate Ligament ReconstructionAnterior Cruciate Ligament Injury
COMPLETED17 Analytics
PHASE1COMPLETED
Safety and Efficacy Study of MSB-CAR001 in Subjects 6 Weeks Post an Anterior Cruciate Ligament Reconstruction
Anterior Cruciate Ligament Injury
NCT0108819117
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Study Endpoints

Primary Endpoints

To determine the overall safety of MSB-CAR001 plus carrier using physical examinations, vital signs, treatment emergent adverse events (TEAEs), and the results of clinical lab tests (hematology, serum chemistry, inflammation, and immunology).
2 years

Secondary Endpoints

To evaluate the overall efficacy with MSB-CAR001 plus Hyaluronan compared to Hyaluronan alone using MRI scans and x-ray of the involved knee joint and access the change in outcomes (KOOS, SF-36) and pain (VAS)
2 years
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Study Design & Arms

AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Hyaluronan AloneACTIVE_COMPARATORHyaluronan Alone
MSB-CAR001EXPERIMENTALSingle Dose of MSB-CAR001 Combined With Hyaluronan

Interventions

NameTypeDescription
MSB-CAR001 Combined With HyaluronanBIOLOGICALKnee Injection of Biological: MSB-CAR001 Combined With Hyaluronan Single Injection Into the Knee Joint of Single Doses of MSB-CAR001 Combined With Hyaluronan
HyaluronanDRUGHyaluronan alone
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Eligibility Criteria

Age Range18 Years to 40 Years
SexALL
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: 1. Males or females at least 18 years of age, but not older than 40 2. ACL injury requiring reconstruction 3. Have undergone unilateral ACL reconstruction surgery within six months of injury; 4. Willing and able to undertake a standardized rehabilitation protocol 5. ACL graft us...

Countries:Australia
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Frequently asked questions about MSB-CAR001 Combined With Hyaluronan

What is MSB-CAR001 Combined With Hyaluronan used for?

MSB-CAR001 Combined With Hyaluronan is an investigational therapy being studied for the treatment of anterior cruciate ligament injury. It is being evaluated in patients who are 6 weeks post an anterior cruciate ligament reconstruction, with the condition also associated with osteoarthritis.

Who is developing MSB-CAR001 Combined With Hyaluronan?

MSB-CAR001 Combined With Hyaluronan is being developed by Mesoblast Limited, a biopharmaceutical company. Mesoblast's stock is traded under the ticker symbol MESO.

What phase is MSB-CAR001 Combined With Hyaluronan in?

MSB-CAR001 Combined With Hyaluronan is in Phase 1 clinical development. It is an investigational drug and has not been approved by regulatory authorities. The therapy is being studied for its safety and efficacy in patients with anterior cruciate ligament injury.

What clinical trials is MSB-CAR001 Combined With Hyaluronan in?

MSB-CAR001 Combined With Hyaluronan has been studied in one clinical trial, identified as NCT01088191. This was a Phase 1, randomized, double-blind, active-controlled study that evaluated the safety and efficacy of the therapy in subjects 6 weeks post an anterior cruciate ligament reconstruction. The trial has been completed.

Is MSB-CAR001 Combined With Hyaluronan the same as MSB-CAR001?

MSB-CAR001 Combined With Hyaluronan is a combination therapy that includes MSB-CAR001 and hyaluronan. The clinical trial NCT01088191 evaluated this combination in patients with anterior cruciate ligament injury. The trial enrolled 17 participants and was conducted in Australia.