StemCyte, Inc.

BALDWIN PARK, Calif., Jan. 26, 2026 /PRNewswire/ -- StemCyte, Inc. today announced that the U.S. Food and Drug Administration (FDA) has cleared an Expanded Access (EA) program for RegeneCyte®, the company's FDA-licensed hematopoietic progenitor cell (HPC) therapy. This milestone enables eligible patients suffering from the debilitating effects of Post-Acute Sequelae of SARS-CoV-2 (Long COVID) to access the therapy while StemCyte continues its pivotal clinical research. This EA program follows compelling data from StemCyte's Phase IIa clinical trials. In those studies, 85% of Long COVID patients treated with RegeneCyte® experienced a statistically significant resolution of chronic fatigue, compared to just 20% in the placebo group. By authorizing Expanded Access, the FDA is providing a vital pathway for patients who are severely impacted by the syndrome but may not meet the specific enrollment criteria for ongoing Phase III multi-center trials. "The FDA's clearance of this program is a significant validation of the safety and therapeutic potential of RegeneCyte®, our HPC-cord blood product," said Dr. Tong-Young Lee, CEO of StemCyte. "With our RMAT (Regenerative Medicine Advanced Therapy) designation already in place, this program allows us to bridge the gap for patients in need as we continue advancing RegeneCyte® through the clinical development and regulatory pathway." The clearance of this program underscores the vital importance of newborn stem cell preservation. As regenerative medicine continues to evolve, RegeneCyte® serves as a primary example of how stored cord blood is being transformed into life-saving therapies for conditions previously thought untreatable, like Long COVID. RegeneCyte® is currently the only FDA-licensed cord blood product being evaluated in U.S. clinical trials for Long COVID. This EA program further solidifies StemCyte's transition from a premier cord blood bank to a leader in regenerative cell therapy. Physician Inquiry and Patient Eligibility The Expanded Access program is intended for patients with serious or life-threatening Long COVID symptoms who have exhausted standard treatment options. StemCyte will work directly with treating physicians to facilitate access under the FDA's compassionate use framework. About StemCyte StemCyte is a global regenerative medicine company dedicated to developing innovative cell therapies. With a foundation in FDA-licensed cord blood products and an extensive global cell bank, StemCyte is advancing a robust pipeline targeting Long COVID, stroke, and spinal cord injury. Forward-Looking Statements This release contains forward-looking statements regarding the efficacy of RegeneCyte® and the implementation of the Expanded Access program. Actual results may differ based on clinical outcomes and regulatory requirements. Media Contact Michael S. Teufenkjian Marketing Manager [email protected] SOURCE StemCyte 21% more press release views with Request a Demo

DUBLIN--( BUSINESS WIRE )--The "Cord Blood Banking Services - A Global Market Overview" report has been added to ResearchAndMarkets.com's offering. The global cord blood banking services market size was valued at US$32.2 billion in 2024 and is anticipated to reach US$47.9 billion by 2030, growing at a CAGR of 6.8% during the forecast period 2024-2030. This global report on Cord Blood Banking Services analyzes the global and regional market based on service, bank type, component, and application for the period 2021-2030 with projections from 2024 to 2030 in terms of value in US$. In addition to providing profiles of major companies operating in this space, the latest corporate and industrial developments have been covered to offer a clear panorama of how and where the market is progressing. The cord blood banking services market growth is propelled by the ease and safety of collecting stem cells from cord blood, growing awareness among parents regarding its potential medical benefits, and the increasing prevalence of autoimmune diseases, cancer, hematological disorders, and genetic issues. Progress in cord blood stem cell research, new therapies, and advancements in cord blood processing methods are driving market expansion. Technological innovations, growing awareness of stem cell treatments, and the emergence of personalized medicine are increasing the demand for private cord blood banking. The increasing occurrence of genetic disorders and advancements in biotechnology provide considerable opportunities for this market growth. Additionally, the expansion of healthcare facilities, government initiatives, and partnerships between cord blood banks and research organizations are supporting market expansion. Cord Blood Banking Services