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Single Dose MPCs

Phase 2

Degenerative Disc Disease | Monoclonal antibody | Musculoskeletal |Mesoblast Limited|Last Updated: Jun 26, 2020

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLEDDMC
Total Trials1
Total Enrollment100

FDA Designations

No designations recorded

Clinical trial landscape

Single Dose MPCs · 1 trial · 1 indication

Phase 2 1
NCT01290367Safety and Preliminary Efficacy Study of Mesenchymal Precursor Cells (MPCs) in Subjects With Lumbar Back PainDegenerative Disc Disease
COMPLETED100 Analytics
PHASE2COMPLETED
Safety and Preliminary Efficacy Study of Mesenchymal Precursor Cells (MPCs) in Subjects With Lumbar Back Pain
Degenerative Disc DiseaseUnlock trial analytics

Study Endpoints

Primary Endpoints

To determine the overall safety of MPCs 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).
3 years

Secondary Endpoints

To evaluate the change of treated lumbar intervertebral discs using Magnetic Resonance Imaging (MRI) at 6 months post injection of MPCs.
6 - 36 Months
To evaluate the effectiveness of MPCs in reducing chronic lumbar back pain using the visual analog scale (VAS).
1 - 36 Months
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Study Design & Arms

AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
High Dose MPCsEXPERIMENTALInjection of High Dose MPCs with Hyaluronic Acid
Low Dose MPCsEXPERIMENTALInjection of Low Dose MPCs with Hyaluronic Acid
Saline injectionSHAM_COMPARATORInjection of saline solution.
Hyaluronic acid injectionPLACEBO_COMPARATORInjection of hyaluronic acid solution

Interventions

NameTypeDescription
Single Dose MPCs InjectionBIOLOGICALInjection of Low Dose MPCs with Hyaluronic Acid into the degenerated lumbar disc's nucleus pulposus.
Single injection of saline solutionPROCEDUREIntradiscal control injection with saline solution
Single injection of hyaluronic acidPROCEDUREIntradiscal control injection with hyaluronic acid
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites14

Inclusion Criteria: 1. Male or females at least 18 years of age. 2. Have the ability to understand the requirements of the study, to provide written informed consent, and to comply with the study protocol. 3. Have the ability to understand and provide written authorization for the use and disclosur...

Countries:United StatesAustralia
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Frequently asked questions about Single Dose MPCs

What is Single Dose MPCs used for in Degenerative Disc Disease?

Single Dose MPCs is an investigational therapy being studied for the treatment of Degenerative Disc Disease, a condition that causes lumbar back pain. It is a mesenchymal precursor cell product developed by Mesoblast Limited. The therapy is currently in Phase 2 clinical development and has not been approved by regulatory authorities.

What does Single Dose MPCs target?

Single Dose MPCs is a cell therapy that uses mesenchymal precursor cells (MPCs) to target degenerative disc disease. These cells are intended to modulate the inflammatory environment and promote tissue repair within the intervertebral disc. The therapy is being evaluated for its safety and preliminary efficacy in reducing lumbar back pain associated with disc degeneration.

Who makes Single Dose MPCs?

Single Dose MPCs is being developed by Mesoblast Limited, a biopharmaceutical company listed on the NASDAQ under the ticker symbol MESO. Mesoblast specializes in cell-based medicines and is conducting clinical trials to evaluate the safety and efficacy of this therapy for degenerative disc disease.

What phase is Single Dose MPCs in?

Single Dose MPCs is in Phase 2 clinical development. It is an investigational therapy and has not yet been approved by the FDA or other regulatory agencies. The Phase 2 trial has been completed, and the results will inform whether the therapy advances to later-stage clinical trials.

What clinical trials is Single Dose MPCs in?

Single Dose MPCs has been studied in one completed Phase 2 clinical trial, identified by the identifier NCT01290367. This trial was titled 'Safety and Preliminary Efficacy Study of Mesenchymal Precursor Cells (MPCs) in Subjects With Lumbar Back Pain' and enrolled 100 participants with Degenerative Disc Disease in the United States and Australia.

Is Single Dose MPCs the same as MPCs?

Single Dose MPCs refers to a specific dosing regimen of mesenchymal precursor cells (MPCs) developed by Mesoblast. The clinical trial NCT01290367 evaluated the safety and preliminary efficacy of MPCs in subjects with lumbar back pain. The term 'Single Dose' indicates that the therapy is administered as a single injection, as opposed to multiple doses.