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Dose arm (3 cohorts; 3 doses) 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
* Stable New York Heart Association (NYHA) Class II or III HF diagnosis, evident at least 6 months prior to enrolment as confirmed by medical history.
* Documented prior objective evidence of heart failure
Timeline
Screening 3 weeks
Treatment Varies
Follow Up dose 1 (day 0) till end of study (day 56)
Awards & highlights

Summary

A Phase 1, Open label, Multiple Ascending Dose Study to Assess Safety and Tolerability of STM-01 in Participants with Heart Failure with Preserved Ejection Fraction (HFpEF)

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

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~dose 1 (day 0) till end of study (day 56)
This trial's timeline: 3 weeks for screening, Varies for treatment, and dose 1 (day 0) till end of study (day 56) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Frequency, grade and relationship to STM-01 of unsolicited local and systemic AEs (any SAEs, MAAEs and AESIs ) during the 60-d follow-up period post IV infusion at D0 and D28 per the CTCAE v5.0 and clinical-safety laboratory parameters up to D 56.

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.

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Who is running the clinical trial?

Secretome TherapeuticsLead Sponsor
~12 spots leftby Sep 2025
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