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NBS10

Phase 2

ST Segment Elevation Myocardial Infarction | Monoclonal antibody | Cardiovascular |Lisata Therapeutics, Inc.|Trials Updated: Apr 28, 2016

NBS10 development status

Highest phase Phase 2
Registered trials 1 across 1 sponsor since Dec 2011

NBS10 target and mechanism

Molecular targetCD34
Target classCell Surface Protein
ModalityMonoclonal antibody

Also known as AMR-001

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLEDDMC
Total Trials1
Total Enrollment195

FDA Designations

No designations recorded

NBS10 clinical trials

NBS10 · 1 trial · 1 indication

Phase 2 1
NCT01495364NBS10 (Also Known as AMR-001) Versus Placebo Post ST Segment Elevation Myocardial InfarctionST Segment Elevation Myocardial Infarction
COMPLETED195 Analytics
PHASE2COMPLETED
NBS10 (Also Known as AMR-001) Versus Placebo Post ST Segment Elevation Myocardial Infarction
ST Segment Elevation Myocardial InfarctionUnlock trial analytics

Study Endpoints

Primary Endpoints

To determine safety and efficacy of intracoronary infusion of NBS10.
primary outcome measured at 6 months

The primary endpoint includes the occurrence of AE's, SAE's and Major Adverse Cardiac Events (MACE) and the assessment of myocardial perfusion measured by quantitative gated SPECT MPI specifically looking at resting total severity score.

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Study Design & Arms

AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
NBS10EXPERIMENTALactive treatment - CD34+ cells
placeboPLACEBO_COMPARATORmatching placebo

Interventions

NameTypeDescription
NBS10BIOLOGICALdosage = 10 or more million CD34+ cells via intracoronary infusion
placeboOTHERmatching placebo
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites58

Inclusion Criteria: 1. Age 18 years or older. 2. Acute ST elevation myocardial infarction meeting ACC/AHA criteria, with symptoms of chest pain within 3 days of admission. Criteria include (ST elevation \> 1mm in limb leads or 2 mm in two or more precordial leads, and increased levels of troponin, ...

Countries:United States
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Frequently asked questions about NBS10

What is NBS10?

NBS10 is an investigational monoclonal antibody developed by Lisata Therapeutics, Inc. (ticker LSTA) for the treatment of ST Segment Elevation Myocardial Infarction, a type of heart attack. It is a Phase 2 cardiovascular therapy and is not approved for commercial use.

What is NBS10 used for in ST Segment Elevation Myocardial Infarction?

NBS10 is being developed for use after ST Segment Elevation Myocardial Infarction, commonly known as a heart attack. The goal is to support cardiac repair following the event. It remains investigational and has not been approved for any indication.

What does NBS10 target?

NBS10 targets CD34, a cell surface protein. CD34 is a marker found on certain progenitor cells. By binding CD34, NBS10 is designed to interact with these cells as part of its therapeutic approach in cardiovascular repair after myocardial infarction.

Who is developing NBS10?

NBS10 is being developed by Lisata Therapeutics, Inc., which trades under the ticker LSTA. The company is responsible for the clinical program evaluating NBS10 in cardiovascular disease.

What phase is NBS10 in?

NBS10 is in Phase 2 clinical development. It is an investigational therapy and has not received FDA approval. The Phase 2 trial has been completed, and no active trials are currently listed for this asset.

What clinical trials is NBS10 in?

NBS10 has been studied in one completed Phase 2 trial, NCT01495364, titled NBS10 (Also Known as AMR-001) Versus Placebo Post ST Segment Elevation Myocardial Infarction. The randomized, double-blind, placebo-controlled trial enrolled 195 participants in the United States.

Is NBS10 the same as AMR-001?

Yes, NBS10 is also known as AMR-001. The Phase 2 trial NCT01495364 used both names in its title, confirming they refer to the same investigational monoclonal antibody developed by Lisata Therapeutics for ST Segment Elevation Myocardial Infarction.