Scleroderma Treatment With Celution Processed ADRCs Registry (STAR)

Cytori Therapeutics

Status: Withdrawn

Conditions: Scleroderma

Study type: Observational

Funder types: Industry

Identifiers

NCT02328625

STAR Registry

Details and patient eligibility

About

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.

Full 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.

Sex: All

Ages: 18+ years old

Volunteers: No 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.