Raynaud Phenomena, Raynaud's Disease, Scleroderma, Systemic Sclerosis
Conditions
Brief summary
The primary objective of this study is to assess the safety and efficacy of the Celution Device in the processing of an autologous graft consisting of adipose derived regenerative cells (ADRCs) in the treatment of hand dysfunction due to scleroderma.
Detailed description
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. Subjects will be randomly assigned to receive ADRCs (40 million cells) or a visually-matched placebo in a 1:1 ratio. All subjects will receive subcutaneous administration of test substance (ADRC or placebo) into all fingers of both hands. Following completion of all 48 week visits and database lock, placebo treated subjects will be offered treatment with their ADRCs cells should they continue to qualify according to the inclusion/exclusion criteria and should they wish to be treated with ADRCs and agree to the fat harvest procedure.
Interventions
DEVICECelution Device
ADRCs prepared using the investigational Celution Device
OTHERPlacebo
Placebo
Sponsors
Cytori Therapeutics
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Cochin score | 24 Weeks |
Secondary
| Measure | Time frame |
|---|---|
| Cochin score | 48 Weeks |
| Raynaud's Condition Score | 24 Weeks |
| Scleroderma Health Assessment Questionnaire (SHAQ) | 24 Weeks |
Other
| Measure | Time frame |
|---|---|
| Hand Mobility in Scleroderma (HAMIS) | up to 48 Weeks |
| Digital ulcer count | up to 48 Weeks |
| Modified Rodnan Score | up to 48 Weeks |
| Grip strength and pinch strength | up to 48 Weeks |
| Cochin Score | up to 48 Weeks |
| 1st corner distance and sum of 2nd, 3rd and 4th corner distances | up to 48 Weeks |
| The EuroQOL five dimensions questionnaire (EQ-5D) | up to 48 Weeks |
| Adverse events, Serious Adverse Events | up to 48 Weeks |
| Finger circumference (with hand volume) | up to 48 Weeks |
| Raynaud's Condition Score | up to 48 Weeks |
| Scleroderma Health Assessment Questionnaire (SHAQ) | up to 48 Weeks |
| Physician and Patient Global Assessment | up to 48 Weeks |
Countries
United States
Outcome results
None listed