Regenerative Medicine and Therapies in orthopedics is an area of great interest for patients and doctors alike. When you visit Dr. Stolarski’s office and meet with him or one of his three physician assistants, James, Jackie, or Brooke, no doubt your goal is reducing pain, improving function, and restoring your quality of life. Patients for whom surgery is not indicated, often have success managing their arthritis symptoms with conservative measures such as physical therapy and bracing, or medications such as nonsteroidal anti-inflammatories, or joint injections of cortisone or “gel” products (hyaluronic acid/viscosupplementation). However, these products do not have a regenerative or disease modifying effects on osteoarthritis. For all intensive purposes though these products function as band aids.

In the realm of regenerative medicine, certain tissues in the body are known to be rich in substances that can be beneficial in the healing process, in reducing scar tissue, or reducing or modulating inflammation. These substances are called growth factors, cytokines (pronounced sigh-to-kines), and enzyme inhibitors. Growth factors are substances in the body, often proteins or hormones, associated with stimulating cellular growth, proliferation, and healing. Cytokines are a large category of small proteins involved in cell signaling. Enzyme inhibitors are small molecules that bind to enzymes in the body and slow down their activity.

Amniotic tissues have been used in modern medicine over the course of the last century in wound care, for burn victims, in eye procedures, and orthopedics. While there are a myriad of these growth factors, several specific ones have been identified to enhance healing and modulate inflammation. These are:

  • Transforming Growth Factor Beta is believed to promote the healing of soft tissue and reduce scar formation
  • Fibroblast Growth Factor has been shown to enhance tissue repair and promote cellular proliferation and collagen matrix formation
  • Platelet-Derived Growth Factor (PDGF) has been shown to promote cellular proliferation in connective tissue and enhance soft tissue healing. Laboratory cultured PDGF is used to aide in the healing of chronic ulcers and in orthopedic surgery and periodontics its used to stimulate bone regeneration and repair

Another very promising component of amniotic membrane that has been shown suppress inflammation and scarring is Heavy Chain-Hyaluronic Acid/Pentraxin 3 (HC-HA/PTX3). The HC-HA/PTX3 found in amniotic tissue products is a substance being studied in a variety of medical indication throughout the body for its potent properties.

Dr. Stolarski is an advocate of the use of amniotic tissue products both in clinic at Kennedy-White Orthopaedic Center and in the operating room. These are products that have been careful prepared using elements from the placenta and/or umbilical cord. All amniotic tissue products available through Dr. Stolarski’s practice have their origin in elective, caesarian section (c-section) births in the US. Donor mothers are carefully screened for communicable diseases as part of the voluntary donation program.

Donated tissue is processed in accordance with the GTP (Good Tissue Practices) and the requirements of the US Food & Drug Administration (FDA) as well as the American Association of Tissue Banks (AATB).

These donated tissues have three possible layers/sections that are used in regenerative medicine. These layers are:

  • the amnion, the innermost membrane of the placenta closest to the developing baby (the fetus)
  • the chorion (pronounced core-ee-on), the outermost membrane of the placenta closest to the mother
  • the umbilical cord, the conduit between the developing baby and the placenta

For patients that receive these products as an intra-articular joint injection, our hope is that patients will see a reduction of their symptoms and an improvement in their quality of life. For patients having these products injected after a total knee or total hip replacement procedure in the hospital, the goal of the injection is to aid in the healing of the soft tissue around the joint and the new prosthetic, as well as to aide in the reduction of scar tissue and inflammation.

The ongoing research being conducted in the US, together with the research on the immediate horizon, will tell us the exact percentages of the research patients in those trials that reported reduction in pain or improvement in other measures compared to placebo. These large, prospective, randomized, multi-center studies will provide us with exact data points. Until their completion, we are relying on our own anecdotal observations in Dr. Stolarski’s practice together with the smaller studies that have been completed to date. Below is a list of some of the pertinent research that has been completed to date.

Title Date # of Patients Anatomical Location Researchers Location
Safety Analysis of
Cryopreserved
Amniotic Membrane/Umbilical Cord Tissue
in Foot and Ankle Surgery: A Consecutive
Case Series of 124 Patients
2014 124 Foot & Ankle Westerville, Ohio
The Use of Amniotic
Membrane/Umbilical Cord in First
Metatarsophalangeal Joint Cheilectomy:
A Comparative Bilateral Case Study
2014 Case Report (1 patient) Foot Charlotte, North Carolina
An Open-label,
Single-center, Retrospective
Study of Cryopreserved Amniotic
Membrane and Umbilical Cord Tissue
as an Adjunct for Foot and Ankle Surgery
2014 14 Foot & Ankle Baton Rouge, New Orleans,
Louisiana
Cryopreserved Human
Amniotic
Membrane Injection for Plantar Fasciitis:
A Randomized, Controlled, Double-Blind
Pilot Study
2015 14 Foot (Plantar Fasciitis) Morgantown, West Virginia
A Retrospective Study of
Cryopreserved Umbilical Cord as an Adjunctive Therapy to
Promote the Healing of Chronic, Complex Foot Ulcers with Underlying
Osteomyelitis
2016 31 Complex Ulcers with
Osteomyelitis
Belleville, New Jersey
The Use of Cryo-Preserved
Umbilical Cord Plus Amniotic Membrane Tissues in the Resection of
Tarsal Coalition
2016 14 Hindfoot Charlotte, North Carolina
Plantar Fasciitis Treatment
With Particulate Human Amniotic Membrane
2016 18 Foot (Plantar Fasciitis) Oak Lawn, Illinois
A single-center,
retrospective study
of cryopreserved umbilical
cord/amniotic membrane tissue
for the treatment of diabetic foot ulcers
2016 29 Foot (Diabetic Foot Ulcers) Smyrna, Georgia
Patient-Reported Outcomes
and Return
to Activity After Peroneus Brevis Repair
2016 201 Foot Ohio, Colorado
Cryopreserved Amniotic
Membrane Improves Clinical
Outcomes Following Microdiscectomy
2017 80 Spine Philadelphia, Pennsylvania
Effects of Cryopreserved
Amniotic Membrane Allograft on Total Ankle Arthroplasty Wound Healing
2017 multiple, undisclosed Ankle Charlotte, North Carolina
Use of cryopreserved
umbilical cord with negative pressure wound therapy for complex ulcers with
osteomyelitis
2017 13 Complex Ulcers with
Osteomyelitis
Smyrna, Georgia
Amniotic Membrane and
Umbilical Cord Particulate for Pain Associated with Knee Osteoarthritis:
Preliminary Results of a Single-center, Prospective, Pilot Study
2018 20 Knee Miami, Florida