Evaluation of Outcomes With Amniotic Fluid for Musculoskeletal Conditions Musculoskeletal Conditions

Medical providers are often faced with patients whose source of pain may be the result of an
inflammatory response caused by trauma or disease. By managing the patient's inflammation,
the clinician may see improved response to traditional pain management therapy and existing
protocols.

Also, degenerative arthritis of spinal and extremity joints may lead to significant low back,
knee, hip, shoulder pain etc, as the ratio of cartilage degradation to cartilage formation
increases with age. An amniotic tissue derived product may prove to be an ideal non-steroidal
and potentially regenerative therapy for use by the medical provider due to its unique
characteristics.

The orthopedic application of amniotic fluid dates back to at least the 1930's. The placental
membranes produce an array of immunosuppressive and anti-inflammatory molecules, which make
these tissues suitable for use as a wound covering [or as an anti-inflammatory] in a clinical
setting. In addition to structural properties, placental membrane and amniotic fluid (AF) is
a rich source of growth factors, including organic compounds and nutrients, hyaluronic acids,
amino acids, antioxidants and stem cells.

AF's anti-inflammatory actions may be mediated in part by its secretion of anti-inflammatory
cytokines including interleukin-10, inhibin, activin, and interleukin-1 receptor antagonist
as well as anti-inflammatory protease inhibitors such as ∞-1 anti-trypsin inhibitor and
inter-a-trypsin inhibitor. AF may modulate acquired immunity by suppressing alloreactive
responses and down regulating production of Th1 and Th2 cytokines.

In addition to having known anti-inflammatory qualities, placental membrane cells, derived
from the layer of trophoblast cells covering the developing embryo, do not express MHC Class
II antigens, which are responsible for the rapid rejection of allografts in humans. Because
AF is immune privileged, it is an ideal allograft with no known graft-versus-host disease
(GVHD).

The amniotic fluid product may provide not only an anti-inflammatory response, but also
potentially yield regenerative effect or reduce further cartilage degeneration.

The objective of this study is to evaluate an amniotic fluid tissue product in the treatment
of pain due to all types of musculoskeletal conditions.

Inclusion Criteria:

1. Age 18 and over.

2. Ability to attend follow up visits or at least converse on phone or complete email
follow up forms.

4) Competent to understand the study protocol and provide voluntary informed consent.

Exclusion Criteria:

1. Active Infection

2. Pregnancy, Lactating

3. Clotting disorder