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OLDSMAR, Fla., July 07, 2017 (GLOBE NEWSWIRE) -- Cryo-Cell International, Inc. (OTCQB:CCEL) (the “Company”), the world’s first private cord blood bank to separate and store stem cells in 1992, announced results for the fiscal second quarter ended May 31, 2017.  Consolidated revenues for the second quarter of fiscal 2017 were $6,200,000 compared to $5,800,000 for the second quarter of fiscal 2016.  The revenues for the 2017 quarter consisted of $5,800,000 in processing and storage fee revenue, $329,000 in licensee and royalty income and $62,000 in product revenue compared to $5,300,000 in processing and storage fee revenue, $357,000 in licensee and royalty income and $66,000 in product revenue for the 2016 quarter. The Company reported net income for the three months ended May 31, 2017 of $497,000, or $0.07 per basic share and $0.06 per diluted share, compared to net income of 637,000, or $0.07 per basic and diluted share for the three months ended May 31, 2016.  For the three months ended May 31, 2017, there was a 9% increase in processing and storage revenues, partially offset by an 11% increase in cost of sales and a less than 1% increase in selling, general and administrative expenses.  Net income for the 2016 period resulted in part from a gain on extinguishment of debt in the amount of $300,593.  The gain was a result of the Company’s payment in April 2016 of $778,000 representing payment in full to CytoMedical Design Group LLC (“CMDG”) pursuant to the terms of the original Asset Purchase Agreement and Promissory Note, as well as pursuant to the terms of the Loan/Promissory Note Sale Agreement and Mutual Release executed by the Company and CMDG on April 22, 2016. At May 31, 2017, the Company had cash and cash equivalents of $4,700,000.  The Company’s cash increased $1,200,000 during the first six months of fiscal 2017.  Cash provided by operations was $2,400,000 and cash provided by the sale of marketable securities was approximately $173,000 which were offset by $404,000 used for stock repurchases and $1,000,000 used to repay the note payable.  On May 20, 2016, the Company entered into a Subordination Agreement with Texas Capital Bank and CrowdOut Capital LLC (“CrowdOut”) for a subordinated loan of the principal amount of $650,000, which amount CrowdOut advanced to the Company on May 20, 2016.  In June 2017, the Company repaid the $650,000 principal amount of the subordinated loan. Founded in 1989, Cryo-Cell International, Inc. is the world's first private cord blood bank.  More than 500,000 parents from 87 countries trust Cryo-Cell to preserve their family members' stem cells.  Cryo-Cell's mission is to provide clients with state-of-the-art stem cell cryopreservation services and support the advancement of regenerative medicine. Cryo-Cell operates in a facility that is FDA registered, cGMP-/cGTP-compliant and is licensed in all states requiring licensure. Besides being AABB accredited as a cord blood facility, Cryo-Cell is 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. In addition, Cryo-Cell is ISO 9001:2008 certified by BSI, an internationally recognized, quality assessment organization. Cryo-Cell is a publicly traded company, OTCQB:CCEL. For more information, please visit www.cryo-cell.com. Statements wherein 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 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 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 menstrual stem cell technology license agreements and umbilical cord blood license agreements and their ability to provide the Company with royalty fees, the ability of the reproductive tissue storage to generate new revenues for the Company 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.


Sanberg P.R.,University of South Florida | Eve D.J.,University of South Florida | Willing A.E.,University of South Florida | Garbuzova-Davis S.,University of South Florida | And 5 more authors.
Cell Transplantation | Year: 2011

Stem cell transplantation is a potentially important means of treatment for a number of disorders. Two different stem cell populations of interest are mononuclear umbilical cord blood cells and menstrual blood-derived stem cells. These cells are relatively easy to obtain, appear to be pluripotent, and are immunologically immature. These cells, particularly umbilical cord blood cells, have been studied as either single or multiple injections in a number of animal models of neurodegenerative disorders with some degree of success, including stroke, Alzheimer's disease, amyotrophic lateral sclerosis, and Sanfilippo syndrome type B. Evidence of anti-inflammatory effects and secretion of specific cytokines and growth factors that promote cell survival, rather than cell replacement, have been detected in both transplanted cells. Copyright © 2011 Cognizant Comm. Corp. All rights reserved.


Borlongan C.V.,University of South Florida | Kaneko Y.,University of South Florida | Maki M.,Georgia Regents University | Yu S.-J.,University of South Florida | And 5 more authors.
Stem Cells and Development | Year: 2010

