Stem Cell Therapy in Philadelphia

There are currently no FDA-approved perinatal-derived tissue products for orthopedic or wellness applications.
However, the products we use are regulated by the FDA under Section 361 of the Public Health Service Act (21 CFR 1271). This means they must meet strict standards for:

• Donor eligibility screening and testing
• Tissue processing and handling
• Sterility and storage
• FDA registration and product listing by name

The FDA inspects Vitti Labs multiple times throughout the year to ensure ongoing compliance with safety and manufacturing requirements.

This is a great question and is often misunderstood. In the United States, products used in what are commonly referred to as “stem cell therapies” are generally regulated by the FDA as drugs under the 351 pathway.

Under this pathway, these products require clinical trials and FDA approval before they can be marketed or offered outside of an approved clinical trial. However, there is a separate and well-established regulatory pathway, known as the 361 pathway, which allows for the use of certain human tissue products in medical practice today, including perinatal tissues.

These 361-regulated products include those sourced from umbilical cord and related birth tissues. They contain both structural and cellular components naturally present in these tissues, including stem cells, and are regulated based on their role in supporting the body’s tissue environment.

When handled in accordance with FDA Section 361 guidelines, they can be used legally by physicians without going through the drug approval process.

Some patients consider traveling abroad for stem cell treatments, often due to broader claims made by international clinics. However, it’s important to understand that regulatory standards vary significantly between countries.
In the United States, tissue products are regulated under a defined FDA framework with requirements for:

• Donor screening and testing
• Processing and handling standards
• Sterility and traceability

In some international settings, these standards may differ, and patients may have less visibility into sourcing, quality control, and safety protocols. There have also been reported cases of serious complications, including infections, following procedures performed in less regulated environments, underscoring the importance of careful evaluation when considering treatment abroad.

At Meeting Point Health, our focus is to provide care within a regulated medical environment, where patient safety and oversight are prioritized. Using regulated U.S tissue products, patients can receive a similarly comprehensive treatment approach that can be administered incrementally and monitored over time.

At Meeting Point Health, we carefully select our laboratory partners based on quality, safety standards, and regulatory compliance.

Vitti Labs is AATB-accredited, cGMP-certified, and registered with the FDA, so all products undergo regular inspections to meet strict compliance standards in accordance with 21 CFR 1271.

Key factors that influenced our stem cell product decisions include:

• Rigorous donor screening and testing protocols
• Closed-system manufacturing for quality control
• Independent laboratory testing of 20% of product to prioritize safety
• An established track record working with physicians nationwide
• A broad range of products to serve a variety of patient concerns
• A patented manufacturing process designed to preserve the integrity of the components

The tissue is ethically obtained through voluntary donation from healthy mothers undergoing planned, full-term cesarean deliveries resulting in a healthy baby.

Donors are carefully screened and tested prior to and on the day of delivery, and the tissue is recovered and processed under strict medical and regulatory protocols.

Injection-based procedures may involve mild discomfort at the site, similar in nature to other therapeutic injections. IV and nebulized delivery methods are generally well-tolerated. Our clinical team prioritizes your comfort throughout the entire treatment process and is available to address any concerns before, during, and after your appointment.

Perinatal tissue allografts contain a combination of:

• Structural components (such as collagen, hyaluronic acid, and elastin)
• Signaling components (including MSCs, growth factors, and extracellular vesicles)

These components work together to support the body’s natural repair processes, particularly in areas of injury or degeneration.