Answers, in plain terms

We're a precision-medicine practice founded by a physician and a group of entrepreneurs, built around education first. We use connective tissue allografts to provide cushioning and structural support in and around the joints, and we teach patients about every option before any treatment is discussed. Our clinic is in Del Mar, California, and we currently operate in California and Washington.

An MD and two nurse practitioners oversee every consultation and good-faith exam. Our education officers are professional public speakers who travel to communities to teach — but only licensed providers evaluate candidacy and apply allografts.

Yes. Concierge care is available to every patient: you can be seen by the same licensed providers you'd see in clinic, held to the same clinical standards. Scheduling, the good-faith exam and follow-ups are coordinated around you.

Each patient is different. The goal is to address the affected area in a single treatment. For more severe degeneration, some patients work with their provider on multiple applications.

A visit averages 45–120 minutes. The application itself is quick, depending on how many areas are addressed; consultation and prep are tailored to you, and some patients have reported little to no downtime.

Some patients have noted changes over 3–12 months, though individual timelines vary. Verbal follow-ups through the first year help chart your progress. Individual results vary and are not guaranteed.

No. This is a structural tissue allograft. It is not reliant on living cells for its primary function, so there is nothing intended to grow or differentiate into other tissue. It provides cushioning and structural support at the site where it's applied.

Because the processed allograft is largely acellular, blood-type matching isn't required. These tissues are known for immune-privileged properties, and removing cellular material significantly reduces the risk of immune rejection.

Umbilical cord tissue has been studied and collected for over 30 years. These allografts are FDA-registered, not FDA-approved; published studies to date have mostly been small or unblinded, and several larger randomized controlled trials are now underway. You can browse a curated list on our Clinical Studies page, and thousands more are available on PubMed.gov.

Donors are thoroughly screened for risk factors and communicable disease, with a careful medical and social history collected in advance. Tissue undergoes extensive medical, social, and blood testing before processing; only tissue cleared by that screening is processed and re-tested under American Association of Tissue Banks (AATB) and FDA standards. Testing follows the Clinical Laboratory Improvement Amendments of 1988 (CLIA) and 42 CFR Part 493, and every step of manufacturing is verified end to end.

Yes. The manufacturers we work with collaborate with universities on third-party analyses — for example, mass-spectrometry studies characterizing the structural components of Wharton's jelly before and after processing — to verify that the relevant structural characteristics are preserved.

We use products from FDA-registered tissue banks with strong compliance records. Ask us for current documentation for the specific products used in your care, and you can confirm any manufacturer's FDA registration yourself using the FDA's public establishment database.

A soft, gel-like connective tissue found inside the umbilical cord. Its natural role is structural and protective — it cushions and insulates the cord's blood vessels. It's made up largely of water, collagen fibers, hyaluronic acid, and naturally present growth and signaling factors.

For regulatory purposes, structural tissues are those that physically support, serve as a barrier or conduit, or connect, cover or cushion in the donor. Examples include bone, skin, amniotic membrane and umbilical cord, blood vessel, adipose tissue, cartilage, and tendon or ligament. Their meaningful characteristics include support, strength, flexibility, cushioning, covering and compressibility.

Structural tissues may contain both extracellular matrix and cellular components. Under the regulations, an HCT/P is treated as either a structural tissue or a cellular/nonstructural tissue; tissues that support, cover, cushion, or act as a barrier or conduit are generally treated as structural. The products we use may contain live cells, but they do not depend on the metabolic activity of living cells for their primary function — that function is structural: cushioning and support.

We use Wharton's jelly connective tissue allografts from FDA-registered partner labs. These include Vitti Labs' WJ-PURE+ (a Micro Matrix HCT/P allograft, 1 ml) and EV-PURE+ (a Nano Matrix HCT/P allograft, 1 ml or 4.5 ml). Both are minimally manipulated, bio-ethical, DSMO-free, and processed without harmful enzymes or chemicals to preserve integrity. See our Products & Science page for detail.

20% of every lot is sent for sterility and endotoxin testing by a third-party laboratory, and products are aseptically processed and packaged. They're stored frozen (commonly at −80°C / −112°F) and shipped on dry ice, kept frozen until use or expiration. Properly stored, Wharton's jelly allografts can have a multi-year shelf life.

We don't manufacture tissue ourselves. We use products from FDA-registered tissue banks (such as Vitti Labs and Regenative Labs) that are responsible for the steps after recovery — processing, testing, storage, labeling, packaging, and distribution — under GTP, cGMP, AATB and FDA HCT/P 361 standards.

Birth-tissue products regulated under Section 361 — primarily Wharton's jelly (umbilical cord-derived) allografts intended for homologous use to provide cushioning and structural support, and amniotic membrane products intended for homologous use as a covering or barrier.

Yes. Wharton's jelly is processed and reduced to a size that can flow through a syringe while preserving its original relevant structural characteristics — its ability to cushion and support. Universities have studied the structural properties of Wharton's jelly in the donor and verified that those same properties are present in the processed allograft.