Regional Market Analysis In 2024, North America led the global cord blood banking services market, capturing 40.5% of the share, supported by a robust healthcare infrastructure, increased awareness, and rising healthcare spending in the U.S. and Canada. The region benefits from innovative technology, regulatory support, and a high birth rate, with prominent research institutions and cord blood banks playing a significant role in market growth. In contrast, the Asia Pacific region is expected to witness the fastest growth with a CAGR of 8.7% during the forecast period 2024-2030, driven by increasing awareness of stem cell therapies, enhanced healthcare policies, and a substantial birth rate, especially in China and India. The growing demand for stem cell therapies, rising disposable incomes, and supportive governmental initiatives are propelling market growth in APAC, establishing it as the fastest-growing area in cord blood banking services. Cord Blood Banking Market Analysis by Service Based on services, the processing segment leads the market in 2024, accounting for 35.8% of the market share. This dominance is driven by clinical trials, increased research on cord blood, and the growing prevalence of hematological disorders. The processing procedure involves separating blood cells and plasma and the cryopreservation of stem cells and white blood cells within 48 hours post-birth, a method widely practiced in public and private banks. Conversely, the storage segment is projected to record the fastest CAGR of 8.3% from 2024 to 2030, driven by increasing parental awareness and demand for cord blood storage for future use. Storage provides an economical option for long-term preservation, making it a significant factor in the market's expansion. Cord Blood Banking Services Market Analysis by Bank Type Based on cord blood bank type, the private bank is the largest segment, with an estimated 54.7% share in 2024. Private banks preserve cord blood solely for donors and their families, providing tailored services, guaranteed availability of blood, and the possibility of future medical applications, which propels their expansion. Factors such as a growing demand for personalized medicine, increasing awareness of stem cell therapies, and concerns about future health requirements further enhance the private sector's leading position. Meanwhile, the public banks are anticipated to register the fastest growth with a CAGR of 7.7% from 2024 to 2030, driven by the ethical incentive of donating cord blood for public benefit, enabling access to stem cell transplants and research. Public banks advocate for community health, advance medical research, and widen access to life-saving treatments, supporting their growth. Cord Blood Banking Services Market Analysis by Component Based on components, the cord blood segment leads the market, with an estimated 73.7% share in 2024, propelled by the growing use of stem cell therapies for disorders related to hematology, immunity, and cancer. The expansion of this segment is supported by advancements in stem cell research, heightened public awareness, and a rising number of parents opting to bank cord blood for potential future health needs. On the other hand, the cord tissue segment is expected to witness the fastest growth rate at a CAGR of 7.5% during the forecast period, driven by its abundant supply of mesenchymal stem cells (MSCs), which are valued for their regenerative abilities, ease of access, immune system modulation benefits, and lower risks of rejection. Technological advancements and ongoing studies in cord tissue processing and storage further boost its market appeal, leading to a surge in demand for cord tissue banking. Cord Blood Banking Services Market Analysis by Application Based on application, cancer, and blood disorders are projected to account for more than 60% of the market share in 2024 due to the essential function of cord blood in hematopoietic stem cell transplants for the treatment of conditions such as leukemia, lymphoma, sickle cell anemia, and thalassemia. Among these, the cancer segment is expected to experience the fastest growth with a CAGR of 7.5% during the analysis period 2024-2030. This growth is fueled by the increasing prevalence of cancer, a rise in approvals for cord blood-based therapies, advancements in research, and a broader adoption of these therapies in oncology practices. Additionally, government funding and awareness programs bolster the market by enhancing access to stem cell transplants for cancer treatment, thereby improving outcomes for patients and their families. Key Metrics Historical Period: 2021-2023 Base Year: 2024 Forecast Period: 2024-2030 Units: Value market in US$ Companies