Human Embryonic Stem Cell-Derived Cardiomyocyte Therapy for Chronic Ischemic Left Ventricular Dysfunction

Conditions

• Chronic Ischemic Left Ventricular Dysfunction

Eligibility Criteria

Sex

ALL

Age

21 Years - 80 Years

Healthy Volunteers

Not accepted

Interventions

• Human Embryonic Stem Cell-Derived Cardiomyocyte 50M cells — DRUG
  50 million (M) cells delivered in a dose of 5M cells per injection over 10 injections.
• Human Embryonic Stem Cell-Derived Cardiomyocyte 150 cells — DRUG
  150M cells delivered in a dose of 15M cells per injection over 10 injections
• Human Embryonic Stem Cell-Derived Cardiomyocyte 300M cells — DRUG
  300M cells delivered in a dose of 30M per injection over 10 injections

Study Details

This clinical study will utilize a new cell therapy approach (Human embryonic stem cells derived cardiomyocytes or hESC-CMs) to improve survival and cardiac function in patients with chronic left ventricular dysfunction secondary to MI (Myocardial Infarction).

Key Dates

Start date

Mar 22, 2022

Status verified

Sep 2025

Primary completion

Oct 31, 2028

Completion

Oct 31, 2028

Study Design

Enrollment

18 participants (estimated)

Allocation

RANDOMIZED

Intervention model

SEQUENTIAL

Primary purpose

TREATMENT

Arms

• Active Comparator: Cohort 1
  Low dose (50M cells)
• Active Comparator: Cohort 2
  Medium dose (150M cells)
• Active Comparator: Cohort 3
  High dose (300M cells)

Primary Outcome Measure

The maximum tolerated dose (MTD) among 3 dose levels of allogeneic human embryonic stem cell-derived cardiomyocytes (hESC-CMs) [ Time Frame: 3 Years ]

Central Contacts

• Joseph C. Wu, MD, PhD
  (650) 736-2246
  [email protected]
• Evgenios Neofytou, MD
  (650) 736-2246
  [email protected]

Locations (1)

Find similar trials in Palo Alto, CA