Thirumala S.,General Biotechnology, Llc |
Goebel W.S.,General Biotechnology, Llc |
Goebel W.S.,Indiana University |
Woods E.J.,General Biotechnology, Llc
Expert Opinion on Biological Therapy | Year: 2013
Introduction: Mesenchymal stem cells (MSC) and MSC-like cells hold great promise and offer many advantages for developing effective cellular therapeutics. Current trends indicate that the clinical application of MSC will continue to increase markedly. For clinical applications, large numbers of MSC are usually required, ideally in an off-the-shelf format, thus requiring extensive MSC expansion ex vivo and subsequent cryopreservation and banking. Areas covered: To exploit the full potential of MSC for cell-based therapies requires overcoming significant cell-manufacturing, banking and regulatory challenges. The current review will focus on the identification of optimal cell source for MSC, the techniques for production scale-up, cryopreservation and banking and the regulatory challenges involved. Expert opinion: There has been considerable success manufacturing and cryopreserving MSC at laboratory scale. Surprisingly little attention, however, has been given to translate these technologies to an industrial scale. The development of cost-effective advanced technologies for producing and cryopreserving commercial-scale MSC is important for successful clinical cell therapy. © 2013 Informa UK, Ltd.
General Biotechnology, Llc | Date: 2015-09-29
Disclosed are cellular compositions and methods relating to the use of aqueous trehalose media to suspend cells. A trehalose-containing medium can be used to inhibit cellular clumping, for example upon dilution of more concentrated cellular preparations into the trehalose-containing medium. In certain embodiments cells, after cryopreservation and thawing, are combined with a trehalose-containing medium to prepare a clumping-inhibited cell suspension.
General Biotechnology, Llc | Date: 2012-03-12
Compositions and methods for culturing therapeutic cells are provided herein. According to at least one embodiment, compositions comprising cord blood plasma and lysed platelets and methods for making and using same are provided herein.
General Biotechnology, Llc | Date: 2014-08-27
The present disclosure provides a composition comprising a bioactive fraction derived from a platelet concentrate, methods of making the bioactive fraction, and culture medium supplemented with the bioactive fraction. Preferred bioactive fractions have relatively low fibrinogen concentrations while retaining native growth factors in beneficial amounts and ratios.
General Biotechnology, Llc | Date: 2015-01-08
An auto-nucleating device includes a tube containing a crystalline cholesterol matrix. The ends of the tube are closed by a membrane that is impermeable to the cholesterol but permeable to liquids contained in a cryopreservation vessel. The auto-nucleating device provides a site for ice nucleation during freezing of the liquid within the vessel. One such cryopreservation vessel is a flexible vial having a closed port at one adapted to be pierced by a needle to withdraw the liquid within, and an opposite end that is initially open to receive the liquid. Another vessel includes an adaptor mounted to liquid container with a tubular branch closed by a needle septum and another tubular branch provided with a barbed fitting for engaging a flexible tube that terminates in a needle septum. In another embodiment, the vessel includes an inlet and vent branch at the top of the container and an outlet septum at a bottom opening.
General Biotechnology, Llc | Date: 2016-09-30
A method for treating preselected diseases comprising the steps of providing a therapeutic dose of a mesenchymal stem cell composition, the mesenchymal stem cell composition comprising mesenchymal stem cells harvested from at least one tissue selected from the group consisting of placental tissue, bone marrow, dental tissue, testicle tissue, and dermal tissue; and systemically administering the mesenchymal stem cell composition to the patient suffering from a preselected disease or diseased state through an intravenous injection.
