Systemic Sclerosis Clinical Trial
Official title:
Subcutaneous Injection of Sodium Thiosulfate for Ectopic Calcifications or Ossifications. A Pilot Study
Ectopic soft tissue calcifications or ossifications can complicate the course of numerous diseases; most of them are rare or very rare. Even if the clinical, radiological and pathological presentation of ectopic calcifications and ossifications are different, the same hypotheses are discussed considering their hypothetical pathophysiology. Indeed, high calcium phosphate product, local cellular lesions and abnormal transdifferentiation of mesenchymal cells are regularly evoked when pathophysiology of such calcifications or ossifications are discussed. Apart from several case reports that have not been confirmed so far, no medical treatments are available, leading to significant pain and impairment of quality of life for patients. Therefore, only surgical treatment can be proposed when the volume or the consequences of these calcifications/ossifications become too important. Sodium thiosulfate (STS) is currently used as a cyanide poisoning antagonist and a chemoprotectant against adverse effects of several chemotherapies such as Cisplatin. Numerous case reports and several studies have revealed the potential interest of STS in the treatment of uremic induced vascular or soft tissues calcifications. Recently, our group has developed an expertise in the use of STS for the treatment of ectopic soft tissue calcifications or ossifications. Considering these promising preliminary data, and their limits, we developed a strategy to treat soft tissue calcifications or ossifications based on a local administration of STS. The first results of this therapeutic strategy are highly promising and the local or systemic safety is satisfactory so far. These preliminary data also reported by others deserve to be confirmed in a prospective study. We propose in this project to conduct a prospective open controlled phase II trial in order to assess the efficacy and the safety of intralesional administration of STS for the treatment of calcifications secondary to dermatomyositis or systemic sclerosis and ectopic ossifications secondary to pseudo-hypoparathyroidism 1a type (PHP1A/iPPSD2) (inactivating parathyroid hormone / parathyroid-hormone-related peptid (PTH/PTHrP) signalling disorder).
n/a
| 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 |
NCT05177380 -
Efficacy of a Personalized Rehabilitation Program of Facial Involvement in Systemic Sclerosis
|
N/A | |
| Not yet recruiting |
NCT04303208 -
Sirtuin 3 and Sirtuin 7 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 |