Stem Cells Current Classification

FDA Guidance for Industry

What Does N-Graft® Do For the Skin?

Regulatory Considerations for Human Cells, Tissues and Cellular Tissue-based products (HCT/P): Minimal Manipulation and Homologous Use

December 2017
HCT/Ps are defined in 21 CFR 1271 as articles containing human cells or tissues that are intended for implantation, transplantation, infusion, or transfer into a human recipient.
HCT/Ps may perform multiple functions and FDA acknowledges that these structural tissues can also contain cells.

FDA is authorized to apply the requirements in the Federal Food, Drug and Cosmetic Act (FD&C Act) and the Public Health Service Act (PHS Act) to those products that meet the definition of drug, biologic or devise, under this tiered, risk based approach, those HCT/Ps that meet specific criteria or fall within detailed exceptions do not require premarket review and approval.

There are certain “tissue rules” issued by the FDA through notice and comment rulemaking, under the communicable disease authority of section 361 of the PHS Act (42 U.S.C.264)

“In 21 CFR 1271.10, the regulations identify the criteria for regulation solely under section 361 of the PHS Act and 21 CFR Part 1271. An HCT/P is regulated solely under section 361 of the PHS Act and 21 CFR Part 1271 if it meets all of the following criteria:

1)The HCT/P is minimally manipulated;

2)The HCT/P is intended for homologous use only, as reflected by the labeling, advertising, or other indications of the manufacturer’s objective intent;

3)The manufacture of the HCT/P does not involve the combination of the cells or tissues with another article, except for water, crystalloids, or a sterilizing, preserving, or storage agent, provided that the addition of water, crystalloids, or the sterilizing, preserving, or storage agent does not raise new clinical safety concerns with respect to the HCT/P; and

4)Either:

i)The HCT/P does not have a systemic effect and is not dependent upon the metabolic activity of living cells for its primary function

or

ii)The HCT/P has a systemic effect or is dependent upon the metabolic activity of living cells for its primary function, then it is considered a drug, devise or biologic product under the FD&C Act and falls under section 351 and applicable regulations.

and:

a)Is for autologous use;

b)Is for allogeneic use in a first-degree or second-degree blood relative; or

c)Is for reproductive use.

Minimal Manipulation:

For structural tissue, processing does not alter the original relevant characteristics relating to the tissue’s utility for reconstruction, repair or replacement.

For cells, processing that does not alter the relevant biological characteristics of cells or tissues.

Homologous Use:

Defined in CFR 1271.3, homologous use means the repair, reconstruction, replacement or supplementation of a recipient’s cells or tissues with an HCT/P that performs the same basic functions in the recipient or donor.
Repair, Reconstruction, replacement and supplementation are not mutually exclusive functions and an HCT/P could perform more than one of these functions for a given intended use.

 

Repair, physical or mechanical restoration of tissues

Reconstruction, surgical reassembling or re-forming

Replacement, substitution of a missing tissue or cell

Supplementation generally means to add to, or complete.

For example, FDA would consider the implantation of dermal matrix into facial wrinkles to supplement a recipient’s tissue and the use of bone chips to supplement bony defects as homologous use.

If an HCT/P is intended for use as an unproven treatment for a myriad of diseases or conditions, the HCT/P is likely not intended for homologous use only.

Learn About N-Graft®

For the first time ever, you can attain a younger, more beautiful face without plastic surgery! The N-Graft® procedure is internationally patented, minimally invasive, and proven to reverse the effects of aging in patients. While other cosmetic approaches seek to simply restore lost volume or replenish collagen temporarily, N-Graft® uses stem cells to multiply fibroblasts (the cells that make collagen) in order to stimulate continual collagen production in your dermis. Our unique procedure is designed to revive the vitality of your skin and give you a youthful appearance you’ll love for life!

N-Graft® & Botox

Our nonsurgical, office-based N-graft procedure not only stimulates your current collagen, but also uses fibroblasts (the cells that make collagen) to increase new collagen and elastin density in skin, giving you a fresh, natural glow that lasts. It can enhance your beauty as a standalone technique or serve as the perfect complement to Botox if crow’s feet or forehead wrinkles are your concern. Talk to your aesthetician to find out if N-Graft® is right for you!

N-Graft® & Fillers

N-Graft® treats the underlying cause of volume loss by rekindling the creation of fibroblasts, which are the cells that make collagen. If you want to hydrate your skin, lighten hyperpigmentation, minimize wrinkles, diminish smile lines, and more, then N-Graft® is the solution! This non-invasive procedure can lead to these desired effects by itself or enhance these effects with fillers by helping them smooth the appearance of your skin faster. Talk with your provider to learn why N-Graft® is the best way to restore bright, clear-looking skin!

N-Graft® & Facelifts

Our team at N-Graft® Cosmetics can reverse the facial aging process in conjunction with facial surgery by restoring the elasticity of your skin and reducing the depth and number of wrinkles, while a facelift will eliminate excess skin that is more severely damaged. Our process, which multiplies fibroblasts (cells that make collagen) in your dermis, can achieve visible results working alongside a facelift procedure to help you heal faster! Talk with your surgeon to find out how N-Graft® can give you a youthful appearance.

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What Our Patients Are Saying

"Our unique method of engrafting stem cells into the skin’s dermal layer changes this microenvironment, increasing the number of these “skin cells” or fibroblasts that were lost over time. The increased number cells cause a dramatic increase in collagen and elastin density in the dermis."

Locations

Contact

Main Office

2202 N. Westshore Blvd, Suite 140
Tampa, FL 33607

P: 813-489-6644

E: info@ngraftcosmetics.com