SclerodermaSTARNCT02328625
Scleroderma Treatment With Celution Processed ADRCs Registry
An observational study of Scleroderma, run by Cytori Therapeutics.
Trial summary
This registry study will assess the safety and performance of the Celution Device in the processing of an autologous graft consisting of adipose derived regenerative cells (ADRCs) in the treatment of hand scleroderma. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Scleroderma
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Apr 2015to Jun 2017
- How long will I take part?
- 1 Year
- Phase
- Observational
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients who are scheduled to receive or have received ADRCs prepared by Celution to treat hand scleroderma.
Who may be able to join
- Diagnosis of scleroderma and presence of hand scleroderma
- Cochin score ≥ 20 units
Who cannot join
- Body Mass Index < 17 kg/m2
- Infection in any finger
- Stable medications for the treatment of scleroderma for ≥ 1 month
- Pregnant or lactating status.
About this study
Official title: Scleroderma Treatment With Celution Processed Adipose Derived Regenerative Cells (ADRCs) Registry
This registry study will assess the safety and performance of the Celution Device in the processing of an autologous graft consisting of adipose derived regenerative cells (ADRCs) in the treatment of hand scleroderma.
Read the detailed description
This registry study will assess the safety and performance of the Celution System in preparation of adipose derived regenerative cells in the treatment of scleroderma affecting the hands. This will be a multi-center, multi-national study.
- Conditions
- Scleroderma
- Keywords
- Scleroderma, Device, ADRCs, adipose derived regenerative cells, hand
- Medical subject headings
- Scleroderma, Diffuse
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Cochin score
Measured: Day 90
Secondary outcomes (5)
Change in Cochin score
Measured: Days 30 and 180
Scleroderma Health Assessment Questionnaire (SHAQ)
Measured: Days 7, 30, 90 and 180
Physician and Patient Global Assessment
Measured: Days 7, 30, 90 and 180
Raynaud's Condition Score
Measured: Days 7, 30, 90 and 180
EQ-5D
Measured: Days 7, 30, 90 and 180
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Dec 2014 (estimated)
- Study startApr 2015
- Primary completionAug 2016 (estimated)
- Study completionJun 2017 (estimated)
Why it stopped: Corporate decision
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- Cytori Therapeutics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Steven Kesten, Study chair, Cytori Therapeutics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02328625
- Sponsor's protocol ID
- STAR Registry
- Acronym
- STAR
- Status last verified
- Mar 2016
- First submitted
- 23 Dec 2014
- Last updated
- 17 Mar 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Scleroderma Treatment With Celution Processed Adipose Derived Regenerative Cells (ADRCs) Registry
- ClinicalTrials.gov ID
- NCT02328625
- Acronym / sponsor ID
- STAR / STAR Registry
- Conditions
- Scleroderma
- Keywords
- Scleroderma, Device, ADRCs, adipose derived regenerative cells, hand
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: Corporate decision
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Cytori TherapeuticsIndustry (pharma, biotech, devices)
- Study start
- Apr 2015
- Primary completion
- Aug 2016 (estimated)
- Study completion
- Jun 2017 (estimated)
- First posted
- 31 Dec 2014 (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.
This registry study will assess the safety and performance of the Celution Device in the processing of an autologous graft consisting of adipose derived regenerative cells (ADRCs) in the treatment of hand scleroderma.
Detailed description
This registry study will assess the safety and performance of the Celution System in preparation of adipose derived regenerative cells in the treatment of scleroderma affecting the hands. This will be a multi-center, multi-national study.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Target follow-up
- 1 Year
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who are scheduled to receive or have received ADRCs prepared by Celution to treat hand scleroderma.
Key inclusion criteria (2 listed)
- Diagnosis of scleroderma and presence of hand scleroderma
- Cochin score ≥ 20 units
Key exclusion criteria (4 listed)
- Body Mass Index < 17 kg/m2
- Infection in any finger
- Stable medications for the treatment of scleroderma for ≥ 1 month
- Pregnant or lactating status.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Change in Cochin score
Time frame: Day 90
5 secondary outcomes
Change in Cochin score
Time frame: Days 30 and 180
Scleroderma Health Assessment Questionnaire (SHAQ)
Time frame: Days 7, 30, 90 and 180
Physician and Patient Global Assessment
Time frame: Days 7, 30, 90 and 180
Raynaud's Condition Score
Time frame: Days 7, 30, 90 and 180
EQ-5D
Time frame: Days 7, 30, 90 and 180
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Mar 2016.
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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 study chair
Cytori Therapeutics
Questions about this trial
What is this clinical trial studying?
An observational study of Scleroderma, run by Cytori Therapeutics.
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 2 inclusion and 4 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: withdrawn, as of the sponsor's last update on 17 Mar 2016. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. 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 was withdrawn before enrolling participants, so there are no results.
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?
Change in Cochin score (time frame: Day 90). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 17 Mar 2016.