Lyophilized platelet rich plasma for the use in wound healing (chronic or acute) and bone or tissue grafts or repair

a technology of lyophilized platelets and lyophilized platelets, which is applied in the direction of biocide, drug composition, peptide/protein ingredients, etc., can solve the problems of affecting the function of lyophilized platelets that have been fixed by such fixative agents in hemostasis, the proper functioning of lyophilized platelets that have been fixed by hemostasis is questionable, and the electroporation is very damaging to the cell membrane, so as to

Inactive Publication Date: 2005-09-01
WALKER MACKIE J JR
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Benefits of technology

[0023] The present invention relates to an improved Lyophilized platelet and plasma composition for wound treatment, a method of making and use thereof. The composition comprises Lyophilized platelets and plasma composition in liquid form to the wound site and will gel to prevent the material from flowing away from the site. Optional antibiotics may be included in the improved composition to prevent infections at the wound site. The presence of the anti-oxidant, including vitamins and non-vitamin anti-oxidants, and other healing promotion materials that do not detract from, substantially interfere with, or even destroy the different thrombin activation reactions. The inventive Lyophilized platelet gels containing fresh plasma is prepared for topical application at the wound site and avoid the requirement for daily reapplication.
[0026] The inventive composition increases the amount of growth factors in the wound, and thereby facilitates the promotion of the healing rate. This may be especially important in “wounded” patients, especially those with chronic wounds who may lack sufficient circulation to facilitate the healing cascade. The invention described herein also facilitates the covering of the wound area with a substance that prevents or helps to reduce infection caused by most bacteria;
[0028] In most general terms, the invention described herein expands the uses for concentrated platelet materials, especially those in gel form, by improving the speed and convenience of making the composition; the invention described herein also improves the performance of the concentrated platelet composition, by making it more useable for applications over longer periods of time, and by enhancing the wound healing and infection fighting properties.
[0029] Another aspect of the present invention involves adding one or more antibiotic substance at one or more times during the processing period so that the resulting concentrated platelet and plasma composition contains either one or a variety of the antibiotics. The use of an antibiotic in concentrated platelet and plasma compositions that enhances the complex healing cascade is indeed novel. The invention disclosed herein involves adding such substances in a manner that does not detract from, substantially interfere with, or even destroy these different reactions, pH balances and potency.

Problems solved by technology

However, a considerable fraction of these cells are partly lysed after thawing and have the shape of a balloon.
Proper functioning of lyophilized platelets that have been fixed by such fixative agents in hemostasis is questionable.
However, electroporation is very damaging to the cell membranes and is believed to activate the platelets.
Activated platelets have dubious clinical value.
Although injury to the surface of the skin is the most well known type of wound, the surfaces of internal organs may also be wounded, such as during surgery, rupture of the spleen or liver, or resulting from traumatic blows to the body surface in the vicinity of an internal organ.
Acute wounds covering a large or movable surface are usually the most difficult to guard from infection, and to heal.
These products form a hard, cast-like covering over the area to be sealed, and tend to be non-yielding to limb movement.
This form of treatment has major problems, like time consuming and problems collecting blood sometimes with expensive machines and disposables.
The chemical reactions and cascades that normally occur when thrombin is added to the concentrated platelets are indeed complex.
There are a number of disadvantages associated with conventional wound compositions derived from platelet concentrates.
Also, certain platelet compositions must be applied to the wound site on a daily basis and thus require regular blood withdrawal from the patient.
This is time consuming and if more of the compositions is needed, then another needle stick is needed and the process time required to make the composition.

Method used

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Examples

Experimental program
Comparison scheme
Effect test

example 1

[0047] Preparation of Lyophilized Platelet Rich Plasma for the use in Wound Healing (Chronic or Acute) and Bone or Tissue Grafts.

[0048] (a) The First Method for Human blood components obtained from a blood bank or collection center:

[0049] The components needed:

[0050] 1. Pooled or single donor platelets (containing at least 5×10 to the 9th platelets) about 40 ml to 50 ml per bag.

[0051] 2. Pooled or single donor fresh frozen plasma (about 250 ml) per bag.

[0052] 3. Centrifuge with the capabilities of spinning 50 ml tubes up to 5000 rpms.

[0053] 4. 50 ml tubes.

[0054] 5. Pipettes from 0.01 ul to 50 ml

[0055] 6. Vials with stoppers and caps.

