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

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 shoulder. Follow-up will consist of a larger sample including 4,000
patients.

Patients will be treated for Osteoarthritis (OA) of the shoulder 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 the
RegenLab (RegenKit BCT-3) PRP product each as direct injections to the affected joints.
Patient outcomes will be tracked with laboratory tests for inflammation markers, the DASH and
SPADI questionnaires and a follow up MRI at various endpoints to 6 months. SF-36 forms (a
quality of life measure) and numerical ratings 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 shoulder planning/replacement therapy.

Inclusion Criteria:

1. Patients with indication of Osteoarthritis. 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 shoulder pain with the index side (left or right shoulder).

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

2. Corticosteroid injection at treatment site within 1 month

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