STM01 for Heart Failure

Recruiting at 1 trial location

Overseen By Malika Pasha

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Secretome Therapeutics

Must be taking: Heart failure therapy

Disqualifiers: Hypertrophic cardiomyopathy, Atrial fibrillation, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 6-8 weeks

12 Participants Needed

Trial Summary

What is the purpose of this trial?

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)

Do I need to stop my current medications for the trial?

The trial does not specify if you need to stop your current medications, but it requires that you have been on stable heart failure therapy for at least 30 days before screening. It's best to discuss your specific medications with the trial team.

What data supports the effectiveness of the drug STM-01 for heart failure?

Recent advances in heart failure treatment have shown that new drugs like angiotensin II receptor/neprilysin inhibitors and SGLT2 inhibitors can effectively reduce hospitalizations and improve survival. These findings suggest that STM-01, if similar, might also help improve outcomes for heart failure patients. ^{1 2 3 4 5}

How does the drug STM-01 for heart failure differ from other treatments?

STM-01 may offer a novel approach by potentially targeting specific molecular mechanisms involved in heart failure, such as improving heart muscle function or reducing stiffness, which current treatments like vasodilators and diuretics do not fully address. ^{6 7 8 9 10}

Eligibility Criteria

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.

Inclusion Criteria

Screening ejection fraction ≥50%

Documented prior objective evidence of heart failure

My organs and bone marrow are functioning well.

Exclusion Criteria

Other medical or psychiatric conditions that, in the opinion of the Investigator, would preclude obtaining voluntary consent/assent or would confound the objectives of the study

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

I have ongoing atrial fibrillation and haven't been on blood thinners for the last 4 weeks.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive STM-01 in a multiple ascending dose study to assess safety and tolerability

6-8 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• STM-01

Trial Overview 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.

Participant Groups

Group I: Dose arm (2 cohorts; 2 doses) Experimental Treatment 1 Intervention

Up to 12 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: 100.0 x 106 nMSCs, and 200.0 x 106 nMSCs.

Who Is Running the Clinical Trial?

Secretome Therapeutics

Lead Sponsor

Trials

1

Recruited

20+

Findings from Research

Heart failure (HF) is classified into four types based on left ventricular ejection fraction (LVEF), and despite advancements in treatment, it still has a poor prognosis with high rates of mortality and hospitalization.

Recent large-scale clinical trials have shown that new pharmacological agents, such as sacubitril/valsartan and SGLT2 inhibitors, are effective in improving outcomes for chronic heart failure, highlighting the need for continued development of innovative therapies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Recent advances in the pharmacological therapy of chronic heart failure: Evidence and guidelines. Tsutsui, H.[2022]

New therapeutic agents for heart failure can gain approval if they show improvements in survival rates, reduce hospitalizations, or safely enhance patients' functional capacity.

Recent regulatory practices emphasize the use of composite endpoints in clinical trials to efficiently assess the efficacy and safety of new heart failure treatments, including biologicals and cell therapies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical Trial Design, Endpoints, and Regulatory Requirements. Rosano, GMC.[2017]

Heart failure (HF) patients often face significant symptoms and limitations, and while many drugs aim to reduce hospitalizations and mortality, few focus on improving quality of life and physical function.

The paper highlights the potential for using patient-reported outcomes, which capture patients' perceptions of their health status, as important endpoints in the development of new HF medications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Endpoints in Heart Failure Drug Development: History and Future. Fiuzat, M., Lowy, N., Stockbridge, N., et al.[2021]

References

1. England pubmed.ncbi.nlm.nih.gov

Recent advances in the pharmacological therapy of chronic heart failure: Evidence and guidelines. [2022]

2. Germany pubmed.ncbi.nlm.nih.gov

Clinical Trial Design, Endpoints, and Regulatory Requirements. [2017]

3. United States pubmed.ncbi.nlm.nih.gov

Pharmacotherapy of systolic heart failure: emphasis on mortality outcomes. [2013]

4. England pubmed.ncbi.nlm.nih.gov

Treatment of severe heart failure: quantity or quality of life? A trial of enoximone. Enoximone Investigators. [2019]

5. United States pubmed.ncbi.nlm.nih.gov

Endpoints in Heart Failure Drug Development: History and Future. [2021]

6. England pubmed.ncbi.nlm.nih.gov

Advances in systolic heart failure. [2021]

7. United States pubmed.ncbi.nlm.nih.gov

Ischemic Cardiomyopathy and Heart Failure After Acute Myocardial Infarction. [2022]

8. Russia (Federation) pubmed.ncbi.nlm.nih.gov

[Myocardial remodeling in patients with chronic heart failure and implanted cardiac contractility modulators]. [2022]

9. England pubmed.ncbi.nlm.nih.gov

Targeting myocardial remodelling to develop novel therapies for heart failure: a position paper from the Working Group on Myocardial Function of the European Society of Cardiology. [2022]

10. United States pubmed.ncbi.nlm.nih.gov

Surgical ventricular restoration and other surgical approaches to heart failure. [2019]