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

NCT02396238 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 88

Last updated 2018-06-04

No results posted yet for this study

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.

Conditions

Interventions

DEVICE

Celution Device

ADRCs prepared using the investigational Celution Device

OTHER

Placebo

Placebo

Sponsors & Collaborators

  • Cytori Therapeutics

    lead INDUSTRY

Principal Investigators

  • Steven Kesten, MD · Cytori Therapeutics

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-05-15
Primary Completion
2017-09-19
Completion
2018-05-22

Countries

  • United States

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02396238 on ClinicalTrials.gov