Mentioned: 28+ Key Attributes: Report Attribute Details No. of Pages 295 Forecast Period 2024 - 2030 Estimated Market Value (USD) in 2024 $32.2 Billion Forecasted Market Value (USD) by 2030 $47.9 Billion Compound Annual Growth Rate 6.8% Regions Covered Global Key Topics Covered: 1. Introduction Product Outline Cord Blood Banking Services Defined Cord Blood Banking Services Collection & Transportation Processing Analysis Storage Cord Blood Banking Service Bank Types Private Public Cord Blood Banking Service Components Cord Blood Cord Tissue Cord Blood Banking Service Applications Cancer Blood Disorders Immune Deficiencies Metabolic Disorders Other Applications (Including Osteopetrosis, Neurological Disorders, Cardiovascular Disorders, and others) 2. Key Market Trends 3. Key Global Players Alphacord LLC Americord Registry LLC Banco de Cordon Umbilical (BCU) BIOCORD AG Carolinas Cord Blood Bank (CCBB) Cells4Life Group LLP CooperSurgical Inc. CordBank NZ Cordlife Group Limited Cryo Stemcell Karnataka Pvt Ltd Cryo-Cell International, Inc. Cryosite Limited Cryoviva Biotech Pvt. Ltd. CSG-BIO Famicord Group Future Health Biobank INNOVIA BioBank Jeevan Stem Cell Foundation Lifebank USA LifeCell International Pvt. Ltd. Maze Cord Blood Laboratories NeoStem, Inc New England Cord Blood Bank, Inc. Singapore Cord Blood Bank (SCBB) StemCyte, Inc. ViaCord (a part of Revvity) Virgin Health Bank VITA 34 AG 4. Key Business & Type Trends 5. Global Market Overview Global Cord Blood Banking Services Market Overview by Service Cord Blood Banking Services Market Overview by Global Region Collection & Transportation Processing Analysis Storage Global Cord Blood Banking Services Market Overview by Bank Type Cord Blood Banking Services Bank Type Market Overview by Global Region Private Public Global Cord Blood Banking Services Market Overview by Component Cord Blood Banking Services Component Market Overview by Global Region Cord Blood Cord Tissue Global Cord Blood Banking Services Market Overview by Application Cord Blood Banking Services Application Market Overview by Global Region Orthopedics Cardiology Urology Dental Neurology Ophthalmology Other Applications For more information about this report visit https://www.researchandmarkets.com/r/guyfmk About ResearchAndMarkets.com ResearchAndMarkets.com is the world's leading source for international market research reports and market data. 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BALDWIN PARK, Calif., Dec. 19, 2024 /PRNewswire/ -- StemCyte announced a significant breakthrough in its Phase IIa clinical trial of HPC, Cord Blood (HPC, CB) for treating Post-COVID Syndrome (Long COVID). This trial results demonstrated that cord blood significantly improved fatigue symptoms, with 85% of subjects in the cord blood group reporting complete relief from fatigue after treatment, compared to just 20% in the placebo group. The clinical efficacy showed a statistically significant difference (p<0.01), meeting the trial's efficacy endpoints. The overall safety and tolerance of the drug were also favorable. Continue Reading Clinical Trial Background Regenecyte™: FDA-licensed HPC, Cord Blood set for next-stage clinical trials under RMAT designation. Post this In 2020, StemCyte received approval from the U.S. FDA to initiate a randomized, controlled, double-arm Phase IIa clinical trial evaluating the safety and efficacy of human umbilical cord blood in treating Post-COVID syndrome (NCT# NCT05682560). The trial was conducted in the United States and successfully recruited 30 participants. Of these, 20 participants received HPC, CB treatment, while 10 received a placebo. On December 13, 2024, the statistical data from the Phase IIa clinical trial were officially obtained. Primary Safety Endpoint Achieved The primary safety endpoint, based on the incidence of treatment-emergent adverse events (TEAEs), was successfully met. In the HPC, CB treatment group, 2 out of 20 participants experienced TEAEs, with no severe adverse events (SAEs), and all adverse events were resolved within 1 hour. The TEAE incidence rate for the HPC, CB group was 10%. In the placebo group, 2 out of 10 participants experienced TEAEs, with no SAEs, resulting in a TEAE incidence rate of 20%. Both TEAEs were unrelated to the treatment and were resolved with appropriate management. These results demonstrate that HPC, CB has good safety and tolerance in Post-COVID patients, with no severe adverse events that could impact the treatment. Secondary Efficacy Endpoint Achieved (P<0.01) The Chalder Fatigue Questionnaire (CFQ-11) was used to assess the severity of fatigue symptoms. The results revealed significant improvements in fatigue symptoms, fatigue severity, and physical fatigue for