Regenerative medicine involves therapies that repair, restore, or regenerate damaged tissues, offering a major leap beyond traditional treatments that merely mask symptoms. These therapies fall into two categories: those using a patient’s own biologics (like bone marrow or adipose tissue) and those from external sources (such as PRP therapy, amniotic fluid/membrane, or umbilical cord blood/tissue). Misinformation about external-source biologics is common, often spread by industry competitors using skewed data to mislead potential patients.

Amniotic and umbilical cord tissues are sourced from healthy, consenting donors under 35 during planned C-sections, with the process tightly regulated by the FDA to ensure safety through rigorous acquisition, testing, processing, and storage standards.

During a routine C-section, products of conception—such as amniotic fluid, placenta, and umbilical cord—are typically discarded. Instead, with the mother’s consent and the baby unharmed, these materials are donated, placed in a sterile container, and promptly delivered to a nearby FDA-registered, certified lab.

No, biologic materials do not come from “aborted fetuses.” During collection, babies are unharmed, and the donated materials, typically discarded, are used instead.

Additionally, embryonic stem cells are no longer legally used in the US. There’s no fetal tissue or cloning involved, and all donors are thoroughly screened and provide consent per FDA regulations.

This ensures there are no ethical concerns with using these products of conception.

Referred to as “products of conception,” regenerative materials from amniotic and umbilical tissues include:

1. Amniotic Fluid
2. Umbilical Cord Tissue
3. Umbilical Cord Blood
4. Wharton’s Jelly

While their precise role in fetal development is beyond this guide’s scope, these materials support fetal growth and translate to patient benefits in regenerative procedures, such as preventing infection and promoting tissue growth (e.g., collagen, tendon, lung, kidney, heart).

Research highlights several benefits of these materials, including:

• High stem cell counts
• Abundant growth factors
• Numerous cytokines
• Other components like exosomes, microsomes, secretomes, and mRNA

A fitting analogy is that these materials form a regenerative “orchestra,” delivering a comprehensive array of components for patient treatment.

Note: Some competitor marketing may claim “products of conception” lack live cells. This can be true if biologics are heavily radiated or over-preserved during processing, but not if processed with minimal radiation and preservatives. This is why MDVISIT CLINIC carefully selects labs to ensure safe, high-quality products for optimal patient outcomes.

The range of conditions that may benefit from amniotic and umbilical procedures is broad and expanding. Under FDA regulations, these biologics can be used for conditions where physicians consider them safe and clinically appropriate. Our disclaimer remains: None of the therapies mentioned have been evaluated by the FDA. As with all medical procedures, MDVISIT CLINIC does not guarantee specific outcomes, and no protocol or biologic indication has been evaluated or approved by the FDA.

• Sports Injuries
• Neurologic Conditions:
• Soft Tissue Conditions: Tendonitis, Bursitis, Ligament Injury (e.g. Achilles, Knee, Rotator Cuff)
• Arthritis: All Types
• Autism
• Migraines and Cluster Headaches
• Post Herpetic Neuralgia
• Diabetes
• Pelvic Pain
• Phantom Limb Pain
• Lyme Disease
• Fibromyalgia
• Heart/Kidney/Lung Failure (e.g. Cardiomyopathy, COPD)
• Back Pain
• Cerebral Palsy
• Trigeminal Neuralgia
• SI Joint Pain
• Erectile Dysfunction
• RSD
• Tennis/Golfer’s Elbow
• Neuropathy
• Plantar Fasciitis

PRP, or platelet-rich plasma, is derived from a patient’s blood draw, placed in a kit, and spun in a centrifuge for 10-15 minutes. This separates the blood into layers, with the middle “buffy coat” layer containing concentrated platelets, white blood cells, and 8-12 growth factors. PRP has minimal, if any, stem cells, making it a valuable regenerative biologic but not a stem cell therapy.

In contrast, amniotic and umbilical cord materials contain over 80 growth factors, along with abundant cytokines, mRNA, exosomes, secretomes, and other elements, including stem cells. The concentration of these components varies by lab, depending on factors like preservatives or radiation used in processing.

No Harvest Required

Bone marrow stem cell procedures involve aspiration from the patient’s iliac crest (pelvis), which carries a 29% risk of chronic pain and potential complications like nerve or vessel injury, bowel perforation, or fracture. Additionally, stem cell quantity and quality in bone marrow decline sharply with age—1 in 10,000 cells at birth versus 1 in 2 million by age 70. Amplifying cell counts through culturing is illegal in the US, and concentrating bone marrow doesn’t solve the low cell count issue.

