NCT05148598尚未招募3 期

Scleroderma Treatment With Celution Processed Adipose Derived Regenerative Cells - A Randomized, Double-Blind, Placebo-Controlled Study - The STAR-II Trial

Paracrine, INC.0 个研究点目标入组 174 人开始时间: 2023年2月28日最近更新: 2022年9月28日

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型: Interventional
分配方式: Randomized
干预模型: Parallel
主要目的: Treatment
盲法: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

盲法说明

Placebo is visually indistinguishable from active treatment.

入排标准

年龄范围: 18 Years 至 70 Years（Adult, Older Adult）
性别: All
接受健康志愿者: 否

入选标准

•Diffuse cutaneous scleroderma (duration > 5 years)
•Cochin Hand Function Scale ≥ 20 units
•Symptoms consistent with Raynaud's Phenomenon
•Ability to safely undergo liposuction

排除标准

•Active infection
•Contracture(s) of any finger
•Sympathectomy within 6 months of Screening Visit
•Rheumatoid Arthritis

结局指标

主要结局

Cochin Hand Function Score

时间窗: 26 weeks

Cochin Hand Function Score

次要结局

未报告次要终点

研究者

发起方

Paracrine, INC.

申办方类型

Industry

责任方

Sponsor

相似试验

已完成

不适用

Scleroderma Treatment With Celution Processed Adipose Derived Regenerative Cells (STAR)Raynaud PhenomenaRaynaud's DiseaseSystemic SclerosisScleroderma

NCT02396238Cytori Therapeutics88

撤回

不适用

Scleroderma Treatment With Celution Processed ADRCs RegistryScleroderma

NCT02328625Cytori Therapeutics

已完成

1 期

Treatment of Chronic Wounds in Diabetic Foot Syndrome With Allogeneic Adipose Derived Mesenchymal Stem CellsDiabetic Foot Ulcer

NCT03865394Medical University of Warsaw46

Unknown

不适用

Evaluate the Use of Liposuction and Cell Separation Devices for Autologous Fat (Adipose) Derived Cells to Treat the Symptoms of Erectile DysfunctionErectile Dysfunction

NCT01601353Tissue Genesis30

进行中（未招募）

早期 1 期

Clinical Study of Allogeneic Fat Decellularized Active Protein in the Treatment of Pulmonary FibrosisPulmonary Fibrosis

NCT05883293Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University7