An interventional study of Celution Device and Placebo in Scleroderma, Systemic Sclerosis and Raynaud Phenomena, sponsored by Cytori Therapeutics. Completed at 19 sites in United States. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2018-06-04.
Sponsored by Cytori Therapeutics · Not applicable, Interventional, and Treatment
Among 153 studies in Scleroderma, Diffuse with a site in United States — 29 open to participants now, 39 under way, 5 of them phase 3. Scleroderma, Diffuse · United States.
Among the 153 studies in Scleroderma, Diffuse with a site in United States, this one is the 31st largest by enrollment of the 120 interventional ones that give a count, is one of 6 that started in 2015, is one of 22 with no phase, and was the 71st registered.
310 studies on the registry are indexed under Scleroderma, Diffuse; 76 are open to participants now.
Browse Scleroderma, Diffuse studies →29 of the 153 studies in Scleroderma, Diffuse with a site in United States are open now. Recruiting first, the newest first:
Miltenyi Biomedicine GmbH · Sites in United States
Mediar Therapeutics · Sites in United States, Australia, France and 7 more countries
Galderma R&D · Sites in United States, Switzerland
Allogene Therapeutics · Sites in United States, Canada
Boston University · Sites in United States
A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →
Of the 55 Scleroderma, Diffuse studies recruiting now, 28 (51%) set no upper age limit and 20 (36%) stop at 75 or younger; 10 take children under 18; 10 take healthy volunteers.
This study: 18 Years to 70 Years · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
153 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 38 · Phase 2 62 · Phase 3 18 · Phase 4 2
First in 1992; this study’s year is marked. 6 started in 2015.
This study's enrollment of 88 is above the median of 38 across 227 interventional studies indexed under Scleroderma, Diffuse.
Median enrollment 29 across the 120 interventional studies, 197 across the 32 observational. Of the 100 that completed or were terminated, 40 (40%) have results posted.
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61 of 153 have an industry lead sponsor. The 10 most frequent:
Cytori Therapeutics is the lead sponsor of 19 studies on the registry; 2 are open to participants now.
Cytori Therapeutics has 2 studies filed under Scleroderma, Diffuse — fewer than ten, so there is no comparison to draw.
8 of the studies in Scleroderma, Diffuse with a site in United States that are under way reach primary completion within a year, 1 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT05925803Phase 3AstraZenecaDetermine Effectiveness of Anifrolumab In SYstemic Sclerosis (DAISY) | 2027-01-06 |
| NCT06195072Scleroderma Research Foundation, Inc.Platform Clinical Study for Conquering Scleroderma | 2026-11 |
| NCT03276923Duke UniversityMaternal Autoimmune Disease Research Alliance (MADRA) Registry | 2027-01-01 |
| NCT06152172David PorterCARTIMMUNE: Study of Patients With Autoimmune Diseases Receiving KYV-101 | 2027-02 |
| NCT06843239Zura Bio IncTibulizumab Systemic Sclerosis Understanding and Response Evaluation (TibuSURE) | 2027-05 |
Among the 153 studies in Scleroderma, Diffuse with a site in United States, from their registry updates:
This tab as a report to print or save as PDF → With an account.
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.
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.
Key Inclusion Criteria:
Key Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
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
ADRCs prepared using the investigational Celution Device
Placebo
Cochin score
Time frame: 24 Weeks
Cochin score
Time frame: 48 Weeks
Raynaud's Condition Score
Time frame: 24 Weeks
Scleroderma Health Assessment Questionnaire (SHAQ)
Time frame: 24 Weeks
Cochin Score
Time frame: up to 48 Weeks
Raynaud's Condition Score
Time frame: up to 48 Weeks
Scleroderma Health Assessment Questionnaire (SHAQ)
Time frame: up to 48 Weeks
Physician and Patient Global Assessment
Time frame: up to 48 Weeks
Hand Mobility in Scleroderma (HAMIS)
Time frame: up to 48 Weeks
Digital ulcer count
Time frame: up to 48 Weeks
Modified Rodnan Score
Time frame: up to 48 Weeks
Grip strength and pinch strength
Time frame: up to 48 Weeks
Finger circumference (with hand volume)
Time frame: up to 48 Weeks
1st corner distance and sum of 2nd, 3rd and 4th corner distances
Time frame: up to 48 Weeks
The EuroQOL five dimensions questionnaire (EQ-5D)
Time frame: up to 48 Weeks
Adverse events, Serious Adverse Events
Time frame: up to 48 Weeks
Plan to share: No
Ran from May 2015 to primary completion in Sep 2017, 28 months.
Of 53 interventional studies with no phase under Scleroderma, Diffuse, half reached primary completion within 16 months of starting (the median), counting those still running; a quarter within 4 and three quarters within 28. This study's 28 months is above that.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Jun 2018. You cannot join it, but the record below documents what was studied.
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Cytori Therapeutics