US2018028575A1PendingUtilityA1

Methods and compositions for treatment of penile defects

58
Assignee: ZAHALSKY MICHAELPriority: Jan 30, 2012Filed: Feb 8, 2016Published: Feb 1, 2018
Est. expiryJan 30, 2032(~5.5 yrs left)· nominal 20-yr term from priority
Inventors:Michael P. Zahalsky
A61K 35/48A61K 9/0034A61K 47/42A61K 9/0024A61K 38/24A61L 27/3633A61L 27/58C12N 5/0683A61L 27/3834A61K 38/27A61K 31/568A61L 2300/414A61L 2400/06A61L 27/54A61K 35/50A61K 38/4886A61K 38/39A61L 27/52C12N 5/0667A61L 27/24A61L 27/225A61K 38/18A61K 35/545A61K 35/35A61K 35/28C12N 5/00A61L 2300/41A61K 45/06A61K 38/09A61K 35/16A61K 9/0019
58
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Claims

Abstract

Compositions for use in treating penile defects, including erectile dysfunction and Peyronie's disease. Compositions include penile stem cells and isolated penile stem cells substantially free of red blood cells, additives such as amnion, amniotic fluid, extracellular matrix components, growth factors, anti-inflammatories, antioxidants, wound healing agents, and collagenases. Also provided are methods of treating said penile defects in a patient, including implanting a composition of penile stem cells or platelet rich plasma derived from the penis into a patient. Methods include implanting a composition of amnion and/or amniotic fluid into a patient for a penile defect. Also provided are methods of isolating penile stem cells substantially free of red blood cells by providing a whole blood specimen obtained from the penis of a subject; separating the whole blood into fractions containing penile stem cells and the red blood cells from the specimen; and collecting the penile stem cell fraction.

Claims

exact text as granted — not AI-modified
1 . A composition comprising: a population of isolated penile stem cells substantially free of red blood cells. 
     
     
         2 . The composition according to  claim 1 , further comprising testosterone, human chorionic gonadotropin (hCG), human growth hormone (HGH), somatropin or a combination thereof. 
     
     
         3 . (canceled) 
     
     
         4 . The composition according to  claim 1 , further comprising at least one extracellular matrix component. 
     
     
         5 . The composition according to  claim 4 , wherein the extracellular matrix component comprises collagen. 
     
     
         6 . The composition according to  claim 1 , further comprising at least one growth factor. 
     
     
         7 . (canceled) 
     
     
         8 . (canceled) 
     
     
         9 . (canceled) 
     
     
         10 . (canceled) 
     
     
         11 . The composition according to  claim 1 , wherein the composition further comprises blood plasma or platelet rich plasma from the penis. 
     
     
         12 . The composition according to  claim 11 , wherein the isolated penile stem cells and the blood plasma or platelet rich plasma are derived from a cadaver. 
     
     
         13 . The composition according to  claim 1 , further comprising non-penile stem cells, wherein the non-penile stem cells are pericytes. 
     
     
         14 . (canceled) 
     
     
         15 . The composition according to  claim 1 , further comprising amnion, amniotic fluid or both. 
     
     
         16 . The composition according to  claim 1 , wherein the stem cells are derived from tissue from a biopsy of the penis. 
     
     
         17 . The composition according to  claim 1 , wherein the stem cells are derived from a biopsy or blood and is obtained with a spreading needle that decreases the risk of corporal injury. 
     
     
         18 . (canceled) 
     
     
         19 . The composition according to  claim 1 , further comprising a biological scaffolding, wherein the scaffolding is biodegradable wherein the scaffolding is time release or viscous. 
     
     
         20 . (canceled) 
     
     
         21 . (canceled) 
     
     
         22 . The composition according to  claim 1 , further comprising at least one additional agent wherein the agent promotes at least one of wound healing, angiogenesis, vasculogenesis, and degradation of collagen. 
     
     
         23 . (canceled) 
     
     
         24 . The composition of  claim 22 , wherein the agent is an anti-inflammatory or an antioxidant. 
     
     
         25 . A method of treating a subject with a penile defect comprising the steps of: implanting an effective amount of a composition within the penis of a subject in need of treatment for a penile defect. 
     
     
         26 . The method of  claim 25 , wherein the implanting step comprises injecting the composition into the subject. 
     
     
         27 . The method of  claim 26 , wherein the composition is injected into or around at least one of the subject's corpora cavernosa or wherein the composition is injected into or around the tunica albuginea. 
     
