Adipose-Derived Stem Cell Injections for Knee Osteoarthritis

This study will be a randomized controlled trial to compare outcomes between intra-articular
injection of ADSC+PRP and intra-articular injection of corticosteroid in patients with mild
to moderate osteoarthritis of the knee. ADSC will be harvested at the subcutaneous tissue by
lipoaspiration. Once fat tissue is obtained, it will be processed with minimal manipulation
(Adiprep) in the clinic room.

PRP is prepped from the peripheral blood. Up to 30 ml of peripheral blood is drawn from the
peripheral blood vessel then it is transferred to the tube for centrifugation to yield a
platelet-rich plasma layer. This process is expected to take up to 1 hour.

To be considered for participation in this study, patients must have radiographic evidence of
mild to moderate osteoarthritis of medial and/or lateral weight-bearing compartments
(Kellgren-Lawrence Grade 2 or 3).

In addition, patients must meet several inclusion/exclusion criteria to be randomized and
included in this study.

Inclusion Criteria:

- Age between 35 and 75 years-old

- Diagnosis of pre-existing osteoarthritis of the joint by Kellgren-Lawrence Grade 2 or
3.

- Working understanding of the English language and able to fully understand the
procedure

- Capable of providing informed consent

- Able to complete online, in-person or phone surveys for the purposes of follow-up

- Capable of understanding pre- and post-procedure care instructions

- Ambulatory at baseline

- Previous trial and failure of conservative therapy consisting of a minimum of 6 weeks
of physical therapy and trial of anti-inflammatory medications if not contraindicated,
with or without concomitant bracing and/or injections.

Exclusion Criteria:

- Age < 35 or > 75 years old

- Radiographs demonstrating either no, little or severe osteoarthritis
(Kellgren-Lawrence Grade 0, 1 )

- Prior total or partial joint replacement surgery or a surgery involving cartilage
regeneration (microfracture, ACI, etc)

- Previous cortisone and/or Hyaluronic acid intra-articular injection within the last 3
months

- Co-morbidity with rheumatologic condition, inflammatory arthritis

- Currently undergoing immunomodulatory therapy

- Uncontrolled endocrine disorder

- BMI >35

- Current diagnosis of osteomyelitis, human immunodeficiency virus (HIV-1, -2) and/or
hepatitis C (HCV), infection and poorly controlled diabetes (HgA1C >7.0)

- Pregnancy or planned pregnancy

- previous stem cell injection into treatment joint

- Patient scheduled to undergo any concomitant surgical procedures.

- Coagulopathy or anticoagulant treatment

- Chronic pain involving multiple body parts or opioid medication management