NCT02328625

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.

Trial Health

15
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Apr 2015

Typical duration for all trials

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 23, 2014

Completed
8 days until next milestone

First Posted

Study publicly available on registry

December 31, 2014

Completed
3 months until next milestone

Study Start

First participant enrolled

April 1, 2015

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2016

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2017

Completed
Last Updated

March 17, 2016

Status Verified

March 1, 2016

Enrollment Period

1.3 years

First QC Date

December 23, 2014

Last Update Submit

March 15, 2016

Conditions

Scleroderma

Keywords

SclerodermaDeviceADRCsadipose derived regenerative cellshand

Outcome Measures

Primary Outcomes (1)

  • Change in Cochin score

    Day 90

Secondary Outcomes (5)

  • Change in Cochin score

    Days 30 and 180

  • Scleroderma Health Assessment Questionnaire (SHAQ)

    Days 7, 30, 90 and 180

  • Physician and Patient Global Assessment

    Days 7, 30, 90 and 180

  • Raynaud's Condition Score

    Days 7, 30, 90 and 180

  • EQ-5D

    Days 7, 30, 90 and 180

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients who are scheduled to receive or have received ADRCs prepared by Celution to treat hand scleroderma.

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Scleroderma, Diffuse

Condition Hierarchy (Ancestors)

Scleroderma, SystemicConnective Tissue DiseasesSkin and Connective Tissue DiseasesSkin Diseases

Study Officials

  • Steven Kesten

    Cytori Therapeutics

    STUDY CHAIR
0

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Target Duration
1 Year
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 23, 2014

First Posted

December 31, 2014

Study Start

April 1, 2015

Primary Completion

August 1, 2016

Study Completion

June 1, 2017

Last Updated

March 17, 2016

Record last verified: 2016-03