Method and apparatus for production of a skin graft and the graft produced thereby

• US 20070183974A1
• Filed: 11/05/2002
• Published: 08/09/2007
• Est. Priority Date: 11/05/2001
• Status: Abandoned Application

• Current Assignee: Medgenics Inc. (Avalo Therapeutics, Inc.)
• Original Assignee: Medgenics Inc. (Avalo Therapeutics, Inc.)
• Inventors: Pearlman, Andrew
• Application Number:
  US10/494,244
• Publication Number:
  US 20070183974A1
• Time in Patent Office: Days
• US Class Current: 424/9.100
• CPC Class Codes: A61B 17/322 Skin grafting apparatus
• CPC Class Codes: A61B 2017/3225 with processing of harvested tissue
• CPC Class Codes: A61K 2300/00 Mixtures or combinations of active ingredients, wherein at least one active ingredient is fully defined in groups A61K31/00 - A61K41/00
• CPC Class Codes: A61K 35/36 Skin; Hair; Nails; Sebaceous glands; Cerumen; Epidermis; Epithelial cells; Keratinocytes; Langerhans cells; Ectodermal cells islets of Langerhans A61K35/39
• CPC Class Codes: A61K 38/1816 Erythropoietin [EPO]
• CPC Class Codes: A61K 38/212 IFN-alpha
• CPC Class Codes: A61K 47/6901 Conjugates being cells, cell fragments, viruses, ghosts, red blood cells or viral vectors
• CPC Class Codes: A61P 37/00 Drugs for immunological or allergic disorders
• CPC Class Codes: C12M 21/08 for producing artificial tissue or for ex-vivo cultivation of tissue prostheses A61F2/00, grafts A61L27/00
• CPC Class Codes: C12M 35/08 Chemical, biochemical or biological means, e.g. plasma jet, co-culture
• CPC Class Codes: C12M 45/02 by mechanical forces; Stirring; Trituration; Comminuting crushing, pulverizing, disintegrating in general B02C

Abstract

A micro-organ structure comprising at least two micro-organ portions formed from a tissue, in which said at least two micro-organs are linked one to the other by means of a junction formed from said tissue of which the micro-organs were formed therefrom.

Claims

1-72. -72. (canceled)

73. A method of determining the amount of a therapeutic micro-organ to be implanted in a patient, the method comprising:

determining a secretion level of a therapeutic agent by a quantity of the micro-organ in vitro;

estimating a relationship between in vitro secretions and in vivo serum levels of the therapeutic agent; and

determining an amount of therapeutic micro-organ to be implanted, based on the determined secretion level and the estimated relationship.

74. A method according to claim 73, wherein the relationship is estimated, based one or more factors chosen from the following group of factors:

a) Subject data such as weight, age, physical condition, clinical status;

b) Pharmacokinetic data from previous TMO administration to other similar subjects; and

c) Pharmacokinetic data from previous TMO administration to that subject.

75. A method according to claim 74, wherein the relationship is estimated based on at least two of said factors.

76. A method according to claim 74, wherein the relationship is based on three of said factors.

77. A method according to claim 74, wherein determining an amount of a therapeutic micro-organ to be implanted in a patient is also based on one or both of:

corresponding amounts of the same therapeutic protein routinely administered to such subjects based on regulatory guidelines, specific clinical protocols or population statistics for similar subjects; and

corresponding amounts of the same therapeutic agent specifically to that same subject in the case the he/she has received it via injections or other administration routes previously.

78. A method according to claim 73 further including preparing an amount of therapeutic micro-organ for implantation, in accordance with the determined amount.

79. A method of implanting a micro-organ in a patient comprising:

advancing a catheter beneath the skin surface from said puncture;

inserting an elongate carrier having a micro-organ attached thereto at a known position thereon, into and through the catheter so that it exits the surface of the tissue;

positioning the carrier such that the micro-organ is at a known position within the catheter under the surface of the tissue; and

removing the catheter while holding the micro-organ in position.

80. A method of implanting a micro-organ in a patient comprising:

aspirating a micro-organ into a needle

inserting said needle through the skin at a known position

removing the needle while holding the micro-organ in position.

81. A method according to claim 80, wherein the micro-organ is a genetically altered therapeutic micro-organ that excretes a therapeutic agent.

82. A method of adjusting the dosage of a therapeutic agent produced by a therapeutic micro-organ implanted in a subject and excreting a therapeutic agent, comprising:

(a) monitoring level of therapeutic agent in the subject;

(b) comparing the level of agent to a desired level;

(c) if the level is lower than a minimum level, then implanting additional therapeutic micro-organ; and

(d) if the level is higher than a maximum level, then inactivating or removing a portion of the implanted micro-organ.

83. A method according to claim 82 further including periodically repeating (a)-(d).

84. A method according to claim 82, wherein inactivating or removing consists of removing a portion of the implanted micro-organ.

85. A method according to claim 82, wherein removing comprises surgical removal.

86. A method according to claim 82, wherein inactivating comprises killing a portion of the implanted micro-organ.

87. A method according to claim 82, wherein inactivating comprises ablating a portion of the implanted micro-organ.