STM01 for Heart Failure

Phase 1

Waitlist Available

Research Sponsored by Secretome Therapeutics

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Adequate bone marrow reserve and organ function at the Screening

Be older than 18 years old

Must not have

Prior diagnosis of hypertrophic cardiomyopathy or a known infiltrative or storage disorder causing HFpEF and/or cardiac hypertrophy, such as amyloidosis, Fabry disease, or Noonan syndrome with LV hypertrophy

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing the safety and tolerability of STM-01 in people with heart failure with preserved ejection fraction.

Who is the study for?

This trial is for individuals with a condition called Heart Failure with Preserved Ejection Fraction (HFpEF). Specific eligibility criteria are not provided, but typically participants must meet certain health standards and may be required to have a specific range of heart function.

What is being tested?

The study is testing the safety and tolerability of multiple doses of a new medication named STM01 in people who have HFpEF. It's an early-stage (Phase 1) trial where researchers observe how participants respond to increasing amounts of the drug.

What are the potential side effects?

Since this is a Phase 1 trial primarily focused on safety, detailed side effects are not listed. However, common side effects in such trials can include nausea, headaches, dizziness, or other reactions depending on the nature of STM01.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My organs and bone marrow are functioning well.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have been diagnosed with a condition causing thickened heart muscles or HFpEF.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Dose arm (3 cohorts; 3 doses)Experimental Treatment1 Intervention

Up to 18 participants will be enrolled (Up to 6 participants, for 5 completers per cohort). Each successive cohort of participants will receive STM-01 at the following doses: 50.0 x 106 neonatal mesenchymal stem cells (nMSCs), 100.0 x 106 nMSCs, and 200.0 x 106 nMSCs.

0 / 2Eligibility criteria met