SclerodermaSTARNCT02396238
Scleroderma Treatment With Celution Processed Adipose Derived Regenerative Cells (STAR)
A study testing Celution Device in people with Scleroderma and Systemic Sclerosis, run by Cytori Therapeutics at 19 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Scleroderma, Systemic Sclerosis, Raynaud Phenomena
- What is being tested?
- Celution Device
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 88 participants
- Where
- 19 sitesUnited States
- Study dates
- 15 May 2015to 22 May 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
19 sites in 1 country.
19 sites in 1 country
United States19 sites
Johns Hopkins University
Baltimore, Maryland, 21224
Boston University Medical Center
Boston, Massachusetts, 02118
Northwestern University
Chicago, Illinois, 60611
Cleveland Clinic
Cleveland, Ohio, 44195
Duke University Medical Center
Durham, North Carolina, 27710
West Michigan Rheumatology, PLLC
Grand Rapids, Michigan, 49546
University of Texas Houston Medical School
Houston, Texas, 77030
Center For Pharmaceutical Research
Kansas City, Missouri, 64114
Central Kentucky Research Associates, Inc.
Lexington, Kentucky, 40509
Baptist Health Center for Clinical Research
Little Rock, Arkansas, 72205
Arthritis Associates of Southern California
Los Angeles, California, 90045
UCLA David Geffen School of Medicine
Los Angeles, California, 90095
Robert Wood Johnson Medical School
New Brunswick, New Jersey, 08901
Hospital for Special Surgery
New York, New York, 10021
University of Pennsylvania
Philadelphia, Pennsylvania, 19104
Arizona Arthritis and Rheumatology Research, PLLC
Phoenix, Arizona, 85253
University of Pittsburgh
Pittsburgh, Pennsylvania, 15261
Georgetown University Hospital
Washington D.C., District of Columbia, 20007
Heartland Research Associates
Wichita, Kansas, 67207
About this study
Official title: Scleroderma Treatment With Celution Processed Adipose Derived Regenerative Cells (STAR): A Randomized, Double-Blind, Placebo-Controlled Trial With Incomplete Crossover
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.
Read the 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.
- Conditions
- Scleroderma, Systemic Sclerosis, Raynaud Phenomena, Raynaud's Disease
- Being tested
- Celution Device, Placebo
- Medical subject headings
- Scleroderma, Diffuse, Scleroderma, Systemic, Raynaud Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Celution DeviceDevice
ADRCs prepared using the investigational Celution Device
PlaceboOther
Placebo
| Study group | Role | What they receive |
|---|---|---|
| Adipose Derived Regenerative Cells | Experimental | Adipose Derived Regenerative Cells (ADRCs) processed by the Celution Device 40,000,000 ADRCs administered in 2 injections per digit on both hands. Receives: Device: Celution Device |
| Placebo | Placebo comparator | 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. Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cochin score
Measured: 24 Weeks
Secondary outcomes (3)
Cochin score
Measured: 48 Weeks
Raynaud's Condition Score
Measured: 24 Weeks
Scleroderma Health Assessment Questionnaire (SHAQ)
Measured: 24 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2015 (estimated)
- Study start15 May 2015
- Primary completion19 Sep 2017
- Study completion22 May 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for SclerodermaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 88 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cytori Therapeutics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Steven Kesten, MD, Study director, Cytori Therapeutics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02396238
- Sponsor's protocol ID
- STAR Trial
- Acronym
- STAR
- Status last verified
- Jun 2018
- First submitted
- 12 Mar 2015
- Last updated
- 4 Jun 2018
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Khanna D, Caldron P, Martin RW, Kafaja S, Spiera R, Shahouri S, Shah A, Hsu V, Ervin J, Simms R, Domsic RT, Steen V, Hummers LK, Derk C, Mayes M, Chatterjee S, Varga J, Kesten S, Fraser JK, Furst DE. Adipose-Derived Regenerative Cell Transplantation for the Treatment of Hand Dysfunction in Systemic Sclerosis: A Randomized Clinical Trial. Arthritis Rheumatol. 2022 Aug;74(8):1399-1408. doi: 10.1002/art.42133. Epub 2022 Jun 27.
PubMed 35358372
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Scleroderma Treatment With Celution Processed Adipose Derived Regenerative Cells (STAR): A Randomized, Double-Blind, Placebo-Controlled Trial With Incomplete Crossover
- ClinicalTrials.gov ID
- NCT02396238
- Acronym / sponsor ID
- STAR / STAR Trial
- Conditions
- Scleroderma, Systemic Sclerosis, Raynaud Phenomena, Raynaud's Disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 88 participants (actual)
- Lead sponsor
- Cytori TherapeuticsIndustry (pharma, biotech, devices)
- Study start
- 15 May 2015 (actual)
- Primary completion
- 19 Sep 2017 (actual)
- Study completion
- 22 May 2018 (actual)
- First posted
- 24 Mar 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Adipose Derived Regenerative Cells | Experimental | Device: Celution DeviceAdipose Derived Regenerative Cells (ADRCs) processed by the Celution Device 40,000,000 ADRCs administered in 2 injections per digit on both hands. |
| Placebo | Placebo comparator | Other: PlaceboSterile 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. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Celution DeviceADRCs prepared using the investigational Celution Device | Device | Adipose Derived Regenerative Cells |
| PlaceboPlacebo | Other | Placebo |
Primary outcome
Cochin score
Time frame: 24 Weeks
3 secondary outcomes
Cochin score
Time frame: 48 Weeks
Raynaud's Condition Score
Time frame: 24 Weeks
Scleroderma Health Assessment Questionnaire (SHAQ)
Time frame: 24 Weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jun 2018.
- Derived from this study: PubMed 35358372Khanna D, Caldron P, Martin RW, Kafaja S, Spiera R, Shahouri S, Shah A, Hsu V, Ervin J, Simms R, Domsic RT, Steen V, Hummers LK, Derk C, Mayes M, Chatterjee S, Varga J, Kesten S, Fraser JK, Furst DE. Adipose-Derived Regenerative Cell Transplantation for the Treatment of Hand Dysfunction in Systemic Sclerosis: A Randomized Clinical Trial. Arthritis Rheumatol. 2022 Aug;74(8):1399-1408. doi: 10.1002/art.42133. Epub 2022 Jun 27.
- Individual participant dataSharing planned: No
Related trials for Scleroderma
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A Phase 1/2 Study of NKX019 in Subjects With Immune-Mediated Diseases (Ntrust-2)
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Active, not recruitingObservational study
Cross-cultural Adaptation and Validation of the Localised Scleroderma Quality of Life Instrument (LoSQI) in Juvenile Localised Scleroderma (JLS)
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Steven Kesten, MD study director
Cytori Therapeutics
19 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Celution Device in people with Scleroderma and Systemic Sclerosis, run by Cytori Therapeutics at 19 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Jun 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 19 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cochin score (time frame: 24 Weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02396238, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Jun 2018.