Cryo-Cell International Proudly Announces Two Ongoing COVID-19 Related Trials
Cryo-Cell International is conducting two pivotal clinical studies: MASC for COVID-19 related Acute Respiratory Distress Syndrome and MISTIC for children with Multisystem Inflammatory Syndrome associated with COVID-19. MASC has completed Phase 1 and is enrolling for Phase 2, while MISTIC is in Phase 1 enrollment. Both studies utilize human cord tissue derived mesenchymal stromal cells. The ongoing research underscores Cryo-Cell's commitment to advancing regenerative medicine and improving patient outcomes amid the ongoing pandemic.
- MASC study shows commitment towards addressing COVID-19 complications with ongoing Phase 2 enrollment.
- MISTIC study targets critical health issues in children, enhancing the company's research credibility.
- Reliance on clinical study outcomes introduces uncertainty for future revenue and market position.
- Potential delays in enrolling participants could impede progress in developing new therapies.
MIAMI, May 10, 2021 (GLOBE NEWSWIRE) -- Cryo-Cell’s Medical Director, Dr. Joanne Kurtzberg and her research team at The Marcus Center for Cellular Cures (MC3) at Duke University School of Medicine are currently conducting two major studies: MASC (Phase 1/2) & MISTIC (Phase 1) to treat, respectively, COVID-19 related Acute Respiratory Distress Syndrome (ARDS) and COVID-19 associated Multisystem Inflammatory Syndrome in Children (MIS -C).
David Portnoy, Chairman of the Board and Co-CEO of Cryo-Cell International, stated, “This unprecedented pandemic has undeniably changed the world as we know it. Through these two ongoing studies, which are subject to our licensing agreement with Duke University, Cryo-Cell hopes to be able to heal many patients that suffer from life threatening conditions relating to COVID-19.”
Clinical Study MASC:
MASC [NCT04399889] is a randomized, controlled study of safety and efficacy of cord tissue derived mesenchymal stromal cells (hCT-MSC) in COVID-19 related Acute Respiratory Distress Syndrome (ARDS). Phase 1 is already completed and Phase 2 is currently enrolling. MASC has a sample size of 50 patients; the first 10 patients participated in the Phase 1 (no randomization, no placebo) with the next 40 patients enrolling in the Phase 2 randomized, blinded, placebo-controlled trial 2:1:1 using cells manufactured at Duke University or at the University of Miami.
Clinical Study MISTIC:
MISTIC [NCT04549285] is a Phase 1 pilot study of the safety of infusions of allogeneic human cord tissue mesenchymal stromal cells in children with Multisystem Inflammatory Syndrome (MIS-C). Phase 1 is currently in the enrollment process.
Both studies use human cord tissue mesenchymal stromal cells (hCT-MSC) to treat the ARDS and MIS-C following COVID 19 infections.
About Cryo-Cell International, Inc.
Founded in 1989, Cryo-Cell International, Inc. is the world’s first private cord blood bank. More than 500,000 parents from 87 countries have entrusted Cryo-Cell International with their baby’s cord blood and cord tissue stem cells. In addition to its private bank, Cryo-Cell International has a public banking program in partnership with Duke University. Cryo-Cell’s public bank has provided cord blood for more than 600 transplantations and operates cord blood donation sites across the U.S. in prominent hospitals such as Cedars–Sinai Hospital in Los Angeles and Baptist Hospital in Miami. Cryo-Cell’s facility is FDA registered, cGMP-/cGTP-compliant and licensed in all states requiring licensure. Besides being AABB accredited as a cord blood facility, Cryo-Cell was also the first U.S. (for private use only) cord blood bank to receive FACT accreditation for adhering to the most stringent cord blood quality standards set by any internationally recognized, independent accrediting organization. Cryo-Cell owns the exclusive rights to PrepaCyte-CB, the industry’s most advanced cord blood processing technology.
Cryo-Cell’s mission has been to provide clients with state-of-the-art cord blood and cord tissue cryopreservation services, raise awareness of the opportunity for expectant parents to bank or donate their baby’s cord blood and support the advancement of regenerative medicine. In February 2021, Cryo-Cell entered into a license agreement with Duke University that transformed Cryo-Cell into an autonomous, vertically integrated cellular therapy company that will be able to treat patients.
Cryo-Cell is a publicly traded company, OTCQB:CCEL. For more information, please visit https://ir.cryo-cell.com.
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Forward-Looking Statements
Statements herein the terms “believes”, “intends”, “projects”, “anticipates”, “expects”, and similar expressions as used are intended to reflect “forward-looking statements” of the Company. The information contained herein is subject to various risks, uncertainties and other factors that could cause actual results to differ materially from the results anticipated in such forward-looking statements or paragraphs, many of which are outside the control of the Company. These uncertainties and other factors include the impact of the COVID-19 pandemic on our sales, operations and supply chain, the success of the Company’s global expansion initiatives and product diversification, the Company’s actual future ownership stake in future therapies emerging from its collaborative research partnerships, the success related to its IP portfolio, the Company’s future competitive position in stem cell innovation, future success of its core business and the competitive impact of public cord blood banking on the Company’s business, the success of the Company’s initiative to expand its core business units to include biopharmaceutical manufacturing and operating clinics, the uncertainty of profitability from its biopharmaceutical manufacturing and operating clinics, the Company’s ability to minimize future costs to the Company related to R&D initiatives and collaborations and the success of such initiatives and collaborations, the success and enforceability of the Company’s umbilical cord blood and cord tissue license agreements, together with the associated intellectual property and their ability to provide the Company with royalty fees, and those risks and uncertainties contained in risk factors described in documents the Company files from time to time with the Securities and Exchange Commission, including the most recent Annual Report on Form 10-K, Quarterly Reports on Form 10-Q and any Current Reports on Form 8-K filed by the Company. The Company disclaims any obligations to subsequently revise any forward-looking statements to reflect events or circumstances after the date of such statements.
For more information, please contact:
Corporate Communications / Investors Department
Diane Glanz, Rph, PharmD.
Telephone: +1 (813) 749-2195
Email: Investors@Cryo-Cell.com
FAQ
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