Study in Participants With Heart Failure With Preserved Ejection Fraction (HFpEF)

Part of paid clinical trials in Chicago, Illinois.

Sponsor
Secretome Therapeutics
Study ID
NCT06560762
Phase
PHASE1
Status
Recruiting
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Conditions

  • Heart Failure With Preserved Ejection Fraction (HFpEF)

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • STM01 — DRUG
    Neonatal mesenchymal stem cells (nMSCs),

Study Details

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)

Key Dates

Start date
Mar 3, 2025
Status verified
Apr 2025
Primary completion
Dec 15, 2025
Completion
Dec 15, 2025

Study Design

Enrollment
12 participants (estimated)
Allocation
NA
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Other: Dose arm (2 cohorts; 2 doses)
    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.

Primary Outcome Measure

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. [ Time Frame: Dose 1 (Day 0) till end of study (Day 56) ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
Northwestern MedicineChicagoIllinois60611-5969-
UT Southwestern Medical CenterDallasTexas75390-

Find similar trials in Chicago, IL

By research site
Northwestern Medicine· Chicago, ILUT Southwestern Medical Center· Dallas, TX

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