Safety & Effectiveness of Autologous Regenerative Cell Therapy on Pain & Inflammation of Osteoarthritis of the Knee

This is a prospective open-label clinical study of 50 patients to determine safety and
treatment potential of autologous cell therapy for pain and inflammation associated with
Osteoarthritis of the knee. Follow-up will consist of a larger sample including 4,000
patients.

Patients will be treated for Osteoarthritis (OA) of the knee due to degeneration or chronic
injury. They will be treated with autologous Stromed obtained by the Adipose Ultrasonic Cell
Recovery Unit (AUCRU) and Platelet Rich Plasma (PRP) processed by RegenLab (RegenKit BCT-3)
PRP product each as direct injections to the affected joints.

Cohort 1 will include PRP treatments at time of initial StroMed treatment plus at 1 week, 2
weeks and 1 month.

Cohort 2 will include PRP treatments at time of initial StroMed treatment plus at 1 month and
2 months.

Patient outcomes will be tracked with a follow up MRI at various endpoints to 6 months,
laboratory tests for inflammation markers, and knee injury and osteoarthritis outcome score
(KOOS) questionnaires. SF-36 forms (a quality of life measure) and numerical rating scales
(NRS) will also be used to assess safety and efficacy of treatment, as well as any reduction
in patient medication and/or delay in pending knee replacement therapy.

Inclusion Criteria:

1. Patients with indication of Osteoarthritis, grade 2 or more. Can be from degeneration
or chronic injury.

2. Patients range from 18-90 years of age.

3. Patients must be able to comply with treatment plan, laboratory tests and periodic
interviews.

4. Patients with adequate renal function, Creatinine ≤ 1.5 mg/dl.

5. Patients with adequate cardiac and respiratory function.

6. Patients with adequate blood coagulation activity, PT(INR) < 1.5, APTT

7. Patients must have adequate immune system function, with no known immunodeficiency
disease.

8. Greater than 6 months knee pain on the index side (left or right knee).

Exclusion Criteria:

1. Neoplastic cancer within 5 years prior to screening, except for cutaneous basal cell
or squamous cell cancer resolved by excision

2. Presence of clinically significant acute or unstable cardiovascular and
cerebrovascular (stroke).

3. Diagnosis of a transient ischemic attack in the 6 months prior to screening.

4. Patients infected with hepatitis B, C or HIV.

5. Patients with Body Mass Index (BMI) > 40kg/m2

6. Presence of active infection.

7. Any other illness, psychiatric disorder, alcohol or chemical dependence that in the
opinion of the investigator would render a patient unsuitable to participate in the
study.

8. Conditions/therapies/factors which could confound or interfere with the evaluation of
pain/mobility including, but not limited to:

1. Knee instability.

2. A varus/valgus deformity of more than 10o, a deformity requiring osteotomy or
complex surgery.

3. Gout or pseudo gout

4. Treatments with strong opioid drugs in the previous 4 weeks for other pain rather
than knee osteoarthritis

5. Corticosteroid injection at treatment site within 1 month

6. Consistent use of NSAIDs within 48 hours of procedure.