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

Systemic Sclerosis Clinical Trial

— STAR  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02396238
• Other study ID #: STAR Trial
• Status: Completed
• Phase: N/A
• Start date: May 15, 2015
• Est. completion date: May 22, 2018

Study information

• Verified date: June 2018
• Source: Cytori Therapeutics
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 88
• Est. completion date: May 22, 2018
• Est. primary completion date: September 19, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Raynaud Disease
• Raynaud Phenomena
• Raynaud's Disease
• Scleroderma
• Scleroderma, Diffuse
• Scleroderma, Localized
• Scleroderma, Systemic
• Systemic Sclerosis

Intervention

Device:
• Celution Device
ADRCs prepared using the investigational Celution Device

Other:
• Placebo
Placebo

Locations

Country	Name	City	State
United States	Johns Hopkins University	Baltimore	Maryland
United States	Boston University Medical Center	Boston	Massachusetts
United States	Northwestern University	Chicago	Illinois
United States	Cleveland Clinic	Cleveland	Ohio
United States	Duke University Medical Center	Durham	North Carolina
United States	West Michigan Rheumatology, PLLC	Grand Rapids	Michigan
United States	University of Texas Houston Medical School	Houston	Texas
United States	Center For Pharmaceutical Research	Kansas City	Missouri
United States	Central Kentucky Research Associates, Inc.	Lexington	Kentucky
United States	Baptist Health Center for Clinical Research	Little Rock	Arkansas
United States	Arthritis Associates of Southern California	Los Angeles	California
United States	UCLA David Geffen School of Medicine	Los Angeles	California
United States	Robert Wood Johnson Medical School	New Brunswick	New Jersey
United States	Hospital for Special Surgery	New York	New York
United States	University of Pennsylvania	Philadelphia	Pennsylvania
United States	Arizona Arthritis and Rheumatology Research, PLLC	Phoenix	Arizona
United States	University of Pittsburgh	Pittsburgh	Pennsylvania
United States	Georgetown University Hospital	Washington	District of Columbia
United States	Heartland Research Associates	Wichita	Kansas

Sponsors (1)

Lead Sponsor	Collaborator
Cytori Therapeutics

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Cochin Score		up to 48 Weeks
Other	Raynaud's Condition Score		up to 48 Weeks
Other	Scleroderma Health Assessment Questionnaire (SHAQ)		up to 48 Weeks
Other	Physician and Patient Global Assessment		up to 48 Weeks
Other	Hand Mobility in Scleroderma (HAMIS)		up to 48 Weeks
Other	Digital ulcer count		up to 48 Weeks
Other	Modified Rodnan Score		up to 48 Weeks
Other	Grip strength and pinch strength		up to 48 Weeks
Other	Finger circumference (with hand volume)		up to 48 Weeks
Other	1st corner distance and sum of 2nd, 3rd and 4th corner distances		up to 48 Weeks
Other	The EuroQOL five dimensions questionnaire (EQ-5D)		up to 48 Weeks
Other	Adverse events, Serious Adverse Events		up to 48 Weeks
Primary	Cochin score		24 Weeks
Secondary	Cochin score		48 Weeks
Secondary	Raynaud's Condition Score		24 Weeks
Secondary	Scleroderma Health Assessment Questionnaire (SHAQ)		24 Weeks