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

Launched by CYTORI THERAPEUTICS · Mar 23, 2015

Keywords

ClinConnect Summary

The STAR Trial is a prospective, randomized, multi-center device trial intended to assess safety and efficacy of subcutaneous administration of Celution processed ADRCs into fingers of patients with hand dysfunction due to scleroderma.

Following informed consent and screening evaluations, eligible subjects will undergo pre-operative testing. Subjects will then undergo fat harvest through small volume liposuction under local anesthesia. Lipoaspirate will be processed in the Celution System to isolate and concentrate ADRCs for immediate subcutaneous administration under local anesthesia. Sub...

Gender

ALL

Eligibility criteria

• Key Inclusion Criteria:
• • 1. Males or females ≥ 18 and ≤ 70 years of age
• • 2. Diagnosis of diffuse cutaneous scleroderma (duration \> 5 years) or limited cutaneous scleroderma.
• • 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 finger requiring 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 completion of injection procedure
• • 5. Amputation of any finger proximal to the proximal interphalangeal joint or any amputation in more than one finger
• • 6. Diagnosis of Rheumatoid Arthritis
• • 7. Inflammatory arthritis of the hand, including significant osteoarthritis, that is not due to scleroderma or significant acute inflammation in the hand that is due to scleroderma, 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 any other immunosuppressive medication in the 90 days prior to the Screening Visit