[0056] Method:

[0057] 1. Remove the platelets from the bag and place in a 50 ml tube and centrifuge for 15-20 min. at 5000 rpms to form a platelet plug, which is known in the art.

[0058] 2. Remove and discard the platelet poor plasma from the tube of platelets.

[0059] 3. Thaw the fresh frozen plasma ad insert an amount into the platelet plug con...

example 2

[0074] (a) The Second Method for Human blood components obtained from a blood bank or collection center:

[0075] The components needed:

[0076] 1. Pooled or single donor platelets (containing at least 5×10 to the 9th platelets) about 40 ml to 50 ml per bag.

[0077] 2. Pooled or single donor fresh frozen plasma (about 250 ml) per bag.

[0078] 3. Centrifuge with the capabilities of spinning 50 ml tubes up to 5000 rpms.

[0079] 4. 50 ml tubes.

[0080] 5. Pipettes from 0.01 ul to 50 ml

[0081] 6. Vials with stoppers and caps.

[0082] 7. GHK-Cu ranging from 0.02 mg / ml to 0.5 mg / ml in liquid form

[0083] Method:

[0084] 1. Remove the platelets from the bag and place in a 50 ml tube and centrifuge for 15-20 min. at 5000 rpms to form a platelet plug, which is known in the art.

[0085] 2. Remove and discard the platelet poor plasma from the tube of platelets.

[0086] 3. Thaw the fresh frozen plasma ad insert an amount into the platelet plug container as to cause a platelet count of between 250,000 to 4,...

example 3

[0215] (a) The sixth method for human or animal, obtained from apheresis either

[0216] Autologous or Homologous:

[0217] The components needed:

[0218] 1. Single donor platelets (obtained from apheresis) about 40 ml to 50 ml per bag.

[0219] 2. Centrifuge with the capabilities of spinning 50 ml tubes up to 5000 rpms.

[0220] 3. 50 ml tubes.

[0221] 4. Pipettes from 0.01 ul to 50 ml.

[0222] 5. Vials with stoppers and caps.

[0223] Method:

[0224] 1. Remove the platelets from the bag of apheresis platelets.

[0225] 2. Add fresh plasma into the platelets in an amount to cause a platelet count of between 250,000 to 4,500,000 platelets per milliliter. Being very careful that the fresh platelet rich plasma does not stay thawed for more than 6 hours.

[0226] 3. Gently rotate back and forth to cause the platelets and plasma to mix well. 4. Pipette the desired amount of PRP into the vials to be lyophilized and place the stoppers in place.

[0227] 5. Lyophilize at once (take care as to not allow any wa...

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Abstract

This invention relates to an improved Lyophilized platelet rich plasma used to make a platelet gel wound healant, and methods of preparation and use thereof for healing wounds are disclosed. The improved wound healant comprises therapeutically effective amounts of activated growth factors, platelet ghost, plasma (know as the plasma back bone), white blood cells with optional none, one or more additional anti-oxidant such as vitamin A and / or C and / or E, and / or none one or more antibiotics and / or GHK-Cu (produced by ProCyte Inc.)

Description

FIELD OF TH INVENTION [0001] This application is based on Provisional application No. 60 / 542,903 Filed Feb. 9, 2004. The invention relates to an improved Lyophilized platelet rich plasma used to make a platelet gel wound healant, and methods of preparation and use thereof for healing wounds are disclosed. The improved wound healant comprises a therapeutically effective amount of activated growth factors with optional none, one or more additional anti-oxidant such as vitamin A and / or C and / or E, and / or one or more antibiotics and / or GHK-Cu (produced by ProCyte Inc.). [0002] The present invention relates to improved Lyophilized platelet rich plasma for the use in wound healing and bone or tissue grafts and methods of making and use thereof of Lyophilized or fixed platelets. [0003] The present invention generally relates to the therapeutic uses of blood platelets and fresh plasma that has been combined and lyophilized, and more particularly to manipulations or modifications of platelet...

Claims

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Application Information

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Patent Type & Authority Applications(United States)
IPC IPC(8): A61K35/14A61K35/16A61K35/19A61K45/00
CPCA61K35/16A61K35/19A61K38/4833A61K2300/00A61P17/02
Inventor GANDY, JAMES BENNIE
Owner WALKER MACKIE J JR
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