General Biotechnology, Llc | Date: 2014-02-14
Agency: Department of Health and Human Services | Branch: | Program: SBIR | Phase: Phase I | Award Amount: 142.44K | Year: 2010
DESCRIPTION (provided by applicant): Therapeutic Angiogenesis by Universal Donor Endometrial Regenerative Cells (ERC) Abstract The proposed study seeks to develop a practical, off the shelf, universal donor, cell therapy for an advanced form of peripheral artery disease termed critical limb ischemia (CLI). The major problem facing CLI patients is lack of proper circulation to the extremities. Although a basal level of collateral vessel formation has been documented in these patients, in many cases it is insufficient to prevent amputation. Methods of augmenting the process of collateral vessel formation through administration of angiogenic cytokines have largely failed clinically [1-3]. One explanation for this has been that cytokine administration was performed under conditions that were not physiological, both in terms of sequence and combinations. A more therapeutically promising method has been administration of autologous stem cells which secrete angiogenic cytokines under what appears to be more physiological conditions. Numerous clinical trials have demonstrated benefit using bone marrow and mobilized peripheral blood stem cell populations, which are reviewed in the following reference . Unfortunately, adult autologous cells display reduced angiogenic capacity, especially in CLI patients [5, 6]. Additionally, the procedures for harvesting stem cells from the bone marrow or peripheral blood are considered to be dangerous in patients with CLI due to existing comorbidities [7, 8]. From a practical perspective autologous therapy can only be performed at specialized centers which have certified clean rooms and experience with cell processing. A novel stem cell population termed endometrial regenerative cells (ERC) has been identified by Medistem, Inc., that the company is developing with General BioTechnology, LLC as a universal donor population. To date this collaboration has resulted in a cell population that inhibits inflammatory responses, do not elicit T cell reactivity, and can survive in allogeneic and xenogeneic hosts in absence of immune suppression both in vitro and in vivo. Given the large amount of angiogenic growth factor secretion and ability to stimulate angiogenesis, the ERC may be a commercially viable substitute for autologous stem cell implantation that circumvents the problems of: extraction, age and disease associated stem cell dysfunction, and requirement for clean room facilities at the point of care. The current proposal seeks support to expand on existing efficacy evaluation so as to permit entry into Phase Ib/II clinical trials. PUBLIC HEALTH RELEVANCE: The project aims to augment existing safety and manufacturing data to submit a Phase Ib/II IND for treatment of critical limb ischemia using a novel adult stem cell population developed by Medistem termed Endometrial Regenerative Cells (ERC). Existing data demonstrates ERC are potently angiogenic, anti-inflammatory, and can be used in a universal donor manner, thus providing an easy to use, off the shelf cellular therapy for a condition that lacks therapeutic options besides amputation.
Agency: Department of Health and Human Services | Branch: | Program: SBIR | Phase: Phase I | Award Amount: 154.28K | Year: 2011
DESCRIPTION (provided by applicant): The overall goal of this proposal is to design and develop a type of cryopreservation media and an easy-to-use cooling device that allow the long-term storage and safe shipment of animal model germplasm (embryos and spermatozoa) and embryonic stem cells (ESCs) at -80oC. Storage and maintenance of valuable genotypes of animal model species as live animal lines would be wholly impractical [Critser,2000]. Banking lines as cryopreserved germplasm and ESCs, and restoring of these cells into live, reproductive viable animals is routine in many laboratories and animal resource centers across the world. However, due to the use of liquid nitrogen (LN2), LN2 dewars and complicated cooling devices, storage and shipment of these cryopreserved cells is a large burden to the daily operation of these institutes. Therefore, lowering the cost of these procedures will save hundreds of thousands of dollars annually. In this proposal, we plan to develop an aqueous solution with cryoprotectants (CPAs) that is thermodynamically stable at temperatures as high as -80oC, so that the cryopreserved samples can be stored and shipped using conventional -80oC freezers and dry ice, respectively. An inexpensive, easy-to-use, self-nucleating cooling system will also be produced to further lower the associated costs and improve the outcomes of these procedures. To achieve these aims, we propose the following Specific Aims: For Phase I: (I) Design and develop a cryopreservation media that is thermodynamically stable at -80oC; (II) Empirically test the efficacy of the new cryopreservation media by cryopreserving rodent germplasm and ESCs. For Phase II: (III) Design and develop a novel, easy-to-use cooling device that will provide defined constant cooling rates and automatic seeding for the media developed in Phase I; (IV) Determine the efficacy of cryopreserving rodent germplasm and ESCs at - 80oC using the developed device and media. At the end, the proposed device and media will be produced under appropriateengineering design control and validated through biophysical tests. PUBLIC HEALTH RELEVANCE: Cryopreservation of animal model germplasm and embryonic stem cells is of critical importance for biomedical research. The overall goal of this proposal isto develop a cryopreservation media and an easy-to-use device that allow these cell types to be cooled and stored in a -80oC freezer for a long time and safely shipped on dry ice. These approaches will completely avoid the use of liquid nitrogen or complicated cooling devices, and significantly reduce the associated costs for the storage and shipment of the cryopreserved cells.
General Biotechnology, Llc | Date: 2014-02-24
A fluid sample vessel includes inlet and vent tube fittings formed at one end of a container with an opposite open end closed by a needle septum. A support cap is removably engaged to the container to support the container and protect terminal ends of inlet and vent tubular branches coupled to the fittings. The support cap includes a pair of opposite legs with outwardly directed tabs for mounting within a centrifuge while supporting the cryopreservation container.