Scleroderma Treatment With Celution Processed ADRCs Registry

Scleroderma Clinical Trial

— STAR  

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02328625
• Other study ID #: STAR Registry
• Status: Withdrawn
• Phase: N/A
• First received: December 23, 2014
• Last updated: March 15, 2016
• Start date: April 2015
• Est. completion date: June 2017

Study information

• Verified date: March 2016
• Source: Cytori Therapeutics
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Research Ethics Committee
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: June 2017
• Est. primary completion date: August 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Scleroderma
• Scleroderma, Diffuse
• Scleroderma, Localized
• Scleroderma, Systemic

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Cytori Therapeutics

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Cochin score		Day 90	No
Secondary	Change in Cochin score		Days 30 and 180	No
Secondary	Scleroderma Health Assessment Questionnaire (SHAQ)		Days 7, 30, 90 and 180	No
Secondary	Physician and Patient Global Assessment		Days 7, 30, 90 and 180	No
Secondary	Raynaud's Condition Score		Days 7, 30, 90 and 180	No
Secondary	EQ-5D		Days 7, 30, 90 and 180	No