Non-responders to conventional therapies should consider a stem cell approach before using long-term steroidal, non-steroidal treatments, and/or surgery.
At the Regenerative Center of Naples, the latest in cutting edge treatments such as amniotic stem cell injections may be used to successfully treat patients with degenerative arthritis, osteoarthritis, tendonitis, and more.
What Is Stem Cell Therapy?
Stem cell therapy is the use of healthy stem cells to prevent or treat a disease or a condition.
What Are Stem Cells?
Stem cells are the fundamental cells living in the human body. Their most amazing feature is that they can become many types of cell, from skin cells to muscle, from bone to cartilage. Today, stem cells are of great interest with clinical applications.
What Is Amniotic Stem Cell Injection?
or clarification, amniotic stem cells that we use are derived from the amniotic sac — not an embryo. While most people may have ethical concerns about embryonic stem cell therapy, most everyone agrees that the use of amniotic stem cell therapy raises no ethical or moral questions. Harvesting amniotic stem cells is a highly regulated procedure to help ensure the health and safety of the donors and recipients.
How Does Amniotic Stem Cell Therapy Work?
Stem cell treatment takes advantage of the body’s ability to repair itself. The amniotic stem cells can jump-start the healing process by creating the cells the damaged tissues need.
What Benefits Does Amniotic Stem Cell Treatment Offer?
- Amniotic stem cell therapy is very safe and effective.
- Amniotic stem cells rely on naturally occurring anti-inflammatory agents and contain NO STEROIDS.
- Amniotic stem cells help lubricate the cartilage since they contain hyaluronic acid (a natural lubricant of the joint)
- Amniotic stem cells contain growth factors which stimulate tissue growth.
- There is no risk of patient rejection with amniotic stem cells.
- Amniotic fluid is a highly concentrated source of stem cells. This makes it preferable over embryonic stem cells and the patient’s own stem cells (from fat or bone marrow).
Osteoarthritis, ligament, and tendon injuries are very common problems. Stem cell therapy for knee, feet, ankles, hips, elbows, wrist, hand, etc. is a non-surgical alternative for those who suffer from pain.
Surgeries can be painful and require an extended rehabilitation time. Regenerative medicine procedures such as stem cell therapy allow the body to heal itself by providing building blocks known as stem cells that stimulate the body’s natural healing processes to work.
Recent Data in Peer Reviewed Journals on the Use of Stem Cells
J Knee Surg. 2016 Aug;29(6):443-50.
Cryopreserved Amniotic Suspension for the Treatment of Knee Osteoarthritis.
There are few treatment options for symptomatic knee osteoarthritis (OA). Human amniotic suspension allografts (ASA) have anti-inflammatory and chondroregenerative potential and thus represent a promising treatment strategy. In anticipation of a large, placebo-controlled trial of intra-articular ASA for symptomatic knee OA, an open-label prospective feasibility study was performed. Six patients with Kellgren-Lawrence grades 3 and 4 tibiofemoral knee OA were administered a single intra-articular ASA injection containing cryopreserved particulated human amnion and amniotic fluid cells. Patients were followed for 12 months after treatment. No significant injection reactions were noted. Compared with baseline there were (1) no significant effect of the ASA injection on blood cell counts, lymphocyte subsets, or inflammatory markers and (2) a small, but statistically significant increase in serum IgG and IgE levels. Patient-reported outcomes including International Knee Documentation Committee, Knee Injury and Osteoarthritis Outcome, and Single Assessment Numeric Evaluation scores were collected throughout the study and evaluated for up to 12 months. Overall, this study demonstrates the feasibility of a single intra-articular injection of ASA for the treatment of knee OA and provides the foundation for a large placebo-controlled trial of intra-articular ASA for symptomatic knee OA.
Foot Ankle Int. 2015 Feb;36(2):151-8.
Cryopreserved human amniotic membrane injection for plantar fasciitis: a randomized, controlled, double-blind pilot study.
Treatment options for plantar fasciitis have resulted in varied patient outcomes. The aim of this study was to compare a novel treatment, cryopreserved human amniotic membrane (c-hAM), to a traditional treatment, corticosteroid. Our hypothesis was that c-hAM would be safe and comparable to corticosteroids for plantar fasciitis in regard to patient outcomes.
