Regenerative healing starts here

Amniotic and umbilical cord tissues are ethically sourced from healthy, consenting donors under the age of 35 who are undergoing scheduled cesarean sections. The entire process—from tissue collection to testing, processing, and storage—is strictly regulated by the FDA to ensure optimal patient safety.

Typically, during a routine scheduled C-section, materials such as the amniotic fluid, placenta, and umbilical cord—collectively known as products of conception—are discarded. In this case, however, the mother voluntarily donates these materials, and both she and the baby remain healthy and unaffected. The donated tissues are immediately placed in sterile containers and transported to a nearby FDA-registered and certified laboratory for further handling

The short answer is no—they are not all the same. Although the donor biologic material is very similar, the way it is processed can differ significantly. All donors are thoroughly screened for infectious diseases and are under the age of 35. Additionally, DNA components are removed to minimize the risk of rejection, making the biologic material immunologically privileged.

The most notable differences arise during processing at FDA-certified laboratories. While the FDA enforces strict guidelines, there is still variation in how labs handle the material. For example, some laboratories may irradiate the biologic, which destroys all living cells. Others may use excessive preservatives, which can also eliminate cell viability instead of preserving it.

As a result, not all products are equal after processing. It is essential to receive treatment from an experienced provider who uses high-quality, thoroughly vetted materials. At MB Stem Cell, we rigorously evaluate all biologics used in our treatments—one of the many reasons over 10,000 patients have trusted our Centers over the past six years.

At this time, regenerative procedures are not covered by insurance. This is not due to a lack of effectiveness, but rather the complexity of insurance approval—even for FDA-approved treatments. Additionally, since amniotic fluid and umbilical cord tissue cannot be patented, pharmaceutical companies have limited incentive to push for coverage. It’s common for emerging medical technologies to take 5 to 10 years before gaining acceptance by commercial insurers and Medicare. That said, a promising development is that several states now recognize regenerative procedures as valid under Workers’ Compensation, especially because they’ve been effective in helping patients return to work.

At MB Stem Cell, we believe cost should not be a barrier to care. That’s why we offer multiple financing options and payment plans to make regenerative therapies more accessible.

It is important to set realistic expectations. Terms like “heal” or “cure” should be avoided, as they can mislead patients and erode trust. No therapy guarantees 100% success, and while many patients do experience meaningful improvement and relief, these treatments are not cures. We’re often asked if we offer guarantees, and the honest answer is no—because no medical procedure can promise perfect results. More appropriate terms include facilitate, mitigate, or enhance.

The biologic components used in these therapies are designed to support tissue repair and activate the body’s natural healing mechanisms. However, the extent of improvement varies from person to person—because each individual is unique.

No, these materials are not classified as drugs. Instead, they fall under the category of biologics, which are subject to strict FDA regulation. However, unlike drugs, biologics are not approved or denied through a traditional drug approval process.

Here’s how the FDA regulates different categories:

Medical Devices – Includes items like joint implants, surgical screws, rods, and durable medical equipment (DME). In regenerative medicine, this primarily applies to kits used for PRP, bone marrow, or adipose-derived procedures.

Drugs – Examples include medications such as Lipitor, Vicodin, or Viagra. These must undergo clinical trials and FDA approval for specific indications before being made available.

Biologics – The FDA tightly oversees how biologic materials are sourced, processed, stored, and used under Code of Federal Regulations (CFR) Part 1271. Amniotic and umbilical cord-derived products fall within this category. Importantly, biologics under this classification do not go through an approval or denial process like traditional drugs.

Specifically, these materials are considered Section 361 products, which means they are not required to be licensed or formally approved by the FDA. Instead, they are regulated under Section 361 of the Public Health Service (PHS) Act, focusing on safety standards to prevent the spread of communicable diseases.