Systemic Sclerosis Clinical Trial
Official title:
EFFECTS OF THE MICRO REINJECTION OF AUTOLOGOUS ADIPOSE TISSUE IN THE FACE OF PATIENTS WITH SYSTEMIC SCLEROSIS
This prospective single-center study evaluates a current care procedure. It includes 14
patients diagnosed with SSc according to the ACR/EULAR criteria or the Leroy & Medsger
criteria of the disease. Patients are enrolled if they wish for a therapeutic care of their
face, have a Mouth Handicap in Systemic Sclerosis (MHISS) score greater than 20 (scale
0-48), a modified Rodnan skin score upper or equal to 1 on the face (scale 0-3), and a mouth
opening less than 55 millimeters. They should not have anticoagulant, anti-platelets
aggregation medication or a daily steroid dose upper 20mg per day. Their BMI should exceed
17.
Micro fat grafting is a minimally invasive and usual procedure performed under local
anesthesia. Fat tissue is harvested (around 50 milliliters) using a 14 gauge or 2 mm
diameter cannula from areas around the knees, the abdomen or the hips under a gentle
aspiration. Lipoaspirated fat is then filtrated by the PureGraft system that offers a
sterile, closed, single-use system, leading to a fast, consistent and controlled
preparation. Then, 10 to 25 milliliters of this purified fat product is transferred through
a 21 gauge or 0.8 mm diameter cannula in two or four points of the face, with the entry
points located around the mouth.
n/a
Intervention Model: Single Group Assignment, Masking: Open Label
| 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 |
NCT02243111 -
Detecting Pulmonary Arterial Hypertension (PAH) in Patients With Systemic Sclerosis (SSc) by Ultrasound
|
N/A | |
| Terminated |
NCT02246348 -
Evaluating Lung Doppler Signals in Patients With Systemic Sclerosis (SSc)
|
N/A | |
| Completed |
NCT01933334 -
Safety and Tolerability of Pirfenidone in Patients With Systemic SclerosisâRelated 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 |