Regen BioPharma, Inc. (OTC ID: RGBP and RGBPP) today provided further insight into its planned Phase 1 clinical trial of HemaXellerate, the company’s innovative stem cell-derived therapy, which has already received U.S. FDA clearance. While the initial focus is on treating aplastic anemia, a rare orphan indication, Regen BioPharma is evaluating expanded applications for this groundbreaking therapy in markets poised for significant growth.

Regen sees substantial potential in treating chemotherapy-induced bone marrow suppression, a market projected to be valued at well in excess of $1 billion annually. HemaXellerate is designed to stimulate bone marrow regeneration following injury caused by autoimmune conditions, chemotherapy, or radiation.

• HemaXellerate is comprised of cells extracted from the patient's own fat tissue and processed using a proprietary method to induce a biological response in the patient that heals damaged bone marrow and restores the body's ability to generate healthy blood cells.

“Aplastic anemia patients without access to bone marrow transplantation face limited options,” said Dr. David Koos, Chairman and CEO of Regen BioPharma. “With FDA clearance to begin clinical trials, HemaXellerate has the potential to redefine the treatment landscape—not just for aplastic anemia but for a wide range of hematological disorders. This is a pivotal moment for our company as we work to deliver life-changing therapies to patients worldwide.”

To ensure the trial’s success, Regen BioPharma has partnered with a clinical research organization (CRO) known for its expertise in conducting complex trials. Once initiated, the study is expected to reach completion within 12 to 14 months.

• Opportunity: Aplastic anemia is a rare disease with high unmet medical need, offering the potential for accelerated regulatory pathways and market exclusivity.
  
  
• Massive Market Potential: Expansion into chemotherapy-induced bone marrow suppression could unlock a multi-billion-dollar market.
  
  
• Strategic Execution: Collaboration with a leading CRO ensures focused execution and timeline adherence.