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The allografts we use

We work only with FDA-registered tissue banks. The connective tissue allografts we use are derived from donated human umbilical cord (Wharton's jelly) and processed to preserve the structural matrix — for cushioning and structural support, homologous use only.

Sourcing

Where the material comes from

In the U.S., there are limited legal pathways to obtain donated umbilical cord tissue — and they run through FDA-registered facilities. We partner with registered labs for the products we use, including Vitti Labs and Regenative Labs.

Partner lab

Vitti Labs

An FDA-registered tissue bank, AATB-accredited and cGMP-certified, following GTP and WHO protocols. Provides the WJ-PURE+ and EV-PURE+ allografts described below.

Partner lab

Regenative Labs

An FDA-registered manufacturer of cryopreserved Wharton's jelly allografts processed to maintain the naturally occurring extracellular matrix and structural proteins.

Product names and trademarks belong to their respective owners and are referenced here to describe the materials we use. Vitti Labs and Regenative Labs products are FDA-registered, not FDA-approved, and are intended for use by medical professionals.

Animated — What is Wharton’s Jelly? Explainer

Video · 2:18

A short animated explainer covering what Wharton’s jelly is, where it comes from, and how connective tissue allografts are intended to provide cushioning and structural support. Educational only — not medical advice.

What is Wharton’s Jelly? — Informational

Video · 1:19

An informational overview of Wharton’s jelly — what it is, how it is donated and processed, and how allografts are intended to provide cushioning and structural support. Educational only — not medical advice.

Video disclaimer: The videos above are the proprietary property of Regenative Labs and are reproduced here with permission for educational purposes only. All rights, trademarks, and content remain those of Regenative Labs. They are not medical advice, do not constitute a treatment recommendation, and are not intended to diagnose, treat, cure, or prevent any disease. Connective tissue allografts are FDA-registered, not FDA-approved, and are intended for homologous use to provide cushioning and structural support. Individual results vary and are not guaranteed.

Vitti Labs allografts

Two structural tissue options

Both are minimally manipulated, bio-ethical human umbilical cord allografts manufactured under GTP, cGMP, AATB and FDA HCT/P 361 guidelines. Both are DSMO-free, and the proprietary process is free of harmful enzymes and chemicals to preserve integrity.

WJ-PURE+

Micro Matrix HCT/P allograft

A Wharton's jelly connective tissue allograft for homologous use in clinical settings, containing nonconduit structural tissue.

Product option1 ml
MatrixMicro
Lot testing20% sterility & endotoxin
Storage−80°C / shipped on dry ice

EV-PURE+

Nano Matrix HCT/P allograft

A minimally manipulated umbilical cord-harvested allograft containing nonconduit structural tissue, aseptically processed and packaged.

Product options1 ml / 4.5 ml
MatrixNano
Lot testing20% sterility & endotoxin
Storage−80°C / shipped on dry ice

These products may contain live cells but are not dependent on the metabolic activity of living cells for their primary function. They meet the criteria of 21 CFR 1271.10 and are regulated under 21 CFR 1271 and Section 361 of the PHS Act. They are not approved by the FDA and are intended for use by medical professionals only.

Regenative Labs allografts

Two concentration options

Cryopreserved Wharton’s jelly (human umbilical cord) allografts, rich in cytokines, growth factors, and scaffolding proteins. Both are regulated as HCT/Ps under 21 CFR Part 1271 and Section 361 of the Public Health Service Act, and are ethically derived from healthy, consenting mothers following full-term, planned Cesarean deliveries — never from an embryo or fetus.

PURETEXT™

Wharton’s jelly allograft · double concentration

The same product as CryoText™ Pro at double the concentration. It was designed primarily for spinal cases, where providers were previously using two CryoText™ Pro applications.

SKUPURE200-25
Dose2 mL / 300 mg
Concentration150 mg/mL
Designed forSpinal applications

CRYOTEXT PRO™

Wharton’s jelly allograft · standard concentration

A cryopreserved umbilical cord tissue allograft intended to supplement missing or damaged connective tissue in homologous applications, with high concentrations of hyaluronic acid and growth factors.

SKUCYP200-25
Dose2 mL / 150 mg
Concentration75 mg/mL
ApplicationsJoints, tendon & soft tissue

These products are intended for homologous use to supplement missing or damaged connective tissue, as described in 21 CFR 1271.10(a). They are FDA-registered, not FDA-approved, and are not intended to diagnose, treat, cure, or prevent any disease. Individual patient results may vary as not all outcomes are the same. Product names and specifications are the property of Regenative Labs.

Quality & safety

Screened, tested, and standards-driven

Before any allograft is used, the donation moves through a regulated chain of screening and testing. A few of the safeguards built in:

Healthy, consenting donors

Tissue is donated following healthy, full-term deliveries with the mother's informed consent.

Donor & tissue screening

Mothers and cord tissue are thoroughly screened for infectious disease, sterility and endotoxins.

AATB standards

Handling meets the standards of the American Association of Tissue Banks.

CLIA-certified lab

Processing takes place in a CLIA-certified laboratory under the Clinical Laboratory Improvement Amendments of 1988.

Regulatory framework

How these products are classified

The allografts we use are human cells, tissues, and cellular/tissue-based products (HCT/Ps), regulated under Section 361 of the Public Health Service Act and 21 CFR Part 1271. To qualify for the 361 pathway, a product must meet all four criteria below.

01

Minimally manipulated

Processing doesn't alter the tissue's original relevant characteristics for reconstruction, repair or replacement.

02

Homologous use only

It performs the same basic function in the recipient as in the donor — here, cushioning and structural support.

03

No impermissible additives

Combined only with water, crystalloids, or a permitted sterilizing, preserving or storage agent.

04

Not disease-marketed

Not dependent on the metabolic activity of living cells for its primary function, and not marketed to treat disease.

In the donor, Wharton's jelly cushions and structurally supports the umbilical cord vessels. In the recipient, it does the same basic structural job — cushioning and support — at the site where it's applied.

  • This is exactly why we frame everything around cushioning and support. Our allografts are FDA-registered, not FDA-approved, and are not currently approved to treat any disease.
Why patients consider this

What cushioning and support can mean

People explore connective tissue allografts for different reasons. Framed honestly, here's what this option is — and isn't — built to do. None of this is a promise of results, and a licensed provider will tell you if it isn't a fit.

Cushioning where it's been lost

Supplements missing or damaged connective tissue, adding structural cushioning and support at the site of a defect.

Targeted and local

Placed exactly where support is needed and intended to stay there — roughly 98% remains in the treated area. It isn't systemic.

Minimally invasive

A shallow, ultrasound-guided application rather than surgery. Some patients have reported little to no downtime.

An option to understand

Many people want to learn about non-surgical options before considering bigger steps. This is one option to understand — with no obligation.

Connective tissue allografts are intended to provide cushioning and structural support for homologous use only. They are FDA-registered, not FDA-approved, and are not intended to diagnose, treat, cure, or prevent any disease, to reduce inflammation, or to avoid surgery. Individual results vary and are not guaranteed; not all outcomes are the same, and all medical procedures carry potential risks and side effects. See our full disclosures.

Questions about the products?

Let's talk it through

Cushion. Support. Move.

Reserve a complimentary consultation, or attend a free seminar to learn how connective tissue allografts provide cushioning and structural support.