Cell therapy remains an experimental treatment for neurological disorders. A major obstacle in pursuing the clinical application of this therapy is finding the optimal cell type that will allow benefit to a large patient population with minimal complications. A cell type that is a complete match of the transplant recipient appears as an optimal scenario. Here, we report that menstrual blood may be an important source of autologous stem cells. Immunocytochemical assays of cultured menstrual blood reveal that they express embryonic-like stem cell phenotypic markers (Oct4, SSEA, Nanog), and when grown in appropriate conditioned media, express neuronal phenotypic markers (Nestin, MAP2). In order to test the therapeutic potential of these cells, we used the in vitro stroke model of oxygen glucose deprivation (OGD) and found that OGD-exposed primary rat neurons that were co-cultured with menstrual blood-derived stem cells or exposed to the media collected from cultured menstrual blood exhibited significantly reduced cell death. Trophic factors, such as VEGF, BDNF, and NT-3, were up-regulated in the media of OGD-exposed cultured menstrual blood-derived stem cells. Transplantation of menstrual blood-derived stem cells, either intracerebrally or intravenously and without immunosuppression, after experimentally induced ischemic stroke in adult rats also significantly reduced behavioral and histological impairments compared to vehicle-infused rats. Menstrual blood-derived cells exemplify a source of "individually tailored" donor cells that completely match the transplant recipient, at least in women. The present neurostructural and behavioral benefits afforded by transplanted menstrual blood-derived cells support their use as a stem cell source for cell therapy in stroke. © Mary Ann Liebert, Inc. 2010.


PubMed | University of South Florida, Cryo Cell International Inc., University of Sao Paulo and Saneron Ccel Therapeutics, Inc.
Type: Journal Article | Journal: Interventional medicine & applied science | Year: 2014

Cerebrovascular diseases are a major cause of death and long-term disability in developed countries. Tissue plasmin activator (tPA) is the only approved therapy for ischemic stroke, strongly limited by the short therapeutic window and hemorrhagic complications, therefore excluding most patients from its benefits. The rescue of the penumbra area of the ischemic infarct is decisive for functional recovery after stroke. Inflammation is a key feature in the penumbra area and it plays a dual role, improving injury in early phases but impairing neural survival at later stages. Stem cells can be opportunely used to modulate inflammation, abrogate cell death and, therefore, preserve neural function. We here discuss the possible role of stem cells derived from menstrual blood as restorative treatment for stroke. We highlight the availability, proliferative capacity, pluripotentiality and angiogenic features of these cells and explore their present and future experimental and clinical applications.


News Article | February 28, 2017
Site: globenewswire.com

OLDSMAR, Fla., Feb. 28, 2017 (GLOBE NEWSWIRE) -- Cryo-Cell International, Inc. (OTCQB:CCEL) (the “Company”), the world’s first private cord blood bank to separate and store stem cells in 1992, announced results for its fiscal year 2016.   Consolidated revenues for fiscal 2016 were approximately $23.1 million compared to approximately $21.1 million for fiscal 2015.  The revenues for fiscal 2016 consisted of approximately $21.8 million in processing and storage fee revenue, $1.0 million in licensee income, and $350,000 in product revenue compared to approximately $19.6 million in processing and storage fee revenue, approximately $1.0 million in licensee income and $471,000 in product revenue for fiscal 2015. The Company reported a net loss in fiscal 2016 of ($1.3) million, or ($0.16) per basic share, compared to net income of $8.1 million, or $0.85 per basic share and $0.83 per diluted share, in fiscal 2015.  The net loss in fiscal 2016 resulted from the cancellation of certain interests in the Florida Revenue Sharing Agreement and certain interests in the Texas Revenue Sharing Agreement resulting in loss on extinguishment of revenue sharing agreements in the amount of $2.3 million, goodwill and intangible assets impairment of $2.0 million, a 19% increase in selling, general and administrative expenses and a 3% increase in cost of sales.  This was offset by a 10% increase in total revenue and an income tax benefit of approximately $1,159,000.  During fiscal 2015, the Company released approximately $8.2 million of its valuation allowance for income taxes. Cash and Cash Equivalent Position             As of November 30, 2016, the Company had cash and cash equivalents of $3.5 million.  The Company’s cash decreased by approximately $652,000 during fiscal 2016, primarily as a result of approximately $10.8 million used for stock repurchases offset by cash flow from operations of approximately $5.0 million and an increase in total debt to approximately $10.2 million. Founded in 1989, Cryo-Cell International, Inc. is the world's first private cord blood bank.  More than 500,000 parents from 87 countries trust Cryo-Cell to preserve their family members' stem cells.  Cryo-Cell's mission is to provide clients with state-of-the-art stem cell cryopreservation services and support the advancement of regenerative medicine. Cryo-Cell operates in a facility that is FDA registered, cGMP-/cGTP-compliant and is licensed in all states requiring licensure. Besides being AABB accredited as a cord blood facility, Cryo-Cell is 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. In addition, Cryo-Cell is ISO 9001:2008 certified by BSI, an internationally recognized, quality assessment organization. Cryo-Cell is a publicly traded company, OTCQB:CCEL. For more information, please visit www.cryo-cell.com. Statements wherein 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 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 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 menstrual stem cell technology license agreements and umbilical cord blood license agreements and their ability to provide the Company with royalty fees, the ability of the reproductive tissue storage to generate new revenues for the Company 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.


