๐Ÿ›๏ธ Verified NIH Record โ€ข Updated 2026-06-25

HiCM-188 Cell Therapy in Adults With Advanced Heart Failure Undergoing Heart Bypass Surgery (NCT07646210)

A Phase I/IIa, Open-Label, Dose Escalation Study to Evaluate the Safety and Tolerability of HiCM-188, an Allogeneic iPSC-derived Cardiomyocyte Therapy, in Adult Patients With Advanced Heart Failure

๐ŸŸก Not Yet Recruiting Phase1 / Phase2 ๐Ÿ’Š Investigational Drug / Biologic Sponsor: HELP Therapeutics Co., Ltd.

๐Ÿฉบ Plain-English Summary (8th-Grade Level)

This clinical study will evaluate the safety and tolerability of HiCM-188, an investigational allogeneic induced pluripotent stem cell (iPSC)-derived cardiomyocyte therapy, in adults with advanced heart failure who are undergoing coronary artery bypass grafting (CABG) surgery. Participants who meet the study eligibility criteria will receive a single dose intramyocardial injection of HiCM-188 during CABG surgery. The study will evaluate two dose levels of HiCM-188 using an open-label dose-escalation design. Participants will be followed for up to 12 months after treatment to monitor safety and preliminary signs of clinical effect.

Who can join: Review the eligibility criteria below.

Location: The Texas Heart Institute at Baylor College of Medicine โ€” Houston, Texas

Age range: 18 Years to 75 Years

๐Ÿงช Interventions in This Study

๐Ÿ“‹ "Do I Qualify?" โ€” 1-Minute Self Screener

Instant Checklist

Full eligibility criteria are available on the official NIH protocol. View the criteria โ†—

๐Ÿ“ All Participating Trial Locations (1 Sites)

  • The Texas Heart Institute at Baylor College of Medicine โ€” Houston, Texas

๐Ÿ“ž Contact the Study Coordinator

Phone: (650) 504-5586

Email: Alex.zhang@helptx.com.cn

Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.

๐Ÿ’ฐ Cost, Insurance & Patient Rights

  • 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
  • Routine Patient Care: Under federal law (ACA ยง 2709) and many state statutes, routine care costs are covered during participation.
  • Voluntary Participation: You may withdraw at any time without affecting your standard medical care.

๐Ÿ’ก How to Participate

  1. Check the checklist above to see if you may qualify.
  2. Contact the study coordinator using the phone/email above.
  3. Ask about the visit schedule, what is covered at no cost, and any travel support.
  4. Confirm with your own doctor before making a decision.
๐Ÿ›๏ธ View Official NIH Record โ†—