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
Condition: Knee Osteoarthritis; Knee Pain Chronic; Joint Disease; Arthritis; Osteo Arthritis Knee; Musculoskeletal Disease
MeSH terms: Arthritis; Osteoarthritis; Osteoarthritis, Knee; Joint Diseases; Musculoskeletal Diseases
Study type: Interventional

Summary: 
      The purpose of this study is to compare the pain, functioning and pain medication consumption
      of knee osteoarthritis (OA) patients who have allogenic cytokines derived from human amniotic
      membranes (HAM) and allogenic mesenchymal stem cells derived from human umbilical cord
      Wharton's Jelly (HUMCWJ) implanted into the affected knee with knee OA patients who
      self-select to be in a non-intervention control group.
    

Detailed description: 
      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.
    

Intervention name(s): HAM and HUMCWJ Injections
Intervention type(s): Procedure
Intervention description(s): SURGENEX SurForce® (1cc) allograft placental based tissue matrix, will be injected using a 22 gauge, 2-inch needle. The injection site (medial, lateral, patellar) will be determined based on the side with the most joint space from the findings of the most recent x-rays. The Physician will insert the needle fully into the joint space and begin to expel the fluid. He will achieve a continuous injection flow as he withdraws the needle back out of joint space. Immediately following the SURGENEX SurForce® injection, an injection of Predictive Biotech CORECYTE(TM) (1 cc) allograft umbilical cord-derived Warton's Jelly tissue matrix will be administered. This will be done using the exact same protocol as the SURGENEX SurForce® injection.
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Stem Cell Injection; Cytokine; Wharton's Jelly; Stem Cells