Post-COVID patients treated with cord blood. The secondary efficacy endpoints were successfully met, with the following results: Fatigue Determination: All 30 participants had fatigue symptoms (CFQ-11 score ≥4) prior to treatment. After HPC, CB treatment, significant improvements in fatigue symptoms were observed at week 6 (p<0.001), week 12 (p<0.001), week 18 (p=0.002), and week 26 (p=0.007), with statistical significance compared to the placebo group. At the end of the trial (week 26), 85% of cord blood-treated patients had their fatigue symptoms resolved (17 out of 20 participants had a score <4), compared to only 20% in the placebo group (2 out of 10 participants had a score <4). Fatigue Severity: Significant reductions in fatigue severity were observed at week 6 (p<0.001), week 12 (p<0.001), week 18 (p<0.001), and week 26 (p=0.004) in the HPC, CB group, compared to the placebo group. Physical Fatigue Severity: HPC, CB treatment significantly improved physical fatigue severity at week 6 (p<0.001), week 12 (p<0.001), week 18 (p<0.001), and week 26 (p=0.005), with statistical significance compared to the placebo group. Psychological Fatigue Severity: No significant improvement in psychological fatigue was observed between the HPC, CB and placebo groups (p>0.05), indicating that the treatment did not significantly impact psychological fatigue. Exploratory Assessment Endpoints PGI-S Scale: The PGI-S scale, used to assess changes in fatigue symptoms, showed significant improvements in the HPC, CB group at week 12 (p=0.001), week 18 (p=0.004), and week 26 (p=0.007), with statistical significance compared to the placebo group. These results were consistent with the CFQ-11 scale findings. Montreal Cognitive Assessment (MoCA): The MoCA scale, used to assess cognitive function, showed that the average MoCA score for the 30 participants was 24 before treatment. After cord blood treatment, the average score increased to 26 at week 12 and week 26. However, no significant statistical change was observed compared to the placebo group (p>0.05). FDA RMAT Designation – A Key Advantage StemCyte's newly licensed HPC, Cord Blood product REGENECYTE™ has been granted the FDA's Regenerative Medicine Advanced Therapy (RMAT) designation, a recognition given to therapies with the potential to offer significant benefits over existing treatments for serious or life-threatening conditions. This designation allows StemCyte to work closely with the FDA, expediting the development process and facilitating priority review and potential accelerated approval pathways for REGENECYTE™. As the first product globally to receive FDA approval for Phase II clinical trials using allogeneic umbilical cord blood stem cells for treating Post-COVID syndrome, REGENECYTE™ holds a unique position in the development of therapies for this condition. Phase IIa Clinical Trial Success and Next Steps The HPC, Cord Blood Phase IIa clinical trial results have demonstrated strong safety and efficacy, particularly in improving fatigue symptoms in Post-COVID patients. Given the statistically significant improvements in fatigue severity (p<0.01), the treatment holds promise as a solution for addressing unmet medical needs in Post-COVID care. Building on these positive results, StemCyte is preparing to accelerate the development of REGENECYTE™ and is in rolling discussions with the FDA to move forward with the next phase of clinical trials. Expansion of RegeneCyte's Application In addition to its potential in treating Post-COVID syndrome, StemCyte is exploring broader applications for REGENECYTE™. The Phase II trial's positive impact on reducing patient frailty lays the foundation for expanding its use into chronic fatigue syndrome and the global anti-aging market. As the U.S. remains the largest pharmaceutical market worldwide, the demand for effective treatments for chronic conditions like Post-COVID and fatigue is anticipated to rise. StemCyte aims to meet this growing demand by accelerating REGENECYTE's commercialization and exploring international collaborations and licensing opportunities to expand its global footprint. About StemCyte StemCyte is a leader in regenerative medicine, dedicated to developing and delivering innovative therapies using cord blood. With a commitment to improving patient outcomes worldwide, StemCyte is at the forefront of exploring the potential of cord blood-derived therapies to address a variety of medical conditions. Through continuous research and clinical advancements, StemCyte aims to provide groundbreaking solutions that enhance the quality of life for patients around the globe. Media Contact: [email protected] SOURCE StemCyte WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED