Scleroderma Treatment With Celution Processed Adipose Derived Regenerative Cells (STAR)

Key Inclusion Criteria:

1. Males or females ≥ 18 and ≤ 70 years of age

2. Diagnosis of diffuse cutaneous scleroderma (duration > 5 years) or limited cutaneousscleroderma.

3. Cochin score ≥ 20 units

4. Ability to safely undergo liposuction

5. Symptoms consistent with Raynaud's Phemomena

6. Compliant with standard preventative recommendations

Key Exclusion Criteria:

1. Body Mass Index < 18 kg/m2

2. Active infection in any finger during screening period or infection in any fingerrequiring antibiotics in the 30 days prior to the Screening Visit

3. Active infection at the potential site(s) of fat harvest during the screening period

4. Contractures of any finger or ulceration at point of injection precluding completionof injection procedure

5. Amputation of any finger proximal to the proximal interphalangeal joint or anyamputation in more than one finger

6. Diagnosis of Rheumatoid Arthritis

7. Inflammatory arthritis of the hand, including significant osteoarthritis, that is notdue to scleroderma or significant acute inflammation in the hand that is due toscleroderma, as per the investigator's clinical judgment

8. Oral cyclophosphamide exceeding 2 mg/kg/day, any intravenous cyclophosphamide,methotrexate exceeding 25 mg/week, mycophenolate mofetil exceeding 3 gm/day,hydoxychloroquine exceeding 7 mg/kg/day or azathioprine exceeding 300 mg/day or anyother immunosuppressive medication in the 90 days prior to the Screening Visit