Scleroderma, DiffusePhase 3STAR-IINCT05148598
ADRCs in The Treatment of Hand Dysfunction Due to Scleroderma
A Phase 3 study testing ADRCs in people with Scleroderma, Diffuse, run by Paracrine, INC..
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, Diffuse
- What is being tested?
- ADRCs
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 174 participants
- Where
- No sites listed yet
- Study dates
- 28 Feb 2023to 30 Dec 2025
- Phase
- Phase 3
- 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
- Diffuse cutaneous scleroderma (duration > 5 years)
- Cochin Hand Function Scale ≥ 20 units
- Symptoms consistent with Raynaud's Phenomenon
- Ability to safely undergo liposuction
Who cannot join
- Active infection
- Contracture(s) of any finger
- Sympathectomy within 6 months of Screening Visit
- Rheumatoid Arthritis
About this study
Official title: Scleroderma Treatment With Celution Processed Adipose Derived Regenerative Cells - A Randomized, Double-Blind, Placebo-Controlled Study - The STAR-II Trial
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 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.
- Conditions
- Scleroderma, Diffuse
- Being tested
- ADRCs, Standard Care, Placebo
- Keywords
- Hand Dysfunction, Scleroderma, Scleroderma, Diffuse
- Medical subject headings
- Scleroderma, Diffuse
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ADRCsDevice
Adipose Derived Regenerative Cells (ADRCs) processed with Celution System
Standard CareOther
Standard care
PlaceboOther
Placebo visually indistinguishable from ADRCs
| Study group | Role | What they receive |
|---|---|---|
| ADRC Arm | Experimental | Subjects in the ADRC arm will receive standard care and active treatment (ADRCs) Receives: Device: ADRCs; Other: Standard Care |
| Standard Care Arm | Placebo comparator | Subjects in the Standard Care arm will receive standard care and Placebo Receives: Other: Standard Care; Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cochin Hand Function Score
Cochin Hand Function Score
Measured: 26 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Dec 2021
- Study start28 Feb 2023 (estimated)
- Primary completion30 Dec 2024 (estimated)
- Study completion30 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Scleroderma, DiffuseStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- * Prospective * Randomized Parallel Group * Placebo-Controlled * Safety and Efficacy Trial
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 174 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Paracrine, INC.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05148598
- Sponsor's protocol ID
- STAR-II, 2021-03.V1
- Acronym
- STAR-II
- Status last verified
- Dec 2021
- First submitted
- 20 Nov 2021
- Last updated
- 28 Sep 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: Individual participant data (IPD) will not be made available.
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Scleroderma Treatment With Celution Processed Adipose Derived Regenerative Cells - A Randomized, Double-Blind, Placebo-Controlled Study - The STAR-II Trial
- ClinicalTrials.gov ID
- NCT05148598
- Acronym / sponsor ID
- STAR-II / STAR-II, 2021-03.V1
- Conditions
- Scleroderma, Diffuse
- Keywords
- Hand Dysfunction, Scleroderma, Scleroderma, Diffuse
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 174 participants (estimated)
- Lead sponsor
- Paracrine, INC.Industry (pharma, biotech, devices)
- Study start
- 28 Feb 2023 (estimated)
- Primary completion
- 30 Dec 2024 (estimated)
- Study completion
- 30 Dec 2025 (estimated)
- First posted
- 8 Dec 2021 (actual)
- 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 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- * Prospective * Randomized Parallel Group * Placebo-Controlled * Safety and Efficacy Trial
| Arm | Type | Receives |
|---|---|---|
| ADRC Arm | Experimental | Device: ADRCs, Other: Standard CareSubjects in the ADRC arm will receive standard care and active treatment (ADRCs) |
| Standard Care Arm | Placebo comparator | Other: Standard Care, Other: PlaceboSubjects in the Standard Care arm will receive standard care and Placebo |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Diffuse cutaneous scleroderma (duration > 5 years)
- Cochin Hand Function Scale ≥ 20 units
- Symptoms consistent with Raynaud's Phenomenon
- Ability to safely undergo liposuction
Key exclusion criteria (4 listed)
- Active infection
- Contracture(s) of any finger
- Sympathectomy within 6 months of Screening Visit
- Rheumatoid Arthritis
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 |
|---|---|---|
| ADRCsAdipose Derived Regenerative Cells (ADRCs) processed with Celution System | Device | ADRC Arm |
| Standard CareStandard care | Other | ADRC Arm, Standard Care Arm |
| PlaceboPlacebo visually indistinguishable from ADRCs | Other | Standard Care Arm |
Primary outcome
Cochin Hand Function Score
Time frame: 26 weeks
Cochin Hand Function Score
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Sep 2022.
- Individual participant dataSharing planned: No. Individual participant data (IPD) will not be made available.
Related trials for Scleroderma, Diffuse
Not yet recruitingPhase 2
Hyaluronidase Injections for Sclerodactyly in Patients With Scleroderma
Scleroderma, Sclerodactyly
RecruitingPhase 1
A Trial in Healthy Adult Participants and Adults With Autoimmune Diseases to Test How HBM7020 is Tolerated and How it Behaves in the Body
Rheumatoid Arthritis, Systemic Lupus Erythematosus
RecruitingObservational study
Quantification of Calcinosis Cutis Disease Burden Using Computed Tomography Images
Systemic Sclerosis (SSc), Calcinosis Cutis
RecruitingPhase 1/2
Phase I/II Study of AD-PluReceptor Plus Tafasitamab-cxix and Lymphodepleting Chemotherapy in Patients With Autoimmune Disorders
Autoimmune Disorders, Systemic Sclerosis
RecruitingPhase 1
A Study to Investigate the Safety and Preliminary Efficacy of ALLO-329, an Allogeneic CAR T-cell Therapy, in Adults With Autoimmune Disease
Systemic Lupus Erythematosus (With and Without Nephritis), Idiopathic Inflammatory Myopathy
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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing ADRCs in people with Scleroderma, Diffuse, run by Paracrine, INC..
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 4 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: status not confirmed, as of the sponsor's last update on 28 Sep 2022. 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. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
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 Hand Function Score (time frame: 26 weeks). 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 28 Sep 2022.