# US 11,110,128 B2 · Cell preparations for extemporaneous use, useful for healing and rejuvenation in vivo

> Agents: this data is available as JSON from the patentgrep API and MCP server — see https://patentgrep.com/llms.txt

- Number: US 11,110,128 B2
- Document ID: US11110128B2
- Status: Granted
- Kind: B2
- Application number: 17/017,165
- Filed: 2020-09-10
- Published: 2020-12-31
- Granted: 2021-09-07
- Earliest claimed: 2006-08-21
- Assignees: RegenLab USA LLC
- Applicants: RegenLab USA LLC
- Inventors: Antoine Turzi; Donald Du Toit
- Web page: https://patentgrep.com/patent/US11110128B2

## CPC

- A61K 35/19: Platelets; Megacaryocytes
- A61K 8/981: {of mammals or bird}
- A61K 8/983: {Blood, e.g. plasma}
- A61K 35/14: Blood; Artificial blood (perfluorocarbons A61K31/02; umbilical cord blood A61K35/51; haemoglobin A61K38/42)
- A61K 35/15: Cells of the myeloid line, e.g. granulocytes, basophils, eosinophils, neutrophils, leucocytes, monocytes, macrophages or mast cells; Myeloid precursor cells; Antigen-presenting cells, e.g. dendritic cells (presenting a specific antigen A61K39/00; therapeutic combinations of antibodies, or fragments thereof, and blood-derived cells A61K39/00)
- A61K 35/16: Blood plasma; Blood serum (umbilical cord blood A61K35/51)
- A61K 35/18: Erythrocytes (haemoglobin A61K38/42)
- A61K 35/28: Bone marrow; Haematopoietic stem cells; Mesenchymal stem cells of any origin, e.g. adipose-derived stem cells
- A61K 35/30: Nerves; Brain; Eyes; Corneal cells; Cerebrospinal fluid; Neuronal stem cells; Neuronal precursor cells; Glial cells; Oligodendrocytes; Schwann cells; Astroglia; Astrocytes; Choroid plexus; Spinal cord tissue
- A61K 35/32: Bones; Osteocytes; Osteoblasts; Tendons; Tenocytes; Teeth; Odontoblasts; Cartilage; Chondrocytes; Synovial membrane
- A61K 35/34: Muscles; Smooth muscle cells; Heart; Cardiac stem cells; Myoblasts; Myocytes; Cardiomyocytes (vascular smooth muscle A61K35/44)
- A61K 35/35: Fat tissue; Adipocytes; Stromal cells; Connective tissues (adipose-derived stem cells A61K35/28; collagen A61K38/39)
- A61K 35/36: Skin; Hair; Nails; Sebaceous glands; Cerumen; Epidermis; Epithelial cells; Keratinocytes; Langerhans cells; Ectodermal cells (islets of Langerhans A61K35/39)
- A61K 35/38: Stomach; Intestine; Goblet cells; Oral mucosa; Saliva
- A61K 35/39: Pancreas; Islets of Langerhans (Langerhans cells of epidermis A61K35/36)
- A61K 35/51: Umbilical cord; Umbilical cord blood; Umbilical stem cells
- A61K 38/363: {Fibrinogen}
- A61K 38/4833: {Thrombin (3.4.21.5)}
- A61L 24/0005: {Ingredients of undetermined constitution or reaction products thereof}
- A61L 24/106: {Fibrin; Fibrinogen}
- A61L 26/0042: {Fibrin; Fibrinogen}
- A61L 26/0057: {Ingredients of undetermined constitution or reaction products thereof}
- A61L 27/3691: {characterised by physical conditions of the treatment, e.g. applying a compressive force to the composition, pressure cycles, ultrasonic/sonication or microwave treatment, lyophilisation}
- A61L 27/3886: {comprising two or more cell types}
- A61M 1/3693: {using separation based on different densities of components, e.g. centrifuging}
- A61P 17/02: for treating wounds, ulcers, burns, scars, keloids, or the like
- A61Q 19/00: Preparations for care of the skin
- A61Q 19/08: Anti-ageing preparations
- A61K 2300/00: Mixtures or combinations of active ingredients, wherein at least one active ingredient is fully defined in groups A61K31/00 - A61K41/00
- A61K 2800/87: Application Devices; Containers; Packaging
- A61L 2430/02: for reconstruction of bones; weight-bearing implants
- A61M 2202/0427: Platelets; Thrombocytes
- C12Y 304/21005: Thrombin (3.4.21.5)
- A61K: PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES (devices or methods specially adapted for bringing pharmaceutical products into particular physical or administering forms A61J3/00; chemical aspects of, or use of materials for deodorisation of air, for disinfection or sterilisation, or for bandages, dressings, absorbent pads or surgical articles A61L; soap compositions C11D)
- A61L: METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES (preservation of bodies or disinfecting characterised by the agents employed A01N; preserving, e.g. sterilising, food or foodstuffs A23; preparations for medical, dental or toiletry purposes A61K)
- A61M: DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY (introducing media into or onto the bodies of animals A61D7/00; means for inserting tampons A61F13/26; devices for administering food or medicines orally A61J; containers for collecting, storing or administering blood or medical fluids A61J1/05); DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY (surgery A61B; chemical aspects of surgical articles A61L); DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR {(Electrotherapy, e.g. producing anaesthesia by the use of alternating or intermittent currents A61N1/36021)}
- A61P: SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61Q: SPECIFIC USE OF COSMETICS OR SIMILAR TOILETRY PREPARATIONS
- C12Y: ENZYMES