     
         28 . (canceled) 
     
     
         29 . The method of  claim 26 , wherein the composition is injected as a spray. 
     
     
         30 . The method of  claim 25 , wherein the composition is formulated and implanted as a gel or a putty. 
     
     
         31 . The method of  claim 25 , wherein the stem cells comprise autologous stem cells. 
     
     
         32 . The method of  claim 25 , wherein the stem cells are derived from a cadaver. 
     
     
         33 . The method of  claim 25 , wherein the stem cells from the subject or a donor or a cadaver are plated and cultured and then injected or reinjected. 
     
     
         34 . The method of  claim 25 , wherein the defect is Peyronie's disease, or the defect is erectile dysfunction or the defect is a penile trauma or priapism. 
     
     
         35 . (canceled) 
     
     
         36 . (canceled) 
     
     
         37 . A method of isolating penile stem cells substantially free of red blood cells: providing a whole blood specimen obtained from the penis of a subject;
 separating the whole blood into fractions, wherein one fraction contains penile stem cells and a second fraction containing substantially all of the red blood cells from the specimen; and   collecting the fraction containing the penile stem cells.   
     
     
         38 . The method of  claim 37 , further comprising the step of obtaining the whole blood specimen from the subject's penis. 
     
     
         39 . The method of  claim 38 , wherein the specimen is obtained while the subject's penis is erect. 
     
     
         40 . (canceled) 
     
     
         41 . The method of  claim 37 , wherein the separating step comprises centrifuging the specimen, wherein the fraction containing the penile stem cells comprises platelet rich plasma. 
     
     
         42 . (canceled) 
     
     
         43 . The method of  claim 37 , further comprising the step of adding amnion, amniotic fluid or both to the fraction containing the penile stem cells. 
     
     
         44 . The method of  claim 37 , further comprising the step of adding testosterone, human chorionic gonadotropin (hCG), human growth hormone (HGH), somatropin or a combination thereof to the fraction containing the penile stem cells. 
     
     
         45 . The method of  claim 37 , further comprising the step of adding at least one extracellular matrix component and at least one growth factor. 
     
     
         46 . The method of  claim 45 , wherein the extracellular matrix component comprises collagen. 
     
     
         47 . The method of  claim 41 , further comprising the step of reinjecting the penile stem cells obtained from the subject's penis back into that subject's penis. 
     
     
         48 . A method of treating a subject with a penile defect comprising the steps of: implanting an effective amount of a composition comprising amnion, amniotic fluid or both within the penis of a subject in need of treatment for a penile defect. 
     
     
         49 . (canceled) 
     
     
         50 . (canceled) 
     
     
         51 . (canceled) 
     
     
         52 . The method of  claim 8 , wherein the composition is injected as a spray. 
     
     
         53 . The method of  claim 48 , wherein the composition is formulated and implanted as a gel or a putty. 
     
     
         54 . The method of  claim 48 , wherein the defect is Peyronie's disease, or the defect is erectile dysfunction or the defect is a penile trauma or priapism. 
     
     
         55 . (canceled) 
     
     
         56 . (canceled) 
     
     
         57 . The method of  claim 48 , wherein the composition further comprises testosterone, human chorionic gonadotropin (hCG), human growth hormone (HGH), somatropin or a combination thereof. 
     
     
         58 . (canceled) 
     
     
         59 . The method of  claim 48 , wherein the composition further comprises at least one extracellular matrix component and at least one growth factor and wherein the composition comprises testosterone, human chorionic gonadotropin (hCG), human growth hormone (HGH), somatropin or a combination thereof. 
     
     
         60 . (canceled) 
     
     
         61 . The method of  claim 59 , wherein the extracellular matrix component comprises collagen. 
     
     
         62 . The method of  claim 48 , wherein the composition further comprises blood plasma or platelet rich plasma from the penis. 
     
     
         63 . (canceled) 
     
     
         64 . The method of  claim 62 , wherein the blood plasma or platelet rich plasma is derived from a cadaver. 
     
     
         65 . The method of  claim 48 , wherein the composition further comprises a biological scaffolding, wherein the scaffolding is biodegradable. 
     
     
         66 . (canceled) 
     
     
         67 . The method of  claim 65 , wherein the scaffolding is time release or viscous. 
     
     
         68 . The method of  claim 48 , wherein the composition further comprises at least one additional agent, wherein the agent promotes at least one of wound healing, angiogenesis, vasculogenesis, and degradation of collagen and wherein the agent is an anti-inflammatory or an antioxidant. 
     
     
         69 . (canceled) 
     
     
         70 . (canceled)

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