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

Study Overview
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Brief Summary
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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
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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.

Official Title
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Scleroderma Treatment With Celution Processed Adipose Derived Regenerative Cells (STAR): A Randomized, Double-Blind, Placebo-Controlled Trial With Incomplete Crossover

Conditions
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Scleroderma, Systemic Sclerosis, Raynaud Phenomena, Raynaud's Disease

Intervention / Treatment
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* Device: Celution Device
* Other: Placebo


Participation Criteria
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Eligibility Criteria
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Key Inclusion Criteria: Males or females ≥ 18 and ≤ 70 years of age Diagnosis of diffuse cutaneous scleroderma (duration > 5 years) or limited cutaneous scleroderma. Cochin score ≥ 20 units Ability to safely undergo liposuction Symptoms consistent with Raynaud's Phemomena Compliant with standard preventative recommendations Key Exclusion Criteria: Body Mass Index < 18 kg/m2 Active infection in any finger during screening period or infection in any finger requiring antibiotics in the 30 days prior to the Screening Visit Active infection at the potential site(s) of fat harvest during the screening period Contractures of any finger or ulceration at point of injection precluding completion of injection procedure Amputation of any finger proximal to the proximal interphalangeal joint or any amputation in more than one finger Diagnosis of Rheumatoid Arthritis 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 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Adipose Derived Regenerative Cells<br>Adipose Derived Regenerative Cells (ADRCs) processed by the Celution Device 40,000,000 ADRCs administered in 2 injections per digit on both hands. | Device: Celution Device<br>* ADRCs prepared using the investigational Celution Device<br>|
| Placebo Comparator: Placebo<br>Sterile Lactated Ringers Solution mixed with small amount of study subject's own freshly drawn blood and administered in 2 injections per digit on both hands. | Other: Placebo<br>* Placebo<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cochin score |  | 24 Weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cochin score |  | 48 Weeks | 
| Raynaud's Condition Score |  | 24 Weeks | 
| Scleroderma Health Assessment Questionnaire (SHAQ) |  | 24 Weeks |