Scleroderma Treatment With Celution Processed ADRCs Registry

Scleroderma Treatment With Celution Processed Adipose Derived Regenerative Cells (ADRCs) Registry

Status

Withdrawn

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02328625

Acronym

STAR

Enrollment

Registered

2014-12-31

Start date

2015-04-30

Completion date

2017-06-30

Last updated

2016-03-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Scleroderma

Keywords

Scleroderma, Device, ADRCs, adipose derived regenerative cells, hand

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.

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.

Interventions

None listed

Study design

Observational model

CASE_ONLY

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame
Change in Cochin score	Day 90

Secondary

Measure	Time frame
Raynaud's Condition Score	Days 7, 30, 90 and 180
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
EQ-5D	Days 7, 30, 90 and 180

Outcome results