BioCardia’s CardiAMP HF II Phase 3 Trial: First Patient Enrolled at University of Wisconsin

Date: Nov 1, 2025

Summary BioCardia announced that the University of Wisconsin School of Medicine and Public Health enrolled its first patient in the Phase 3 CardiAMP HF II trial. This trial is testing CardiAMP, an autologous (patient’s own) bone marrow cell therapy, in people with ischemic heart failure with reduced ejection fraction (HFrEF) who still have signs of heart stress despite optimized medical care.

Why this matters Heart failure related to reduced ejection fraction is common as people age and contributes to disability and shortened lifespan. New regenerative approaches like CardiAMP aim to repair damaged heart tissue, improve blood flow at the small-vessel level, and slow or reverse deterioration. Positive results could expand options that preserve heart function and quality of life—outcomes that are directly relevant to longevity and healthy aging.

Trial design and key details

• Trial name: CardiAMP HF II (Phase 3)
• Size and design: 250-patient, randomized, multicenter, placebo-controlled study
• Purpose: Test safety and effectiveness of a one-time CardiAMP autologous cell therapy procedure
• Primary outcomes: A three-tier composite endpoint that includes all-cause mortality, non-fatal major adverse cardiac events, and measures of quality of life (this mirrors endpoints from the earlier CardiAMP study)
• Notable upgrades versus prior study:
• Cell population analysis at screening to define individualized treatment doses (this helps ensure each patient receives an appropriate number of therapeutic cells)
• Improvements to the Helix delivery system, using the FDA-cleared Morph DNA steerable platform for more precise placement of therapy in the heart
• Regulatory/support status:
• CardiAMP has FDA Breakthrough Device designation
• Development supported by the Maryland Stem Cell Research Fund
• CMS (Centers for Medicare & Medicaid Services) reimbursement is in place for the program

What CardiAMP therapy is and how it works (plain language)

• Source of cells: The therapy uses a patient’s own bone marrow cells (autologous). Bone marrow contains various stem and progenitor cells that can support tissue repair.
• Delivery method: Cells are delivered directly into the heart muscle in a minimally invasive, catheter-based procedure—no open-heart surgery. The Helix/Morph platform helps doctors steer the catheter to specific areas of damaged heart tissue.
• Intended effect: The cells aim to increase tiny blood vessels (capillary density) and reduce scarring (fibrosis) in the heart. By improving the microcirculation and reducing scar tissue, the therapy targets microvascular dysfunction—a common problem in ischemic heart disease that limits oxygen delivery and healing.
• Expected clinical benefit: Earlier studies suggested improvements for patients who still had elevated NT-proBNP (a blood marker of heart stress), including better survival/clinical event profiles and quality of life.

Key clinical data referenced

• Prior CardiAMP study: Showed statistically significant improvements in the three-tier composite endpoint among patients with elevated NT-proBNP who received CardiAMP versus control. (NT-proBNP is a lab test that rises when the heart is under stress and is commonly used to assess heart failure severity.)

Plain-language explanation of important terms

• HFrEF (heart failure with reduced ejection fraction): A form of heart failure where the heart pumps less blood with each beat. Common in ischemic heart disease and older adults.
• NT-proBNP: A blood biomarker that increases when the heart is stressed or failing. Higher values often mean more severe heart failure.
• Autologous vs allogeneic: Autologous = cells come from the same person who will receive them (low risk of immune rejection). Allogeneic = cells come from a donor (may be off-the-shelf but can carry immune compatibility considerations).
• FDA Breakthrough designation: A program to speed development and review of devices that may offer substantial improvement over existing therapies for serious conditions.

Quotes

• Dr. Amish Raval, M.D., Professor of Medicine at UW School of Medicine and Public Health and CardiAMP HF II Trial National Co-Principal Investigator:

“CardiAMP cell therapy has shown evidence of benefit for ischemic heart failure patients with elevated markers of heart stress, despite being on optimized medical therapy. We look forward to offering patients the opportunity to participate in this important study and potentially contributing to the evidence that may enable this therapy to be more broadly available.”

• Peter Altman, PhD, CEO of BioCardia:

“We are pleased that the UW School of Medicine and Public Health has completed their first enrollment in our ongoing Phase 3 CardiAMP HF II clinical trial. The leadership of this prestigious cardiology center strengthens our trial. We share the vision of providing specialized medicine that translates into personalized care for improved patient outcomes.”

Context for stem cell banking, regenerative medicine, and healthy aging

• Why cell source matters: Because CardiAMP uses a patient’s own bone marrow cells, having access to viable autologous cells is important. For some regenerative therapies, people may benefit from reserving their own cells earlier in life (for example, cord blood or personal cell banking) to maximize cell quality decades later. Aging reduces some regenerative cell populations; banking cells when they are younger can preserve higher-quality material for future therapies.
• Autologous preservation strategies: Stem cell banking typically refers to storing cord blood or other tissue-derived stem cells at birth or storing harvested autologous cells for future personalized treatment. For adult-onset diseases like ischemic heart failure, autologous bone marrow or adipose-derived cells collected and stored earlier could be useful if autologous therapy becomes standard.
• Allogeneic alternatives: BioCardia is also developing allogeneic products (CardiALLO) that use donor cells and could be available off-the-shelf. Each approach has trade-offs: autologous reduces immune risk; allogeneic may be immediately available but may require matching or immune management.
• Practical implications for patients and families:
• If you are interested in maximizing future regenerative options, learn about cord blood and stem cell banking early—these are most relevant at birth but there are also adult banking options.
• For people already diagnosed with heart disease, clinical trials like CardiAMP may offer access to cutting-edge treatments under medical oversight; discuss eligibility with your care team.
• Keep in mind that Phase 3 trials are designed to confirm earlier findings; positive Phase 3 results could lead to broader availability, while negative results could halt a program. Reimbursement support (e.g., CMS) and Breakthrough designation can accelerate access if efficacy and safety are confirmed.

What to watch next

• Enrollment progress and final results from the 250-patient Phase 3 trial—these will determine whether CardiAMP can become a widely available treatment.
• Publication of detailed trial results, including safety data, magnitude of benefit on the composite endpoint, and subgroup analyses by NT-proBNP and other markers.
• Development milestones for delivery systems (Helix/Morph) and for BioCardia’s allogeneic program (CardiALLO).
• Policy and coverage decisions that affect access and cost for patients (CMS and other payers).

About the company (brief) BioCardia (headquartered in Sunnyvale, California) develops cellular and cell-derived therapies for cardiovascular and pulmonary diseases. Their platforms include CardiAMP (autologous) and CardiALLO (allogeneic), and delivery technologies Helix and Morph to target therapies precisely in the heart.

Research support and funding

• Maryland Stem Cell Research Fund supported parts of the program.
• Centers for Medicare and Medicaid Services (CMS) has provided reimbursement support for the CardiAMP program.