Ignite Creation Date:
2024-05-06 @ 3:51 AM
Last Modification Date:
2024-10-26 @ 11:40 AM
Study NCT ID:
NCT02396238
Status:
COMPLETED
Last Update Posted:
2018-06-04
First Post:
2015-03-12
Brief Title:
Scleroderma Treatment With Celution Processed Adipose Derived Regenerative Cells STAR
Sponsor:
Cytori Therapeutics
Organization:
Cytori Therapeutics
Study Overview
Official Title:
Scleroderma Treatment With Celution Processed Adipose Derived Regenerative Cells STAR A Randomized Double-Blind Placebo-Controlled Trial With Incomplete Crossover
Status:
COMPLETED
Status Verified Date:
2018-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
STAR
Brief 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
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 11 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 inclusionexclusion criteria and should they wish to be treated with ADRCs and agree to the fat harvest procedure
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 11 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 inclusionexclusion criteria and should they wish to be treated with ADRCs and agree to the fat harvest procedure
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None