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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment called STM-01 to determine its safety and tolerability for individuals with a specific type of heart failure known as HFpEF. HFpEF occurs when the heart pumps normally, but stiff heart muscles make it difficult for the heart to fill with blood. The trial involves different groups receiving varying doses to identify the optimal level. Suitable candidates for this trial have had a stable heart failure diagnosis for at least six months and are already on standard heart failure medications. As a Phase 1 trial, this research aims to understand how STM-01 works in people, offering participants the opportunity to be among the first to receive this new treatment.

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.

Is there any evidence suggesting that STM-01 is likely to be safe for humans?

Research has shown that STM-01 is a new treatment under testing for heart failure. The FDA has granted it Fast Track status, indicating its potential. However, STM-01 remains in the early testing stages, with researchers primarily assessing its safety and tolerability.

Detailed safety information from earlier studies is not yet available. Researchers are beginning human trials to evaluate STM-01's safety and potential side effects. Early-phase trials are crucial for determining safety before broader testing. Currently, specific information on side effects or tolerability is unavailable, but these early tests aim to uncover such details.

It is important to note that early-phase status means the treatment is still under careful study and has not been proven safe or effective. Participants will receive close monitoring to gather essential safety information. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for heart failure?

Researchers are excited about STM-01 for heart failure because it uses a cutting-edge approach involving mesenchymal stem cells (nMSCs). Unlike traditional treatments, which often focus on managing symptoms with medications like beta-blockers, ACE inhibitors, or diuretics, STM-01 aims to repair and regenerate damaged heart tissue. This regenerative approach has the potential to improve heart function at a cellular level, offering a promising new avenue for treating heart failure beyond symptom management.

What evidence suggests that STM-01 might be an effective treatment for heart failure?

Research has shown that STM-01 may be a promising treatment for heart failure with preserved ejection fraction (HFpEF). STM-01 derives from special cells that can help repair heart tissue. The FDA has granted it a Fast Track designation, highlighting its potential importance. Although limited data from human studies exist due to its novelty, the treatment aims to improve heart function by repairing damaged heart cells. Early results suggest it is safe, and there is hope it could help improve symptoms for people with HFpEF. ^{1 2 5 6 7}

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06560762

NCT06560762 | Study in Participants With Heart Failure ... ... STM-01 in Participants With Heart Failure With Preserved Ejection Fraction (HFpEF). Conditions. Heart Failure With Preserved Ejection Fraction (HFpEF). Heart ...

2. withpower.com withpower.com/trial/phase-1-heart-failure-8-2024-beb1b

STM01 for Heart Failure · Recruiting Participants for Phase ... This Phase 1 medical study run by Secretome Therapeutics is evaluating whether STM-01 will have tolerable side effects & efficacy for patients with Heart ...

3. thecardiologyadvisor.com thecardiologyadvisor.com/news/neonatal-cardiac-progenitor-cell-therapy-fast-tracked-for-hfpef/

Neonatal Cardiac Progenitor Cell Therapy Fast Tracked for ... The FDA has granted Fast Track designation to STM-01 for the treatment of heart failure with preserved ejection fraction.

4. biospace.com biospace.com/press-releases/secretome-therapeutics-announces-first-patient-dosed-in-groundbreaking-phase-1-study-of-stm-01-in-heart-failure-with-preserved-ejection-fraction

Secretome Therapeutics Announces First Patient Dosed in ... Secretome Therapeutics Announces First Patient Dosed in Groundbreaking Phase 1 Study of STM-01 in Heart Failure with Preserved Ejection Fraction.

5. synapse.patsnap.com synapse.patsnap.com/article/secretome-therapeutics-begins-phase-1-trial-of-stm-01-for-heart-failure-with-first-patient-dosed

Secretome Therapeutics Begins Phase 1 Trial of STM-01 ... This trial is focused on evaluating STM-01, a novel therapy derived from neonatal cardiac progenitor cells (nCPC), for treating heart failure ...

6. biospace.com biospace.com/press-releases/secretome-therapeutics-initiates-phase-1-clinical-trial-of-stm-01-in-patients-with-dilated-cardiomyopathy

Secretome Therapeutics Initiates Phase 1 Clinical Trial of ... Our lead product, STM-01, is a first-in-class cellular therapy designed to modulate inflammatory and fibrotic pathways and support myocardial ...

7. pharmacytimes.com pharmacytimes.com/view/fda-grants-fast-track-designation-to-stm-01-neonatal-cardiac-cell-therapy-for-treatment-of-hfpef

FDA Grants Fast Track Designation to STM-01, Neonatal ... The innovative neonatal cardiac progenitor cell therapy is designed to repair heart tissue in patients with heart failure with preserved ...