Tissue-derived tissugenic implants, and methods of fabricating and using same

• US 8,834,928 B1
• Filed: 07/23/2013
• Issued: 09/16/2014
• Est. Priority Date: 05/16/2011
• Status: Active Grant

• Current Assignee: Musculoskeletal Transplant Foundation
• Original Assignee: Musculoskeletal Transplant Foundation
• Inventors: Truncale, Katherine Gomes, Gertzman, Arthur A., Huang, Yen-Chen, Yannariello-Brown, Judith, Semler, Eric, Chnari, Evangelia, Dasgupta, Anouska, Riley, Terri
• Primary Examiner(s): BERTOGLIO, VALARIE E
• Application Number:
  US13/948,798
• Time in Patent Office: 420 Days
• Field of Search: None
• US Class Current: 424/484
• CPC Class Codes: A61L 2300/414 Growth factors
• CPC Class Codes: A61L 2430/02 for reconstruction of bones; weight-bearing implants
• CPC Class Codes: A61L 27/3604 characterised by the human or animal origin of the biological material, e.g. hair, fascia, fish scales, silk, shellac, pericardium, pleura, renal tissue, amniotic membrane, parenchymal tissue, fetal tissue, muscle tissue, fat tissue, enamel
• CPC Class Codes: A61L 27/3608 Bone, e.g. demineralised bone matrix [DBM], bone powder
• CPC Class Codes: A61L 27/3804 characterised by specific cells or progenitors thereof, e.g. fibroblasts, connective tissue cells, kidney cells
• CPC Class Codes: A61L 27/3847 Bones
• CPC Class Codes: C12N 2533/90 Substrates of biological origin, e.g. extracellular matrix, decellularised tissue
• CPC Class Codes: C12N 5/0605 Cells from extra-embryonic tissues, e.g. placenta, amnion, yolk sac, Wharton's jelly
• CPC Class Codes: C12N 5/0653 Adipocytes; Adipose tissue
• CPC Class Codes: C12N 5/0654 Osteocytes, Osteoblasts, Odontocytes; Bones, Teeth
• CPC Class Codes: C12N 5/0663 Bone marrow mesenchymal stem cells (BM-MSC)

Abstract

The disclosure provides implants containing a plurality of particles containing at least one population of viable tissuegenic cells adherent to and resident in the growth-conductive matrix or at least viable population of tissuegenic cells caused to be in contact with the growth-conductive matrix; methods to fabricate implants; methods of fabricating the implants; and use of the implants in tissue repair.

Claims

1. A method of fabricating a tissue-derived implant for implantation in a recipient allogeneic to a donor of the implant, the method comprising steps:

(a) isolating a tissue comprising at least one tissue-derived growth-conductive matrix from which measurable immunologically reactive hematopoietic cells have been removed, wherein the growth-conductive matrix comprises at least one viable population of nonexpanded tissuegenic cells endogenous to the growth conductive matrix of the donor that remain adherent to and resident in an endogenous milieu of the growth-conductive matrix;

(b) separating the at least one tissue-derived growth-conductive matrix from the tissue of step (a) to generate a plurality of separated matrix pieces comprising the at least one viable population of nonexpanded tissuegenic cells endogenous to the growth conductive matrix of the donor that remain adherent to and resident in the endogenous milieu of the growth-conductive matrix, wherein the tissuegenic cells in the separated matrix pieces is of a relative frequency substantially similar to that found in the growth matrix of step (a);

(c) rinsing the plurality of the separated matrix pieces of step (b) to form a plurality of rinsed separated matrix pieces comprising the at least one viable population of nonexpanded tissuegenic cells endogenous to the growth conductive matrix of the donor that remain adherent to and resident in the endogenous milieu of the growth-conductive matrix of step (b), wherein the tissuegenic cells in the rinsed separated matrix pieces of step (c) is of a relative frequency substantially similar to that found in the growth-conductive matrix of step (a), with the proviso that, before implantation, the implant is not reconstituted with cells exogenous to the tissue-derived growth conductive matrix of the donor;

(d) collecting the plurality of the rinsed separated matrix pieces of step (c) comprising the at least one viable population of nonexpanded tissuegenic cells endogenous to the growth conductive matrix of the donor that remain adherent to and resident in the endogenous milieu of the growth-conductive matrix of step (c), wherein the at least one viable tissuegenic cell population in the collected rinsed separated matrix pieces is of a relative frequency substantially similar to that found in the growth-conductive matrix of step (a); and

(e) packaging the plurality of the collected rinsed separated matrix pieces of step (d) comprising at least one viable population of nonexpanded tissuegenic cells endogenous to the growth conductive matrix of the donor that remain adherent to and resident in the endogenous milieu of the growth-conductive matrix, wherein the at least one viable tissuegenic cell population is of a relative frequency substantially similar to that found in the growth-conductive matrix of step (a), to form the implant.

2. The method according to claim 1, wherein steps (a)-(d) are carried out at a temperature of about 4°

C. to about 10°

C.

3. The method according to claim 1, wherein the at least one tissue-derived growth-conductive matrix is derived from a tissue selected from the group consisting of an adipose tissue, an amnion tissue, an artery tissue, a bone tissue, a cartilage tissue, a chorion tissue, a colon tissue, a dental tissue, a dermal tissue, a duodenal tissue, an endothelial tissue, an epithelial tissue, a fascial tissue, a gastrointestinal tissue, a growth plate tissue, an intervertebral disc tissue, an intestinal mucosal tissue, an intestinal serosal tissue, a ligament tissue, a liver tissue, a lung tissue, a mammary tissue, a meniscal tissue, a muscle tissue, a nerve tissue, an ovarian tissue, a parenchymal organ tissue, a pericardial tissue, a periosteal tissue, a peritoneal tissue, a placental tissue, a skin tissue, a spleen tissue, a stomach tissue, a synovial tissue, a tendon tissue, a testes tissue, an umbilical cord tissue, a urological tissue, a vascular tissue, a vein tissue, and a combination thereof.

4. The method according to claim 1, wherein the growth-conductive matrix and the tissuegenic cells are derived from a bone tissue.

5. The implant according to claim 4, wherein the bone tissue comprises a cancellous bone, a cortical bone, or a combination thereof.

6. The implant according to claim 4, wherein the bone tissue comprises a cancellous bone.

7. The method according to claim 6, wherein the cancellous bone is selected from the group consisting of a calcaneus, a distal femur bone, a proximal femur, a proximal humerus, an ilium, a patella, a distal tibia, a proximal tibia, a scapula, a cancellous bone from a sternum, a talus, at least one vertebral body, and a combination thereof.

8. The method according to claim 4, wherein the bone tissue comprises a cortical bone.

9. The method according to claim 4, wherein the bone tissue comprises periosteal tissue.