Mojica-Henshaw M.P.,University of Utah | jacobson P.,University of Utah | Morris J.,University of Utah | Kelley L.,Cryo Cell International Inc | And 3 more authors.
Cytotherapy | Year: 2013

Background aims: Fetal bovine serum (FBS) is commonly used as a serum supplement for culturing human mesenchymal stromal cells (hMSCs). However, human cells grown in FBS, especially for extended periods, risk potential exposure to bovine immunogenic proteins and infectious agents. To address this issue, we investigated the ability of a novel human platelet serum supplement to substitute for FBS in hMSC cultures. Methods: Platelet lysate-serum (PL-serum) was converted from platelet lysate-plasma (PL-plasma) that was manufactured from pooled platelet-rich plasma (PRP) apheresis units. Growth factor levels and the number of residual intact platelets in PL-serum and PL-plasma were compared with enzyme-linked immunosorbent assays and flow cytometry, respectively. Proliferation responses of hMSCs cultured in PL-serum, PL-plasma, or FBS were assessed with 3-(4,5-dimethylthiazol-2-yl)-2,5-diphenyltetrazolium bromide assay, the immunophenotype of harvested hMSCs was evaluated by flow cytometry and tri-lineage differentiation potential was evaluated by assessing adipogenic, osteogenic and chondrogenic development. Results: Selected growth factor levels in PL-serum were not significantly different from PL-plasma (P > 0.05). hMSC cultures supplemented with PL-serum had comparable growth kinetics to PL-plasma, and hMSC yields were consistently greater than with FBS. hMSCs harvested from cultures supplemented with PL-serum, PL-plasma or FBS had similar cell surface phenotypes and maintained tri-lineage differentiation potential. Conclusions: PL-serum, similar to PL-plasma, can substitute for FBS in hMSC cultures. Use of PL-serum, in contrast to PL-plasma, has an added advantage of not requiring addition of a xenogeneic source of heparin, providing a completely xeno-free culture medium. © 2013 International Society for Cellular Therapy.


Patent
Cryo Cell International Inc., Walton and Allickson | Date: 2013-04-03

Compositions comprising menstrual stem cells (MSCs) and methods, processes, and system therefore are provided by the invention. MSCs are processed from menstrual flow collected during menses. MSCs may be cryopreserved, processed through various culturing and selection steps in preparation for cryopreservation, or processed for therapeutic or cosmeceutical use. Cryopreserved MSCs may be thawed in preparation for therapeutic and cosmeceutical use. MSCs express CD9, CD10, CD13, CD29, CD44, CD49e, CD49f, CD59, CD81, CD105, CD166, and HLA class I, and have low or no expression of CD3 and HLA class II.


Allickson J.G.,Cryo Cell International Inc. | Sanchez A.,Cryo Cell International Inc. | Yefimenko N.,Cryo Cell International Inc. | Borlongan C.V.,University of South Florida | Sanberg P.R.,University of South Florida
Open Stem Cell Journal | Year: 2011

We are in the beginning of the era of regenerative medicine and many researchers are testing adult stem cells to be used for tissue repair and regeneration in the human body. Many adult stem cells have been discovered since the late 1990's with more recently a novel adult stem cell described in menstrual blood. The menstrual blood is derived from shedding of the endometrial lining, specifically the functionalis layer, which contains highly proliferative cells used to prepare the female body for implementation of a fertilized egg. Cell characterization experiments of stromal stem cells discovered in menstrual blood have demonstrated cells to be multipotent which can successfully differentiate in vitro into cell lineages derived from the mesoderm and the ectoderm. When menstrual blood cells were seeded in culture the average number of adherent cells was 8.50 % with a range of 0.48% to 47.76%. Demonstrating longevity one cell line allowed to grow was subcultured 47 times before complete senescence and death. The menstrual blood stromal stem cell phenotypic analysis incorporates mesenchymal cell markers such as CD13, CD29, CD44, CD49f, CD73, CD90, CD105, CD166, MHC Class I and pluripotent embryonic stem cell markers SSEA-4, Nanog and Oct-4. Karyotypic analysis demonstrated the maintenance of diploid cells without chromosomal abnormalities. In conclusion preliminary studies have demonstrated menstrual stem cells are easily expandable to clinical relevance. Pivotal pre-clinical studies are now underway to test the safety and efficacy of menstrual stem cells in several different animal models including one for neuroprotection following transplantation into an experimental stroke model. The study demonstrates menstrual stem cells are a novel cell population that may be routinely and safely isolated to provide a renewable source of stem cells from child-bearing women. © Allickson et al.


Methods are provided for obtaining expanded human cord blood cells or cord tissue cells expressing CD34. The methods involve seeding a sufficient amount of human cord blood cells or cord tissue cells with a sufficient amount of menstrual cells under co-culture conditions suitable to promote expansion of the cord cells, and co-culturing the cord cells with the menstrual cells under culture conditions that support at least two or more population doublings of the cord cells. Methods are also provided for growing expanded human cord cells to give rise to any one of colony forming units, colony forming unit granulocyte macrophages (CFU-GM), burst forming unit erythroids (BFU-E), and colony forming unit granulocyte erythrocyte macrophage megakaryocyte (CFU-GEMM) blood lineage precursor cells. The expanded cells may express CD34, SSEA-4, and HLA-II. Compositions of the expanded cells are also provided.


Trademark
Cryo Cell International Inc. | Date: 2011-09-20

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