PRP is prepared from a small sample of your own blood, which is concentrated so that it contains a higher proportion of platelets. Platelets naturally carry growth factors that are released at the site when the preparation is applied, with the aim of supporting your body’s own natural processes. PRP uses your own blood and is not a drug; it is not FDA-approved to diagnose, treat, cure, or prevent any disease. Individual results vary and are not guaranteed.

Most patients tolerate the procedure well. Because PRP works with your body’s own inflammatory response, some soreness, swelling, or tenderness at the site is common in the first day or two. Your provider will review what to expect and options for managing any discomfort. Experiences vary from person to person.

Responses to PRP vary from person to person, and any changes typically develop gradually over a period of weeks rather than right away. Individual results vary and are not guaranteed. A licensed provider can talk through what may be reasonable to expect in your situation, and this information is educational rather than medical advice.

HCT/Ps — human cells, tissues, and cellular and tissue-based products — are defined in 21 CFR 1271.3(d) as articles containing or consisting of human cells or tissues intended for implantation, transplantation, infusion, or transfer into a human recipient.

Section 361 of the Public Health Service Act governs HCT/Ps that meet all four criteria in 21 CFR 1271.10(a). Under the FDA's tiered, risk-based approach, products meeting these criteria do not require premarket review or approval to be marketed — but they are not "FDA-approved." They are regulated solely under Section 361 and 21 CFR Part 1271, and the manufacturer must register and list with the FDA. The products we use are FDA-registered, not FDA-approved.

Section 351 governs biological products that do not meet the criteria to be regulated solely under Section 361. Section 351 products are handled like drugs or devices — they need an Investigational New Drug (IND) in effect or premarket approval before they can be marketed. Section 361 products that retain their primary structural function and are used homologously are considered a known quantity and do not require an IND or premarket approval.

Under 21 CFR 1271.10(a), an HCT/P is regulated solely under Section 361 if it meets all four criteria: it is (1) minimally manipulated; (2) intended for homologous use only, as reflected in labeling and advertising; (3) not combined with another article, except water, crystalloids, or a sterilizing/preserving/storage agent; and (4) does not have a systemic effect and is not dependent on the metabolic activity of living cells for its primary function (with limited exceptions for autologous, first/second-degree relative, or reproductive use). Manufacturers meeting these criteria must register and list their products with the FDA.

As defined in 21 CFR 1271.3(c), 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 function in the recipient as in the donor. In the donor, Wharton's jelly cushions and supports; in the recipient, it does the same basic structural job.

No. An HCT/P can perform the same basic function even when it isn't used in the same anatomic location as in the donor. It may replace, repair, reconstruct, or supplement missing or damaged tissue in a different location, as long as it performs the same basic function in the recipient as in the donor.

For structural tissue, minimal manipulation means processing that does not alter the original relevant characteristics of the tissue relating to its utility for reconstruction, repair, or replacement. (For cells or nonstructural tissues, it means processing that doesn't alter their relevant biological characteristics.) The products we use are processed to preserve that structural integrity.

Yes. If a product doesn't have objective evidence that the tissue still performs the same basic function as in the donor, the FDA assumes it does not meet the minimal-manipulation criterion — which is why manufacturers maintain studies and data demonstrating that the structural characteristics are preserved after processing.

Yes. Homologous use depends on the function of that tissue in the donor. For example, amniotic membrane's basic function is to serve as a covering or barrier, while Wharton's jelly's is to cushion and structurally support. After processing, the product must retain its original relevant characteristics to perform the same basic function in the recipient.

Yes. The FDA's July 2020 guidance gives detailed examples of homologous vs. non-homologous use and of minimal vs. more-than-minimal manipulation across tissue types (bone, skin, amniotic membrane, adipose, and others), to help determine whether a product can be regulated under Section 361.

The FDA describes amniotic membrane's basic function as acting as a barrier. When it's processed into a liquid, it can no longer serve as a barrier, so that processing is considered more than minimal manipulation. Wharton's jelly's basic function is cushioning and support — a function it can retain when processed into a flowable form — so it can still meet the minimal-manipulation criterion.

An RFD is a formal request asking the FDA to classify a product or assign the agency center responsible for it. It isn't needed for every product — it's used when a product's classification is unclear or in dispute, and is generally submitted before any investigational or marketing application.

Generally no. Products under an Investigational New Drug application can't be sold commercially because there isn't yet sufficient evidence of safety and efficacy for a specific disease or condition. Commercial sale follows once enough data establishes an approved product.

Yes. The registered tissue banks we partner with provide physician-facing training drawn directly from 21 CFR Part 1271, and our licensed providers are trained on appropriate handling and application.

The relevant materials are public: the FDA's tissue guidances (fda.gov), the 2001 establishment registration and listing rule (federalregister.gov), and the regulations at 21 CFR Part 1271 (accessdata.fda.gov). We're happy to point you to them.

The FDA maintains a public database of registered tissue establishments and products — the Human Cell and Tissue Establishment Registration (HCTERS) — searchable by product or company name at FDA.gov.