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Single Dose MPCs

Phase 2

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

Single Dose MPCs target and mechanism

ModalityMonoclonal antibody

Also known as Single Dose MPCs Injection

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

Single Dose MPCs clinical trials

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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Competitive Landscape -Degenerative Disc Disease 14 trials

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Frequently asked questions about Single Dose MPCs

What is Single Dose MPCs?

Single Dose MPCs is an investigational cell-based therapy developed by Mesoblast Limited for degenerative disc disease, a musculoskeletal condition that causes lumbar back pain. It is given as a single injection and has been studied in a Phase 2 clinical trial. It is not an approved treatment.

What is Single Dose MPCs used for in degenerative disc disease?

Single Dose MPCs is being developed to treat degenerative disc disease, specifically for patients with lumbar back pain. The goal is to provide a single-dose injection that may relieve pain associated with disc degeneration. It remains investigational and has not been approved for any use.

Who makes Single Dose MPCs?

Single Dose MPCs is developed by Mesoblast Limited, an Australian regenerative medicine company. Mesoblast trades on the Nasdaq under the ticker MESO. The company is responsible for the clinical development of this cell therapy candidate.

What phase is Single Dose MPCs in?

Single Dose MPCs is in Phase 2 clinical development. The only reported trial for this candidate is a completed Phase 2 study. It is an investigational product and has not received FDA approval.

What clinical trials is Single Dose MPCs in?

Single Dose MPCs has been evaluated in one completed Phase 2 trial, NCT01290367, titled "Safety and Preliminary Efficacy Study of Mesenchymal Precursor Cells (MPCs) in Subjects With Lumbar Back Pain." The trial enrolled 100 participants with degenerative disc disease across the United States and Australia.

Is Single Dose MPCs the same as Single Dose MPCs Injection?

Yes, Single Dose MPCs Injection is another name for Single Dose MPCs. Both refer to the same investigational cell therapy developed by Mesoblast Limited for degenerative disc disease. The terms are used interchangeably in reference to this product candidate.