Reparative cell isolation and delivery
Inventors
Altman, Andrew M • Alt, Eckhard U. • Coleman, Michael E.
Assignees
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Publication Number
US-11369716-B2
Publication Date
2022-06-28
Expiration Date
Abstract
Methods are described for generating autologous tissue grafts, including generating grafts at the point of care, which include isolated cell populations that are enriched with stem cells and are mixed with biological fillers including hyaluronic acid and derivatives thereof. The hyaluronic acid localizes the cells to a desired injection site and stimulates collagen production thus enhancing the viability and the longevity of the graft.
Core Innovation
The patent describes point-of-care methods and compositions for treating or preventing tendon damage in a mammal by using an autologous stromal vascular cell population isolated from lipoaspirate or adipose tissue. The isolated population is prepared without centrifugation or plastic adherence and without culture or expansion in culture, by enzymatic dissociation or by releasing cells from a connective tissue matrix and substantially removing connective tissue, debris, and adipocytes, to provide a mixed stromal vascular fraction population for immediate injection or implantation at the point-of-care.
The isolated autologous stromal vascular cell population includes cells expressing markers associated with stemness. In one described approach, 3-10% of the isolated autologous stromal vascular cell population expresses markers associated with stemness including one or more of CXCR4, Oct-4, sca-1, SSEA-4, VEGFr, CD146, and CD117. The patent also describes exposing the isolated autologous SVF cell preparation to inductive media prior to injection or implantation.
A further aspect is combining the isolated autologous cell preparation with a biological filler, including hyaluronic acid, hyaluronic acid derivatives, and/or a collagen agent, with cross-linked hyaluronic acid stated in at least one embodiment. The patent states that HA/HAD localizes injected cells to the site and stimulates collagen production, and provides experimental support including collagen/procollagen expression and graft integration/engraftment at injection sites in a UV photoaging mouse model.
Claims Coverage
The independent claims cover point-of-care tendon-damage treatments using autologous stromal vascular cell preparations isolated without centrifugation or plastic adherence, with defined stemness-marker coverage, optional exposure to inductive media, and optional administration together with a biological filler including hyaluronic acid and/or hyaluronic acid derivatives and/or collagen. Across the independent claims, the inventive features focus on point-of-care non-cultured isolation and injection/implantation, stemness-associated marker fraction or marker sets, inductive-media exposure, and biological-filler combination.
Point-of-care non-cultured SVF isolation and tendon injection without centrifugation or plastic adherence
Isolating, at a point-of-care and without the use of centrifugation or plastic adherence, an autologous stromal vascular cell population by enzymatic dissociation of lipoaspirate and removal of connective tissue and debris, and injecting the isolated autologous stromal vascular cell population into an area of a tendon at the point-of-care without culture of the autologous stromal vascular cell population.
Stemness-associated marker expression in the isolated autologous stromal vascular cell population
Providing that 3-10% of the isolated autologous stromal vascular cell population express markers associated with stemness including one or more of CXCR4, Oct-4, sca-1, SSEA-4, VEGFr, CD146, and CD117.
Inductive-media exposed, non-cultured autologous SVF graft prepared and administered at point-of-care
Isolating, without the use of plastic adherence, an autologous stromal vascular fraction cell preparation by releasing cells from a connective tissue matrix of the adipose tissue and substantially removing debris and adipocytes without subjecting the autologous stromal vascular cell preparation to expansion in culture, exposing the isolated autologous stromal vascular cell preparation to inductive media, and injecting or implanting the isolated autologous stromal vascular cell preparation into an area of a tendon at the point-of-care without culturing.
Mixed stromal vascular cell graft implanted at point-of-care together with a biological filler
Isolating a mixed population of stromal vascular cells from a lipoaspirate of a patient at the point-of-care by releasing cells from the lipoaspirate and removing connective tissue and debris without culture and without plastic adherence, said mixed population including multi-potent progenitor cells, endothelial cells, and fibroblasts, and implanting the mixed population of stromal vascular cells into a tendon area of the patient together with a biological filler, the mixed population of cells and the biological filler together constituting a cell graft implanted into the patient at the point-of-care.
Biological filler co-administration with autologous stromal vascular cell populations
Implanting or injecting the isolated autologous stromal vascular cell population or mixed population into a tendon area together with a biological filler, where the biological filler includes hyaluronic acid, a hyaluronic acid derivative, and/or a collagen agent.
The independent claims require point-of-care isolation of autologous stromal vascular cells or SVF from lipoaspirate or adipose tissue without expansion in culture and without plastic adherence, and in one claim without centrifugation, followed by injection or implantation into a tendon area without culturing. The claims also cover stemness-associated marker expression, including a defined 3-10% range and named marker identities, and further cover optional inductive-media exposure and administration together with a biological filler including HA, HAD, and/or collagen.
Stated Advantages
Stated stimulation of collagen production associated with use of hyaluronic acid and/or hyaluronic acid derivatives.
Improved localization of injected cells to the site associated with hyaluronic acid and/or hyaluronic acid derivatives.
Documented Applications
Point-of-care treatment or prevention of tendon damage in a mammal using autologous stromal vascular cell populations isolated from lipoaspirate and injected into a tendon area.
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