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12 Articles in this Series
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False-Positive Urine Drug Monitoring Results and Aspirin
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More Potential Uses for Low-Dose IV Naloxone
On the Horizon: A Brief Look at Potential Analgesics of the Future
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Stem Cells & Beyond
Underlying Causes of Small Fiber Neuropathies
Understanding Sexual Pain – A Physical Therapist’s Perspective
Video: Drs. Gudin & Fudin on PAINWeek 2018 and PPM's Future
Where Does the Patient-Centered Pain Practitioner Stand Today?
Why Interventional Tactics Should be Used for Chronic Pain Patients Now, Not Later

Stem Cells & Beyond

Considering the use of PRP, BMAC, or MSCs to treat chronic joint or inflammatory pain? In this PAINWeek 2018 highlight, Jay Joshi, MD, shares key considerations and tips for practitioners.

Practitioners earning CME Credits at PAINWeek 2018 in Las Vegas filled the session on “Stem Cells & Regenerative Medicine,” presented by Jay Joshi, MD, DABA, DABA-PM, FABA-PM, who serves as CEO and Medical Director of the National Pain Centers, and as a member of the PPM Editorial Advisory Board. An anesthesiologist involved in the field since 2012, Dr. Joshi set out to confirm what’s actually happening in regenerative medicine and its emerging use in chronic pain management. While many current developments are taking place in other countries, such as Israel, he noted, the United States research and healthcare community is catching up.

A Brief Overview

Regenerative medicine is most commonly used to treat inflammatory pain, whether peripheral or central. Stem cells and growth factor products—which are distinct from one another—represent branches of regenerative medicine, which deals with the process of replacing, repairing, and restoring normal tissue and function. Regenerative medicine may include, for instance, inflammatory reducing medications such as NSAIDs, steroids, synthetic hyaluronic acid, amniotic fluid liquid suspension, Wharton’s Jelly liquid suspension, and platelet rich plasma (PRP). The latter, PRP, has been around since 1987 and is often considered the first “real” type of regenerative medicine offered.

Dr. Joshi spent some time discussing PRP, of which the industry has differing views. While PRP can be beneficial, he said, it is not necessarily free from pathogens and other harmful products as the product is removed from and then reinjected into the patient. It also may result in side effects, such as increased pain/stiffness immediately after treatment. Thus, many questions still exist around the use of PRP, often leaving insurance payors and FDA to avert approval.

Regenerative cellular products may include lipoaspirate concentrate, bone marrow aspirate concentrate, umbilical cord blood, and mesenchymal stem cells (MSCs).

Stem cell research heightened throughout the 1960s-1980s, with the first stem cells extracted from human embryos in 1998. It’s important to clarify, Dr. Joshi noted, that today’s stem cell therapy does not use human embryos—a question many practitioners may get from their patients. Three major types of stem cells exist: totipotent, pluripotent, and multipotent. Current stem cell therapies are called homologous cell and tissue products (HCT/Ps) and are regulated through two FDA pathways, specifically, Sections 361 and 351 of the Title 21 Code of Federal Regulations. Non-autologous, allogenic products include umbilical cord-derived MSCs, umbilical cord tissue matrix, amniotic liquid suspension, and amniotic membrane.

The main advantage of autologous cells is their known source, but they do require a surgical procedure, which increases risks and costs. In addition, available concentrations of autologous cells may vary (eg, lipoaspirate 4,500 to 450,000 MSCs per CC; bone marrow aspirate concentrate, or BMAC, 30 to 300 MSCs per CC). Non-autologous cells, such as those that may exist from placentally derived tissue, offer high concentrations of MSCs, are epigenetically young, easily reproducible, do not require a surgical procedure, and typically do not cause an immunologic reaction. On the contrary, there is greater potential for bacterial or viral transmission and there can be logistical challenges (eg, some of the product must be shipped and stored at negative 200 degrees Celsius).

Stem Cell Use in Pain Management

Stem cell use in pain management is typically geared toward the treatment of non-resolving inflammation, such as that which stems from rheumatoid arthritis.  Patients with joint pain, specifically knee pain, are among the most common cases that Dr. Joshi sees in his regenerative medicine practice. Injections of adipose-derived adult MSCs are common but the process is not simple, he noted, sharing that it takes 60 CCs of adipose to obtain 1 CC with over 1 million cells.  BMAC, in comparison, produces a very dilute MSC, and requires a trocar through bone.

In terms of HCT/Ps, amniotic membrane, in particular, is now being more widely used in wound and surgical-scarring prevention treatments as it heals in a similar manner to new tissue rather than scar tissue. Morselized amniotic membrane and umbilical cord tissue allow for injection to the joints and other tissues for the facilitation of natural wound healing. For joint pain management, this growth factor product may help to reduce inflammation, prevent formation of new adhesions after closed manipulation, and more.

Overall, MSCs may differentiate into different cells or activate other stem cells at the sites of inflammation caused by tissue injury, unlike PRP, explained Dr. Joshi. They can also help to prevent inflammation and achieve immunomodulatory functions.

Stem cell storageStem cell storage

Considerations for Your Practice

If considering regenerative medicine, physicians and practices should be aware of the specific equipment needed on hand (eg, to count and determine flow cytometry; for marker identification [ie, red versus white cells]). These devices, while costly, are crucial.

In terms of acquiring product, Dr. Joshi admitted that finding a company, or companies, that are trustworthy, legitimate, and cost-effective, may take some trial and error. It is important to research a company’s science in-depth, he advised, and also to communicate openly with patients about which companies are used to secure product. Patient preference may be taken into account as well.

At the end of the day, regenerative medicine is growing—with more than 500 related articles published in 2017 alone, he cited. But challenges remain regarding FDA restrictions and insurance coverage, as well as variability in product (including counterfeits and false claims from companies and providers), and variability in physician training.


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