Cell-directed Immunomodulation to Help with LVAD Surgery in Chronic Heart Failure
Official title: Cell Directed Immunomodulation Therapy as a Bridge to Left Ventricular Device Implantation in Chronic Heart Failure Patients
Funded at Innovative Biotherapies, INC. · NIH-11361118 · Data updated 2026-11-12
A patient-friendly approach tests an immunomodulation device to improve heart and kidney function in people with advanced heart failure who are awaiting LVAD implantation but currently ineligible.
Quick facts
| Grant type | Sbir 2 grant |
|---|---|
| Study type | NIH-funded research |
| Funding institution | Innovative Biotherapies, INC. NIH-funded |
| Lab location | 1 site (Ann Arbor, United States) |
| Project start | June 1, 2024 |
| Project end | May 31, 2027 |
| Funding year | 2026 |
| Award (this year) | $797,411 |
| NIH project number | 5R44HL170779-03 |
| Project ID | NIH-11361118 on NIH RePORTER |
Who could benefit from this research
✓Could help
Adults with chronic heart failure who are decompensated and deemed ineligible for LVAD implantation but are suitable for an immunomodulatory bridging therapy.
✕Less likely to help
Patients for whom LVAD implantation remains unsuitable or who cannot tolerate extracorporeal therapy may not benefit.
What this research studies
This project explores using an extracorporeal immunomodulatory device, the Selective Cytopheretic Device (SCD), to reduce the harmful inflammatory effects of chronic heart failure and support patients as they wait for LVAD surgery. It will assess safety and potential benefits in improving heart or kidney function during this bridging period. The study involves patients who are eligible for the device pathway but cannot yet undergo LVAD implantation, with the goal of enabling a life-saving procedure. If successful, the work could lead to a humanitarian device exemption to accelerate access for this high-need group.
Why it matters
Potential benefit: If successful, this approach could improve organ function and enable life-saving LVAD implantation for patients who are currently ineligible.
How similar studies have gone: Prior immunomodulation approaches have shown potential in modulating inflammation, but this exact device-based bridge strategy is investigational with limited prior human data.
Where this research is happening
-
Innovative Biotherapies, INC.
Ann Arbor, United States Active
Researchers
- Principal investigator: Johnston, Kimberly Anne — Innovative Biotherapies, INC.
- Study coordinator: Johnston, Kimberly Anne
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About this research
- This is an active NIH-funded research project — typically early-stage science, not a clinical trial accepting patient enrollment.
- Some NIH-funded labs run parallel clinical studies or seek volunteers for related work. To check, contact the principal investigator or institution listed above.
- For full project details, budget, and progress reports, visit the official NIH RePORTER page.