Native soft tissue matrix for therapeutic applications

Abstract

A product for implantation within a soft tissue site of the human or animal body comprises a pulverized or morselized matrix of a substantially non-mineralized native soft tissue (NSTM) of the human or animal body, provided in a therapeutic amount to induce growth of native tissue or organs and healing at the tissue site. The NSTM is composed of at least one soft tissue selected from the group consisting of cartilage, meniscus, intervertebral disc, ligament, tendon, muscle, fascia, periosteum, pericardium, perichondrium, skin, nerve, blood vessels, and heart valves or from organs such as bladder, lung, kidney, liver, pancreas, thyroid, or thymus. Preferably, the NSTM is composed of a soft tissue of the same type of tissue native to the repair site. In another embodiment, the NSTM includes soft tissue of a different type than the tissue repair site.

Description

BACKGROUND OF THE INVENTION [0001] The present invention relates to the repair, replacement and / or regeneration of diseased or traumatized soft tissue. [0002] Tissue and organ failure represents a major socioeconomic burden and has been estimated to cost the economy over $400 billion per year. Numerous approaches are being developed in an effort to promote the repair or regeneration of tissues or organs. Recent studies suggest that the introduction of autologous or allogeneic tissues, with or without the addition of biologically active molecules such as growth factors, may have the ability to promote new tissue formation and serve as a material for cellular infiltration and tissue repair in the body. For example, Urist and co-workers have shown the potential for the induction of bone in ectopic sites such as muscle by the implantation of demineralized bone powder. See, Urist et al., Bone formation in implants of partially and wholly demineralized bone matrix, Clin. Orthop. 71:271-8 ...

AI Technical Summary

Benefits of technology

[0006] One important aspect of the present invention is to process soft tissue from specific sites in the body in a manner that produces pulverized morsels of the soft tissue devoid of immunogenic material and pathogens but with intact aspects of the composition of the extracellular matrix proteins including the growth factors and cytokines that are responsible for tissue growth and cellular infiltration and differentiation. This pulverized soft tissue in the form of morsels, hereafter Native Soft Tissue Matrix or NSTM, may be implanted or injected at the needed site(s) in the body. Alternatively, the NSTM may be combined with other known biomaterials, which are biologic, synthetic or a combination of the two prior to therapeutic use. The resulting composite, taking the form of a slurry or paste, may then be implanted or injected at the needed site(s) in the body. Alternatively, the NSTM composite can be reconstituted as a tissue scaffold to promote the ex vivo regeneration of various tissues which can then be implanted in the body. The development of a variety of biomaterial matrices that are biologic, synthetic or a combination of the two based on specific tissues of the body will provide an efficient and effective approach for promoting tissue repair using either cellular or acellular approaches.

Problems solved by technology

Tissue and organ failure represents a major socioeconomic burden and has been estimated to cost the economy over $400 billion per year.

While this approach suggested by Urist et al. has proven valuable for applications involving bone regeneration and repair, a similar approach is not available for the repair of soft tissues such as cartilage, meniscus, intervertebral disc, muscle, tendon / ligament, blood vessels, nerve, or other tissues.

The repair of these soft tissues following degeneration, disease, or injury remains a major challenge to the medical field.

In such cases, there is often a need to replace missing or damaged tissues with functional tissue replacements.

Autogenous tissue is often limited in availability and is generally associated with significant donor site morbidity.

Fresh allograft tissues are associated with significant risks of disease transmission, while intact but radiation sterilized allografts suffer a loss of biomechanical function and generally do not support repopulation by the host's cells, and therefore show limited long-term success.

Synthetic implants, on the other hand, have a limited fatigue life and often introduce problems of wear or integration in the body.

Previous approaches have also implanted intact allograft tissues, but have shown minimal host cell infiltration, and thus significant tissue necrosis and degradation occurs over time.

Thus, there are no satisfactory approaches currently available for the long-term repair of soft tissue injury or disease.