Nonexpansion Protocol for Autologous Cell-Based Therapies
The present application describes various applications of the non-expansion protocol for the preparation of an injectable autologous cell mixture of the present invention that can be used to prevent symptoms in a number of indications. Cells are isolated from surgically derived tissue and are at least partially disaggregated from each other. The heterologous cell mixture is mixed with growth factors, differentiation agents, extracellular matrix proteins and/or microspheres and injected into the patient without cell expansion. The harvesting of tissue, cell isolation, and injection are performed within a single surgical procedure lasting only minutes to hours.
1 . A method for treating a pelvic tissue anomaly in a patient, comprising:
obtaining a portion of tissue from a patient isolating cells within said tissue;
disaggregating at least a portion of said cells within said tissue, wherein said steps of isolating and disaggregating produce a heterologous cell mixture;
combining said heterologous cell mixture with a mixing agent to produce an injectable solution;
injecting said injectable solution into said patient proximate the pelvic tissue anomaly, wherein each of said steps is performed during a single medical procedure and wherein said single medical procedure is performed within a time period of one minute to five hours.
2 . The method according to claim 1 , wherein the said method is performed without the steps of culturing and isolating a specific cell population.
3 . A method according to claim 1 , wherein the cells are autologous.
4 . A method according to claim 1 , wherein the cells are not passaged.
5 . The method of claim 1 , wherein said mixing agent is selected from a group comprising: a physiologically acceptable medium, a growth factor, a differentiation agent, an extracellular matrix protein, microspheres or other non-cellular agents that would provide an initial bulking effect and/or improve cell survival, or a combination of one or more of the mixing agents.
6 . The method according to claim 4 , wherein the growth factor is a member of a growth factor family selected from a group consisting of the VEGF family, the FGF family, the EGF family, the IGF family, and the TGF-beta family.
7 . The method according to claim 4 , wherein the growth factor is selected from the group consisting of basis fibroblast growth factor (b-FGF), insulin-like growth factor-1 (IGF-1), nerve growth factor (NGF), and brain-derived neurotrophic factor (BDNF).
8 . The method according to claim 4 , wherein the extracellular matrix protein is selected from the group consisting of collagen, fibronectin, laminin, vitronectin, heparin, heparan sulfate, chondroitin sulfate, dermatan sulfate, and hyaluronate.
9 . The method according to claim 4 , wherein the microspheres or bulking agents are selected from a group consisting of poly(lactic-co-glycolic acid), polylactic acid, polyglycolic acid, poly(orthoesters), polyanhydrides, polycaprolactone, polyhydroxybutyrate, polyethylene terephthalate, polyarylates, polylactic acid-polyethylene glycol copolymer, poly(lactic-co-glycolic acid)-polyethylene oxide copolymer, polydioxanone, poly-trimethylene carbonate, polyester amides, polyglycolic acid-co-trimethylene carbonate, polyhydroxy butyrate valerate, polyphophagenes, polyurethane, silicone, carbon biospheres, polystyrene, polyvinyl acetate, chitosan, alginate, albumin, and polyamino acids.
10 . The method of claim 1 , wherein said pelvic tissue anomaly for treatment is selected from a group comprising:
urinary incontinence (stress, urge, mixed, neurogenic, overflow);
fecal incontinence;
prolapse;
erectile dysfunction;
interstitial cystitis;
urinary retention disorder;
female sexual dysfunction;
male sexual dysfunction;
pelvic pain;
pelvic pain and organic dysfunction;
prostatalgia;
cancer; and
abnormal uterine bleeding.