Adipose-derived stem cell procedures require mini-liposuction from the abdomen or buttock, but many patients lack sufficient fat tissue. While adipose tissue is rich in stem cells, over 80% die within 48 hours after processing and transfer, limiting their effectiveness.

Safety

Bone marrow aspirations have a high complication rate, with 29% of patients experiencing chronic pain—ironic when the goal is pain relief. Other risks include infection, bleeding, nerve/vessel damage, bowel perforation, and pelvic fracture. Mini-liposuction for adipose procedures has fewer complications, but the rapid stem cell die-off undermines its value.

Amniotic and umbilical materials bypass these issues entirely by eliminating the need for invasive harvesting. Amniotic fluid lacks sufficient HLA (MHC) factors to trigger rejection, making it immunologically privileged and safe from Graft-versus-Host reactions. Umbilical cord tissue or blood could potentially cause rejection if not processed correctly, but removing red blood cells eliminates HLA factors, preventing adverse reactions.

Consistency

Amniotic and umbilical materials offer high consistency when processed at FDA-certified labs, delivering robust and reliable cell counts. Unlike bone marrow and adipose, where cell numbers and quality drop significantly with age, these materials maintain their potency. A common myth claims processed amniotic fluid lacks live cells. However, the FDA doesn’t mandate radiation, and with minimal preservatives, cells remain viable. Cryopreservation also preserves cell vitality (as seen in egg donor programs), ensuring labs using careful methods deliver abundant live cells.

Excellent Outcomes

Countless studies demonstrate the effectiveness of amniotic and umbilical tissues for musculoskeletal conditions—PubMed is a great resource, with key references listed at this guide’s end. With a high benefit profile and minimal risk, these therapies are a medical “home run.”

No, amniotic and umbilical materials are not regulated as drugs; they are classified as biologics. While heavily overseen by the FDA, they are not subject to an approval or denial process. Here’s how the FDA categorizes regulation:

• Medical Devices: Includes joint implants, screws/rods, durable medical equipment, etc. In regenerative medicine, this covers kits used for PRP, bone marrow, or adipose procedures.
• Drugs: Medications like Lipitor, Vicodin, or Viagra, which undergo clinical trials and receive FDA approval for specific uses.
• Biologics: Governed under CFR Part 1271, this category includes strict FDA rules on how biologic materials are acquired, processed, stored, and used. Amniotic and umbilical materials fall here, bypassing the approval/denial process required for drugs.

Specifically, these tissues are regulated as Section 361 products under Part 1271, requiring no FDA licensing or approval, per Section 361 of the Public Health Service (PHS) Act.

Dr. Arnold Caplan, a pioneer at Case Western Reserve University, is considered the father of modern stem cell therapy. His research reveals that regenerative materials primarily act as signals, prompting the body to “start working” and repair itself. He suggests redefining MSCs—typically Mesenchymal Stem Cells—as Medicinal Signaling Cells.

This shift “better reflects how these cells target sites of injury or disease, releasing bioactive factors that modulate the immune system and promote regeneration, essentially producing therapeutic drugs on-site.” He adds, “It’s the patient’s own local, tissue-specific stem cells that build new tissue, driven by the bioactive factors from the externally provided MSCs.”

MDVISIT CLINIC is growing clinics across the country offering regenerative procedures. If your nearest center doesn’t provide the specific treatment you need, our concierge service can help arrange travel to a center that does.

Regenerative procedures are not currently covered by insurance, but this isn’t because they’re ineffective. Insurance coverage is complex, even for FDA-approved drugs, and amniotic fluid or umbilical cord tissue can’t be patented by pharmaceutical companies.

New technologies often take 5-10 years to gain acceptance for coverage by commercial insurers and Medicare. A positive step is that some states now cover these procedures under Worker’s Compensation claims, as they help patients return to work.

MDVISIT CLINIC ensures finances don’t block access to regenerative therapies, offering various financing options and payment plans.

Substantial research on products of conception has been published in peer-reviewed journals or presented at national professional society meetings. New studies are added monthly, consistently demonstrating the safety of amniotic and umbilical materials.

These materials have also shown promising results for a range of conditions, including musculoskeletal disorders, neurodegenerative diseases, autism, stroke, organ failure, autoimmune conditions, and challenging cases like Lyme disease.

It’s inappropriate for anyone to set unrealistic expectations about these therapies. Terms like “heal” or “cure” are misleading and erode patient trust. No study shows 100% success, and while patients often experience improvement and relief, a “cure” is not guaranteed. When asked if our affiliated providers offer a “guarantee,” the answer is no—medical procedures are never certain. More accurate terms include facilitate, mitigate, or improve.

The biologic components in these materials collaborate to repair damaged tissue and support the body’s own repair processes. The degree of improvement varies because each person is unique.