Biologic composition and method of use
Inventors
Ganey, Timothy • Namin, Shabnam • Temple, Harry Thomas
Assignees
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Publication Number
US-12558455-B2
Publication Date
2026-02-24
Expiration Date
Abstract
A biologic composition responsive to inflammation has an allograft scaffold matrix for injection or implantation. The allograft scaffold matrix has donor quiescent and/or senescent cells. The donor quiescent and/or senescent cells react in response to signaling of inflammation from host cells or matrix. The reaction to signaling causes the donor quiescent and/or senescent cells to secrete anti-inflammatory cytokines and secrete exosomes to initiate regeneration of the area of the inflammation. The biologic composition further has a cryoprotectant. The cryoprotectant is a polyampholyte, preferably the polyampholyte is an ε-poly-L-lysine. The cryoprotectant is not DMSO or glycerol based. The cryoprotectant is suitable for direct implantation without washing from the allograft scaffold matrix in either a diluted or non-diluted state.
Core Innovation
The invention relates to a biologic composition responsive to inflammation that comprises donor quiescent and senescent cells pre-treated with a non-glycerol, non-Dimethyl Sulfoxide (DMSO) cryoprotectant of polyampholyte. The donor quiescent and senescent cells are at rest or dormant at the time they are cryoprotected, enabling the cells to be maintained without activation prior to use.
The composition further includes an allograft scaffold matrix configured for injection or implantation. The allograft scaffold matrix is made of bone, cartilage, nucleus pulposus, or dermis material and is provided in the form of chips, fibers, or particles, or combinations thereof. The donor quiescent and senescent cells in the cryoprotectant are seeded onto or loaded into the allograft scaffold matrix, so the inflammation-responsive cells are presented together with a tissue-derived scaffold.
Upon exposure to host inflammation signaling, the preconditioned donor cells are described as activated to secrete anti-inflammatory cytokines and exosomes and/or microvesicles. This activation is associated with reduced inflammation and initiation of regeneration of a degenerated area, with a disc-focused embodiment using micronized freeze-dried nucleus pulposus delivered via injection or implantation.
Claims Coverage
The partial claim set includes one independent claim. This independent claim covers an inflammation-responsive biologic composition combining donor quiescent and senescent cells maintained at rest or dormant with a non-glycerol, non-DMSO polyampholyte cryoprotectant and an injectable or implantable allograft scaffold matrix made from specified tissue materials.
Inflammation-responsive biologic composition with donor quiescent and senescent cells at rest or dormant
A biologic composition responsive to inflammation comprising donor quiescent and senescent cells pre-treated with a non-glycerol, non-Dimethyl Sulfoxide (DMSO) cryoprotectant of polyampholyte, wherein the donor quiescent and senescent cells are at rest or dormant.
Injectable or implantable allograft scaffold matrix of specified tissue material forms
An allograft scaffold matrix in the form of chips, fibers, or particles or combinations thereof configured for injection or implantation, wherein the allograft scaffold matrix is made of bone, cartilage, nucleus pulposus, or dermis material.
Loading cryoprotected donor cells into the allograft scaffold matrix
Wherein the donor quiescent and senescent cells in the cryoprotectant are seeded onto or loaded into the allograft scaffold matrix.
The independent claim establishes a composition that couples non-glycerol, non-DMSO polyampholyte cryoprotected donor quiescent and senescent cells maintained at rest or dormant with an injectable or implantable allograft scaffold matrix made from bone, cartilage, nucleus pulposus, or dermis, with the cryoprotected cells seeded onto or loaded into the matrix.
Stated Advantages
Reduces inflammation.
Initiates regeneration of a degenerated area.
Restores disc height over a described multi-month period.
Documented Applications
Disc-focused regeneration for a degenerative intervertebral disc, including restoration of disc height over a described multi-month period.
Treatment of degenerative conditions in inflamed degenerated areas, where host inflammation signaling activates donor quiescent and senescent cells to reduce inflammation and initiate regeneration.
Broader applicability to other inflammatory degenerative conditions and tissue types, as stated in the document.
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