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Mesenchymal stem cells

Phase 1

Chronic Myocardial Ischemia | Gene therapy | Cardiovascular |Establishment Labs Holdings Inc.|Last Updated: Sep 19, 2014

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLEDDMC
Total Trials1
Total Enrollment10

FDA Designations

No designations recorded

Clinical trial landscape

Mesenchymal stem cells · 1 trial · 2 indications

Phase 1 1
NCT01076920Mesenchymal Stem Cells and Myocardial IschemiaChronic Myocardial Ischemia
COMPLETED10 Analytics
PHASE1COMPLETED
Mesenchymal Stem Cells and Myocardial Ischemia
Chronic Myocardial Ischemia
NCT0107692010
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Study Endpoints

Primary Endpoints

Evaluate safety and feasibility of transendocardial injection using the NogaStar XP Mapping Catheter with the MyostarTM Left Ventricular Injection Catheter of autologous MSC in subjects with chronic myocardial ischemia and left ventricular dysfunction
30 days

Secondary Endpoints

Change from baseline in SF-36, VO2max, 6 min walk test, and the NYHA, CCS Classifications Effect related to cardiac function
30 days to 2 years
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Study Design & Arms

AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Intervention armEXPERIMENTAL -

Interventions

NameTypeDescription
Mesenchymal stem cellsGENETIC60x106 MSCs Trans-endocardial intramyocardial injections (n=14-16)
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: 1. Age 18 to 75 2. Male or female 3. NYHA (Heart failure) Class II-IV or Angina pectoris CCS Class III or IV or symptoms consistent with) 4. Chronic coronary artery disease with left ventricular function below 35% 5. Stable medical therapy for at least one month 6. Reversible pe...

Countries:France
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Frequently asked questions about Mesenchymal stem cells

What is Mesenchymal stem cells used for?

Mesenchymal stem cells are being studied for the treatment of Chronic Myocardial Ischemia, a condition involving reduced blood flow to the heart muscle. The investigational therapy is also associated with Left Ventricular Dysfunction. It is currently in Phase 1 clinical development for this cardiovascular indication.

Who makes Mesenchymal stem cells?

Mesenchymal stem cells are being developed by Establishment Labs Holdings Inc., a company traded on the stock exchange under the ticker symbol ESTA. The therapy is in Phase 1 clinical development for the treatment of Chronic Myocardial Ischemia.

What phase is Mesenchymal stem cells in?

Mesenchymal stem cells are in Phase 1 clinical development. The therapy is investigational and has not been approved by regulatory authorities. A Phase 1 clinical trial has been completed, with results not yet reported as part of the available data.

What clinical trials is Mesenchymal stem cells in?

Mesenchymal stem cells have one completed clinical trial, identified as NCT01076920, titled 'Mesenchymal Stem Cells and Myocardial Ischemia'. This Phase 1 study enrolled 10 participants with Chronic Myocardial Ischemia and Left Ventricular Dysfunction in France. The trial was uncontrolled and not randomized or blinded.

Is Mesenchymal stem cells a gene therapy?

Yes, Mesenchymal stem cells is classified as a gene therapy modality. It is being investigated for the treatment of Chronic Myocardial Ischemia, a cardiovascular condition. The therapy is in Phase 1 clinical development, with one completed trial involving 10 participants.