Clinical applications of formulations containing adipose-derived stem cells
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Publication Number
US-9956317-B2
Publication Date
2018-05-01
Expiration Date
Abstract
Methods and kits for producing cellular fractions enriched in adipose derived stem cells. Methods are provided where adipose tissue obtained from liposuction is enzymatically treated using a solution containing collagenase and divalent cations prior to the application of traditional methods of stromal-vascular fraction isolation. The enzymatic solutions may contain collagenase types I and II to a final concentration of about 0.001 mg/ml to 0.010 mg/ml. The divalent cations may be present as calcium, magnesium, and zinc chloride. The final concentration of calcium, magnesium, and zinc may range from about 0.001 to 0.1 micromolar; about 0.005 to 0.5 micromolar; and about 0.0015 to 0.15 micromolar, respectively. The enzymatic solutions may be generated using a kit where the collagenase and divalent components are held in separate containers until just prior to use. The cellular fractions isolated in this manner may be used in autologous fat grafts in therapeutic applications.
Core Innovation
The invention provides formulations, methods, and kits for enzymatically processing patient lipoaspirate to produce an adipose-derived stem cell (ADSC)-enriched stromal vascular fraction (SVF). Adipose tissue obtained from a patient by aspiration is combined with an enzymatic solution that includes collagenase and divalent cations including calcium, zinc, and magnesium. The resulting digested adipose tissue is centrifuged to form a centrifugate, and a stromal vascular fraction is isolated from the centrifugate.
The enzymatic solution includes collagenase and divalent cations characterized by specified concentration ranges for calcium, zinc, and magnesium. The processing enriches for a heterogeneous SVF that includes adipose-derived stem cells and other cell populations. The isolated SVF is mixed with a volume of adipose tissue obtained from the patient to form a fat graft for subsequent use.
The disclosed approach is used for autologous administration in clinical indications including fat graft augmentation and therapeutic applications. The document describes use for breast augmentation/reconstruction, wound healing, and osteoarthritis, including injection into an osteoarthritic joint with imaging guidance. The disclosed formulations and kits can include collagenase and cation components stored separately and combined shortly before digestion.
Claims Coverage
The partial content provides three independent claims. Across the independent claims, there are three main inventive features: isolation of an ADSC-enriched cellular fraction from patient aspirated adipose tissue using collagenase plus specified divalent cation concentrations, and downstream use of the isolated stromal vascular fraction (and/or fat graft formed therefrom) for the recited indications.
Enzymatic isolation of an ADSC-enriched cellular fraction from patient aspirated adipose tissue
Obtaining adipose tissue from a patient by aspiration; combining the adipose tissue with an enzymatic solution that includes collagenase and divalent cations including calcium at a concentration from about 0.001 to about 0.1 micromolar, zinc at a concentration from about 0.0015 to about 0.15 micromolar, and magnesium at a concentration of about 0.005 to about 0.05 micromolar; digesting for a period of time sufficient to allow digestion; centrifuging to form a centrifugate; and isolating a stromal vascular fraction from the centrifugate.
Fat graft formation by mixing SVF with additional patient adipose tissue for breast augmentation
Mixing the stromal vascular fraction with a volume of adipose tissue obtained from the patient to form a fat graft.
Administering an SVF for wound healing
Administering the stromal vascular fraction to a wound on the patient.
Injecting SVF into an osteoarthritic joint
Injecting the stromal vascular fraction into the osteoarthritic joint.
All independent claims share the same core isolation concept: enzymatically digesting patient aspirated adipose tissue with collagenase and specified calcium, zinc, and magnesium concentrations to obtain an SVF enriched in adipose-derived stem cells. The independent claims then differentiate by the therapeutic use: forming a fat graft for breast augmentation, administering SVF to a wound, or injecting SVF into an osteoarthritic joint.
Stated Advantages
Improved stability is claimed up to about 5 years for the disclosed fat graft use.
Documented Applications
Breast augmentation (including breast augmentation/reconstruction) using a fat graft formed by mixing an SVF with additional adipose tissue and injecting the fat graft into breasts of the patient.
Wound healing by administering the stromal vascular fraction to a wound on the patient.
Treatment of an osteoarthritic joint by injecting the stromal vascular fraction into the osteoarthritic joint, including imaging guidance during injecting.
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