## Abstract

The present invention relates to new plasma or new platelet-rich plasma preparations, new cell dissociation methods, new cell associations or compositions, a method of preparation thereof, a use thereof, devices for the preparation thereof and preparations containing such a platelet-rich plasma preparation and cell associations or compositions. Specifically, the invention provides plasma or platelet-rich plasma alone or in cell composition preparations for use in tissue regeneration and bone regeneration and pain reduction.

## Claims

### Claim 1

A sterilized, vacuum-sealed separator tube for preparing a platelet concentrate from whole blood comprising:
An inlet adapted to introduce whole blood;
An anticoagulant;
A non-toxic and non-mutagenic thixotropic gel; and
wherein, when the separator tube is at least partially filled with the whole blood and centrifuged at a force of about 1,500 g up to about 2,000 g for about 3 to about 10 minutes once in a single centrifugation, blood components in the whole blood are separated into a platelet concentrate to be administered without supernatant removal to a patient, and red blood cells, wherein the platelet concentrate contains greater than 400 billion platelets per liter,
wherein the thixotropic gel forms a barrier between the platelet concentrate and red blood cells.

### Claim 2 (depends on 1)

The separator tube according to claim 1, wherein the separator tube has a usable vacuum of from about 8 to about 10 mL.

### Claim 3 (depends on 1)

The separator tube according to claim 1, further comprising a cap selected from a bromobutylene rubber stopper and a chlorobutylene rubber stopper.

### Claim 4 (depends on 3)

The separator tube according to claim 3, wherein the cap further comprises a polyethylene cover.

### Claim 5 (depends on 1)

The separator tube according to claim 1, wherein the separator tube is pre-filled with the thixotropic gel first to form a layer of thixotropic gel.

### Claim 6 (depends on 5)

The separator tube according to claim 5, wherein the anticoagulant is sprayed onto the inner surface of the separator tube or layered on the thixotropic gel.

### Claim 7 (depends on 1)

The separator tube according to claim 1, wherein the red blood cell concentration is less than about 0.6×1012 red blood cells per liter without supernatant removal.

### Claim 8 (depends on 1)

The separator tube according to claim 1, wherein the platelet concentrate has a white blood cells concentration of at least about 2.8×109 per liter without supernatant removal.

### Claim 9 (depends on 1)

The separator tube according to claim 1, wherein the platelet concentrate has a fibrinogen concentration of at least about 3 mg/L without supernatant removal.

### Claim 10 (depends on 1)

The separator tube according to claim 1, wherein the platelet concentrate has a hemoglobin concentration of about 0.4 g/dL without supernatant removal.

### Claim 11 (depends on 1)

The separator tube according to claim 1, consisting essentially of:
An inlet adapted to introduce whole blood;
An anticoagulant; and
A non-toxic and non-mutagenic thixotropic gel.

### Claim 12 (depends on 1)

A method of preparing the separator tube according to claim 1, comprising:
Providing a separator tube having an inlet;
Adding the thixotropic gel to the separator tube to form a first layer inside the separator tube;
Adding the anti-coagulant;
Sterilizing the separator tube, thixotropic gel, and anti-coagulant;
Creating a vacuum within the separator tube; and
Hermetically sealing the separator tube with a cap thereby preparing the separator tube of claim 1.

### Claim 13 (depends on 12)

The method according to claim 12, wherein sterilizing comprises irradiation or steam.

### Claim 14 (depends on 12)

The method according to claim 12, wherein creating a vacuum within the separator tube comprises creating a vacuum having a usable vacuum of from about 8 to about 10 mL.

### Claim 15 (depends on 12)

The method according to claim 12, wherein the cap is selected from a bromobutylene rubber stopper and a chlorobutylene rubber stopper.

### Claim 16 (depends on 12)

The method according to claim 12, wherein the cap further comprises a polyethylene cover.

### Claim 17

A sterilized, vacuum-sealed separator tube for preparing a therapeutic platelet concentrate from whole blood comprising:
An inlet adapted to introduce whole blood;
An anticoagulant; and
A thixotropic gel;
wherein, when the separator tube is at least partially filled with the whole blood and centrifuged at a force of about 1,500 g up to about 2,000 g for about 3 to about 10 minutes once in a single centrifugation, blood components in the whole blood are separated into (i) a therapeutic platelet concentrate obtained with supernatant removal and to be administered to a patient, and (ii)red blood cells, wherein the therapeutic platelet concentrate contains greater than about 570 billion platelets per liter and less than about 0.6×1012 red blood cells per liter,
wherein the thixotropic gel forms a barrier between the platelet concentrate and red blood cells as a result of the centrifugation.