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Mesenchymal Precursor Cells

Phase 1

Diabetic Nephropathy | Monoclonal antibody | Metabolic |Mesoblast Limited|Trials Updated: Jun 2, 2020

Mesenchymal Precursor Cells target and mechanism

ModalityMonoclonal antibody

Also known as Mesenchymal Precursor Cells (MPCs)

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindCONTROLLEDDMC
Total Trials3
Total Enrollment151

FDA Designations

No designations recorded

Mesenchymal Precursor Cells clinical trials

Mesenchymal Precursor Cells · 3 trials · 3 indications

Phase 2 1Phase 1 2
NCT00721045A Phase II Dose-escalation Study to Assess the Feasibility and Safety of Transendocardial Delivery of Three Different Doses of Allogeneic Mesenchymal Precursor Cells (MPCs)in Subjects With Heart FailureHeart Failure
COMPLETED60 Analytics
PHASE2COMPLETED
A Phase II Dose-escalation Study to Assess the Feasibility and Safety of Transendocardial Delivery of Three Different Doses of Allogeneic Mesenchymal Precursor Cells (MPCs)in Subjects With Heart Failure
Heart FailureUnlock trial analytics

Study Endpoints

Primary Endpoints

The primary objective of this study is to evaluate the feasibility and safety of transendocardial injection using mapping Catheter with the Left Ventricular Injection Catheter of 25 M, 75 M, and 150 M allogeneic MPCs in subjects with heart failure.
3 years
The primary objective of the study is to assess the safety and tolerability of MPC therapy
60 Weeks

Outcomes include the following safety parameters: * Number of and percent of subject with adverse events and serious adverse events * Clinically significant values and shifts from baseline in vital signs, physical examinations and electrocardiograms * Clinical laboratory tests (hematology, chemistry and urinalysis, flow cytometry with Class I and Class II PRA % with specificity)

Primary objective of the study is to assess the safety and tolerability of MPC therapy
116 Weeks

Outcomes include the measurement of the following safety parameters: * Adverse events and serious adverse events(including hypoglycemia) * Vital signs (BP, HR, RR, O2 saturation) * Physical examinations * Results of clinical laboratory tests (hematology, biochemistry, and urinalysis, flow cytometry Class I and Class II PRA % with specificity, antibovine and antimurine antibody analysis) * Pulmonary function test * Electrocardiograms * Chest X-ray * Fundus oculi examination

Secondary Endpoints

The secondary objectives are to explore functional efficacy for subsequent study design.
3 years
Exploratory assessment of the efficacy of MPC therapy
12 Weeks
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Study Design & Arms

AllocationRANDOMIZED
MaskingSINGLE
ModelFACTORIAL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
A1ACTIVE_COMPARATOR15 subjects randomized to receive 25 M allogeneic MPCs by transendocardial injection and mapping.
A2SHAM_COMPARATOR5 subjects randomized to receive standard-of-care treatment with mock mapping and injection procedures.
B1ACTIVE_COMPARATOR15 subjects randomized to receive 75 M allogeneic MPCs by transendocardial injection and mapping.
B2SHAM_COMPARATOR5 subjects randomized to receive standard-of-care treatment with mock mapping and injection procedures.
C1ACTIVE_COMPARATOR15 subjects randomized to receive 150 M allogeneic MPCs by transendocardial injection and mapping.
C2SHAM_COMPARATOR5 subjects randomized to receive standard-of-care treatment with mock mapping and injection procedures.
Cohort 1EXPERIMENTALMesenchymal Precursor Cells (MPCs) - Dose 1 or Placebo
Cohort 2EXPERIMENTALMesenchymal Precursor Cells (MPCs) - Dose 2 or Placebo
Cohort 3EXPERIMENTALMPC dose 3 or Placebo

Interventions

NameTypeDescription
Mesenchymal Precursor Cells (MPCs)BIOLOGICAL25 M allogeneic MPCs by transendocardial injection and mapping.
standard-of-care treatment with mock mapping and injection procedures.PROCEDUREMock
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Eligibility Criteria

Age Range20 Years to 80 Years
SexALL
Healthy VolunteersNo
Study Sites6

Inclusion Criteria: 1. NYHA ≥ 2. 2. Age \>20 and \<80. 3. Cardiomyopathy of ischemic or idiopathic etiology. 4. Subject is not a candidate for either percutaneous intervention or cardiac surgery as determined by both an interventional cardiologist and a cardiac surgeon. 5. LVEF (Left ventricular ej...

Countries:United StatesAustralia
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Competitive Landscape -Diabetic Nephropathy 12 trials

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Frequently asked questions about Mesenchymal Precursor Cells

What is Mesenchymal Precursor Cells used for?

Mesenchymal Precursor Cells are being studied for diabetic nephropathy, heart failure, and type 2 diabetes. The clinical program includes a Phase 1 trial in diabetic nephropathy and type 2 diabetes, a Phase 1 trial in type 2 diabetes, and a Phase 2 trial in heart failure. All three trials have been completed.

Who is developing Mesenchymal Precursor Cells?

Mesenchymal Precursor Cells are being developed by Mesoblast Limited, which trades under the ticker MESO. The company is the sponsor of the clinical program evaluating this cell-based therapy across metabolic and cardiovascular indications.

What phase is Mesenchymal Precursor Cells in?

Mesenchymal Precursor Cells are in clinical development, with completed Phase 1 and Phase 2 trials. The program includes two Phase 1 studies and one Phase 2 study. No active trials are currently listed, and the asset has not been approved by the FDA.

What clinical trials are testing Mesenchymal Precursor Cells?

Three completed trials have evaluated Mesenchymal Precursor Cells: NCT01843387 in diabetic nephropathy and type 2 diabetes, NCT01576328 in type 2 diabetes, and NCT00721045 in heart failure. The heart failure study used transendocardial delivery and was a Phase 2 dose-escalation trial.

Is Mesenchymal Precursor Cells the same as MPCs?

Yes, Mesenchymal Precursor Cells are also known as MPCs. The abbreviation MPCs is used in trial titles and scientific literature to refer to the same allogeneic cell therapy developed by Mesoblast Limited.