Effect of Implanting Allogenic Cytokines Derived From Human Amniotic Membrane (HAM) and Mesenchymal Stem Cells Derived From Human Umbilical Cord Wharton's Jelly (HUMCWJ) on Pain and Functioning of Knee Osteoarthritis

A total of 60 patients will be recruited from Scott Medical Health Center in Pittsburgh, PA.
Inclusion criteria for the study are knee OA patients who are eligible for HAM and HUMCWJ
therapy of their knee, no previous HAM or HUMCWJ therapy, between the ages of 50-85,
independently residing in the community, no previously diagnosed cognitive decline or mental
illness, and not taking pain medication more than once per week for a condition other than
knee OA. Recruitment will be done in two parts as participants will self-select to
participate in one of two study groups. All participants who elect to have the procedure done
at the initial consultation, meet inclusion criteria, and agree to be in the study will be
placed in Group 1. Participants who do not wish to have the procedure, meet inclusion and
exclusion criteria, and agree to be in the study will be placed in Group 2. Those
participants who are unsure about the procedure and need more time to decide will be
contacted 2 weeks later and then group will be determined by their decision. All participants
will be required to sign a written informed consent prior to data collection. Following
written consent, all participants will undergo data collection (T0). At T0, participants will
complete a demographic and medication use questionnaire, the Western Ontario and McMaster
Universities Arthritis Index (WOMAC), knee survey, and be timed during a single trial of
three functional tasks. Participants will also provide a pain rating while completing each of
the functional tasks. Group 1 will then undergo HAMS injection to the OA affected knee
immediately following the testing battery. Group 2 will delay the HAMS injection to the OA
affected knee for at least 3 months or never receive the injection. All participants will
complete T1 data collection approximately 4 weeks following completion of T0 data collection
and T2 data collection approximately 3 months following completion of T0 data collection. The
T1 and T2 data collections will use the same data collection procedures and questionnaires.

Inclusion Criteria:

- knee OA patients who are eligible for HAM and HUMCWJ therapy of their knee, no
previous HAM or HUMCWJ therapy, between the ages of 50-85, independently residing in
the community, no previously diagnosed cognitive decline or mental illness, and not
taking pain medication more than once per week for a condition other than knee OA

Exclusion Criteria:

- Allergy to or use of penicillin, streptomycin, emphotericin B or dimethylsulfoxide.
DMSO allergies and any immunocompromised conditions will also be excluded