NEPA Vital Signs - Winter 2019 Spring 2020 - 15

WINTER 2019-2020

illions of patients suffer daily from
terminal or chronic diseases and
they search optimistically for a
cure. Fueled by the internet, the world
promises new and effective treatments,
which are almost without exception,
expensive and not covered by health
insurance. Frequently, treatments are
unavailable in the United States due to
regulatory oversight of the Food and
Drug Administration (FDA) or another
governmental agency. Not to be denied,
the patient desperately arranges to receive
treatment overseas. Taking for granted the
safety provided by FDA regulation, the
patient travels abroad - so-called medical
tourism - and receives their potentially
life-saving treatment. Alternatively, a local
healthcare provider deceptively markets
services for similar treatments making
unrealistic promises to the same desperate
patients frustrated by their pain or poor
health. Hopefully, the promise of a cure
is met. But all potential rewards have
attendant risks. The treatment results
can be disappointing. Potentially, tens
of thousands of dollars are lost for an
unproven or unsafe treatment performed
by unscrupulous providers. Or worse,
the treatment results in a catastrophic
outcome, as recently reported in the
national media. One of these treatments
especially at risk for this abuse is regenerative medicine.

Millions of dollars each year are spent
on topical formulations and procedures to
prevent or reverse the ravages of aging.
Yet a major factor that contributes to the
aging process is ultraviolet light exposure.
taking life-long medications, including
opiates and anti-inflammatory medications with their obvious unintended
consequences and risks, orthobiologics
offer great hope for a cure.

the person in whom they are being used.
This use of one's own body tissues or cells
is called autologous. There are reasons a
patient or their physician may wish to use
someone else's tissue or cells. This use of
another person's cells is called allograft
or allogeneic use. The other human's tissues used are immunoprivileged meaning
they will not result in rejection, such as
happens with certain organ transplants.
Other autologous and allogeneic tissues
being applied in the clinical setting include
exosomes, alpha2macroglobulin, IRAP,
and platelet lysate. The physician must
be knowledgeable regarding the pros
and cons of these different regenerative
medicine options.

Currently, the evidence-basis for these
treatments is quite limited and as a result,
the FDA has had to restate its position.
The FDA has closed some medical clinics
and warned others regarding the inapproRegenerative medicine is a branch of priate marketing or use of regenerative
medical science which deals with the medicine therapies.
process of replacing, engineering, or
regenerating human cells, tissues or
Nevertheless, basic and clinical research
organs to restore or establish normal studies continue internationally. The usefunction. Regenerative medicine uses fulness of Bone Marrow Aspirate (BMAC),
human blood or one of its components which are stem cells obtained usually from
such as platelets also referred to as ortho- the own patient's hip, is being studied
Physicians have all taken the oath, "First
biologics. Other orthobiologics include in the treatment of conditions such as do no harm." We have reached a crossmesenchymal (NOT embryonic) stem internal disc disruption (degenerative roads. Regenerative medicine has opened
cells, which are extracted painlessly from disc disease), knee osteoarthritis, rotator a panacea of potentially life-changing
the hip bone marrow at bedside. In mus- cuff tears, and many other maladies. One therapies which when applied properly
culoskeletal medicine, also referred to as of the great benefits of orthobiologics is should be without significant risk. However,
sports, orthopedic or pain medicine, the that they are natural, coming directly from buyer beware.
use of orthobiologics for the treatment
of chronic pain associated with arthritis,
SCOTT NAFTULIN, D.O., is a physiatrist at Northeastern Rehabilitation Associates and
degenerative disc disease or other spine
has been with the practice since 1998. He is board certified by the American Board of Physical
Medicine and Rehabilitation with a Sub-specialty in Pain Medicine, American Osteopathic Board
and joint disorders has become an alterof Physical Medicine and Rehabilitation, American Osteopathic Board of Family Practice and the
native for which there is great fervor by
American Board of Independent Medical Examiners.
patients and physicians alike. Instead of
N E PA

VITAL SIGNS

NEPA Vital Signs - Winter 2019 Spring 2020

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