A randomized, controlled, double-blind, single-center pilot study was completed. Patients were randomized into one of 2 treatment groups: c-hAM or corticosteroid. Patients received an injection at their initial baseline visit with an option for a second injection at their first 6-week follow-up. Total follow-up was obtained for 12 weeks after the most recent injection. The primary outcome measurement was the Foot Health Status Questionnaire (FHSQ). The secondary outcome measurements were the Visual Analog Scale (VAS) and verbally reported percentage improvement. Data were analyzed between groups for the 2 different cohorts (1 injection versus 2 injections). Twenty-three patients had complete follow-up. Fourteen were randomized to receive corticosteroid and 9 were randomized to receive c-hAM.
Three patients in each group received second injections. With the numbers available, the majority of outcome measurements showed no statistical difference between groups. The corticosteroid did, however, have greater FHSQ shoe fit improvement (P = .0244) at 6 weeks, FHSQ general health improvement (P = .0132) at 6 weeks, and verbally reported improvement (P = .041) at 12 weeks in the one-injection cohort. Cryopreserved hAM had greater FHSQ foot pain improvement (P = .0113) at 18 weeks in the 2-injection cohort.
Cryopreserved hAM injection may be safe and comparable to corticosteroid injection for treatment of plantar fasciitis. This is a pilot study and requires further investigation.
LEVEL OF EVIDENCE: Level I, prospective randomized trial
Am J Sports Med. 2016 Sep;44(9):2425-34.
Human Amniotic Membrane-Derived Products in Sports Medicine: Basic Science, Early Results, and Potential Clinical Applications.
Amniotic membrane (AM)-derived products have been successfully used in ophthalmology, plastic surgery, and wound care, but little is known about their potential applications in orthopaedic sports medicine.
To provide an updated review of the basic science and preclinical and clinical data supporting the use of AM-derived products and to review their current applications in sports medicine.
A systematic search of the literature was conducted using the Medline, EMBASE, and Cochrane databases. The search term amniotic membrane was used alone and in conjunction with stem cell, orthopaedic, tissue engineering, scaffold, and sports medicine.
The search identified 6870 articles, 80 of which, after screening of the titles and abstracts, were considered relevant to this study. Fifty-five articles described the anatomy, basic science, and nonorthopaedic applications of AM-derived products. Twenty-five articles described preclinical and clinical trials of AM-derived products for orthopaedic sports medicine. Because the level of evidence obtained from this search was not adequate for systematic review or meta-analysis, a current concepts review on the anatomy, physiology, and clinical uses of AM-derived products is presented.
Amniotic membranes have many promising applications in sports medicine. They are a source of pluripotent cells, highly organized collagen, antifibrotic and anti-inflammatory cytokines, immunomodulators, and matrix proteins.
These properties may make it beneficial when applied as tissue engineering scaffolds, improving tissue organization in healing, and treatment of the arthritic joint. The current body of evidence in sports medicine is heavily biased toward in vitro and animal studies, with little to no human clinical data. Nonetheless, 14 companies or distributors offer commercial AM products. The preparation and formulation of these products alter their biological and mechanical properties, and a thorough understanding of these differences will help guide the use of AM-derived products in sports medicine research.
J Plast Reconstr Aesthet Surg. 2014 May;67(5):662-75.
The clinical applications of human amnion in plastic surgery.
Since the early 1900s, human amnion has been applied to a wide variety of clinical scenarios including burns, chronic ulcers, dural defects, intra-abdominal adhesions, peritoneal reconstruction, genital reconstruction, hip arthroplasty, tendon repair, nerve repair, microvascular reconstruction, corneal repair, intra-oral reconstruction and reconstruction of the nasal lining and tympanic membrane. Amnion epithelial and mesenchymal cells have been shown to contain a variety of regulatory mediators that result in the promotion of cellular proliferation, differentiation and epithelialisation and the inhibition of fibrosis, immune rejection, inflammation and bacterial invasion. The full repertoire of biological factors that these cells synthesise, store and release and the mechanisms by which these factors exert their beneficial effects are only now being fully appreciated. Although many commercially available biological and synthetic alternatives to amnion exist, ethical, religious, and financial constraints may limit the widespread utilisation of these products. Amnion is widely available, economical and is easy to manipulate, process and store. Although many clinical applications are of historical interest only, amnion offers an alternative source of multi-potent or pluripotent stem cells and therefore may yet have a great deal to offer the plastic surgery and regenerative medicine community. It is the purpose of this article to review the clinical applications of human amnion relevant to plastic surgery.