Clinical Trials Logo

Clinical Trial Summary

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.


Clinical Trial Description

The STAR Trial is a prospective, randomized, multi-center device trial intended to assess safety and efficacy of subcutaneous administration of Celution processed ADRCs into fingers of patients with hand dysfunction due to scleroderma.

Following informed consent and screening evaluations, eligible subjects will undergo pre-operative testing. Subjects will then undergo fat harvest through small volume liposuction under local anesthesia. Lipoaspirate will be processed in the Celution System to isolate and concentrate ADRCs for immediate subcutaneous administration under local anesthesia. Subjects will be randomly assigned to receive ADRCs (40 million cells) or a visually-matched placebo in a 1:1 ratio. All subjects will receive subcutaneous administration of test substance (ADRC or placebo) into all fingers of both hands. Following completion of all 48 week visits and database lock, placebo treated subjects will be offered treatment with their ADRCs cells should they continue to qualify according to the inclusion/exclusion criteria and should they wish to be treated with ADRCs and agree to the fat harvest procedure. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT02396238
Study type Interventional
Source Cytori Therapeutics
Contact
Status Completed
Phase N/A
Start date May 15, 2015
Completion date May 22, 2018

See also
  Status Clinical Trial Phase
Completed NCT03274076 - Evaluation of Tofacitinib in Early Diffuse Cutaneous Systemic Sclerosis (dcSSc) Phase 1/Phase 2
Completed NCT04300426 - Safety and Efficacy of Anaerobic Cultivated Human Intestinal Microbiome Transplantation in Systemic Sclerosis (ReSScue) Phase 2
Recruiting NCT06058091 - RY_SW01 Cell Injection Therapy in Systemic Sclerosis Phase 1/Phase 2
Recruiting NCT04356755 - Subcutaneous Injections of ASC to Heal Digital Ulcers in Patients With Scleroderma. Phase 2
Suspended NCT06210945 - Study to Evaluate the Safety, Tolerability, and Activity of CM-101 in Patients With Systemic Sclerosis Phase 2
Not yet recruiting NCT05947682 - Manufacturing of Allogeneic Adipose Tissue-derived Mesenchymal Stromal Cells for Treatment of Severe Systemic Sclerosis N/A
Not yet recruiting NCT04303208 - Sirtuin 3 and Sirtuin 7 in Systemic Sclerosis N/A
Not yet recruiting NCT05177380 - Efficacy of a Personalized Rehabilitation Program of Facial Involvement in Systemic Sclerosis N/A
Recruiting NCT02551042 - CSL Behring Sclero XIII Phase 2
Terminated NCT02246348 - Evaluating Lung Doppler Signals in Patients With Systemic Sclerosis (SSc) N/A
Terminated NCT02243111 - Detecting Pulmonary Arterial Hypertension (PAH) in Patients With Systemic Sclerosis (SSc) by Ultrasound N/A
Completed NCT01933334 - Safety and Tolerability of Pirfenidone in Patients With Systemic Sclerosis−Related Interstitial Lung Disease (SSc-ILD) (LOTUSS) Phase 2
Completed NCT01468792 - Hemodynamic Changes in Connective Tissue Disease N/A
Terminated NCT00848107 - Open-Label Study of Oral Treprostinil in Digital Ulcers Phase 2
Completed NCT00984932 - Effect of Rosuvastatin on Systemic Sclerosis-related Pulmonary Hypertension Phase 3
Completed NCT00074568 - Scleroderma Registry
Not yet recruiting NCT06412614 - Evaluation of Patients With Systemic Sclerosis Without Specific or Associated Autoantibodies
Terminated NCT00622687 - Effect of Different Iloprost Doses on Symptoms in Systemic Sclerosis Phase 2
Recruiting NCT04464434 - Upfront Autologous HSCT Versus Immunosuppression in Early Diffuse Cutaneous Systemic Sclerosis Phase 4
Recruiting NCT04246528 - SPIN Self-Management Feasibility Trial With Progression to Full-scale Trial (SPIN-SELF) N/A