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Scleroderma Treatment With Celution Processed ADRCs Registry (STAR)

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ClinicalTrials.gov Identifier: NCT02328625
Recruitment Status : Withdrawn (Corporate decision)
First Posted : December 31, 2014
Last Update Posted : March 17, 2016
Sponsor:
Information provided by (Responsible Party):
Cytori Therapeutics

Brief 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.

Condition or disease
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.

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Study Type : Observational [Patient Registry]
Actual Enrollment : 0 participants
Observational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up Duration: 1 Year
Official Title: Scleroderma Treatment With Celution Processed Adipose Derived Regenerative Cells (ADRCs) Registry
Study Start Date : April 2015
Estimated Primary Completion Date : August 2016
Estimated Study Completion Date : June 2017





Primary Outcome Measures :
  1. Change in Cochin score [ Time Frame: Day 90 ]

Secondary Outcome Measures :
  1. Change in Cochin score [ Time Frame: Days 30 and 180 ]
  2. Scleroderma Health Assessment Questionnaire (SHAQ) [ Time Frame: Days 7, 30, 90 and 180 ]
  3. Physician and Patient Global Assessment [ Time Frame: Days 7, 30, 90 and 180 ]
  4. Raynaud's Condition Score [ Time Frame: Days 7, 30, 90 and 180 ]
  5. EQ-5D [ Time Frame: Days 7, 30, 90 and 180 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients who are scheduled to receive or have received ADRCs prepared by Celution to treat hand scleroderma.
Criteria

Inclusion Criteria:

  • Diagnosis of scleroderma and presence of hand scleroderma
  • Cochin score ≥ 20 units

Exclusion Criteria:

  • Body Mass Index < 17 kg/m2
  • Infection in any finger
  • Stable medications for the treatment of scleroderma for ≥ 1 month
  • Pregnant or lactating status.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02328625


Sponsors and Collaborators
Cytori Therapeutics
Investigators
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Study Chair: Steven Kesten Cytori Therapeutics

Additional Information:

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Responsible Party: Cytori Therapeutics
ClinicalTrials.gov Identifier: NCT02328625     History of Changes
Other Study ID Numbers: STAR Registry
First Posted: December 31, 2014    Key Record Dates
Last Update Posted: March 17, 2016
Last Verified: March 2016

Keywords provided by Cytori Therapeutics:
Scleroderma
Device
ADRCs
adipose derived regenerative cells
hand

Additional relevant MeSH terms:
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Scleroderma, Systemic
Scleroderma, Diffuse
Scleroderma, Localized
Connective Tissue Diseases
Skin Diseases