NCT02396238

Scleroderma Treatment With Celution Processed Adipose Derived Regenerative Cells (STAR)

Scleroderma Treatment With Celution Processed Adipose Derived Regenerative Cells (STAR): A Randomized, Double-Blind, Placebo-Controlled Trial With Incomplete Crossover

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 88 (actual)
• Sponsor: Cytori Therapeutics · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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 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.

Conditions

• Scleroderma
• Systemic Sclerosis
• Raynaud Phenomena
• Raynaud's Disease

Interventions

Type	Name	Description
DEVICE	Celution Device	ADRCs prepared using the investigational Celution Device
OTHER	Placebo	Placebo

Timeline

• Start date: 2015-05-15
• Primary completion: 2017-09-19
• Completion: 2018-05-22
• First posted: 2015-03-24
• Last updated: 2018-06-04

Locations

19 sites across 1 country: United States