Ignite Creation Date:
2024-10-26 @ 3:39 PM
Last Modification Date:
2024-10-26 @ 3:39 PM
Study NCT ID:
NCT06574581
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-08-01
Brief Title:
ADSCs Therapy in Patients With CTD-ILD
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Allogenic Adipose Tissue Derived-MSCs Therapy in Patients With Connective Tissue Diseases-associated Interstitial Lung DiseaseCTD-ILD Phase IIIa Clinical Trial
Status:
RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Connective tissue disease CTD an autoimmune and inflammatory disease usually accompanied by lung interstitialalveolar inflammation and fibrosis so called interstitial lung disease ILD The prevalence and mortality rate of CTD-ILD increase in recent several years Although the use of corticosteroids and strong immunosuppressants can improve ILD in some patients with CTD progressive lung fibrosis which needs lung transplantation and results in respiratory failure even with mortality is observed Currently stem cell therapy is a breakthrough in the treatment of CTD-ILD and the effective therapy with stem cells for patients with ILD have been reported
Detailed Description:
Mesenchymal stem cells MSCs are adult multipotent cells with self-renewal capacity and have immunomodulatory function By virtue of these properties they have an ability of tissues repairing as well as regeneration and have immunomodulatory function through an interaction with immune cells Compared with other MSCs adipose tissue derived-MSC AD-MSC are attainable by a less invasive method grow robustly and have a high proliferation capacity and a low immunogenicity Recently AD-MSC is widely employed in the field of cardiovascular diseases and autoimmune diseases without the emergence of serious adverse events
This is a Phase IIIa open-labelled without placebo group clinical trial to treat refractory or rapidly progressive ILD in 10 patients with CTD by intravenous transfusion with allogenic AD-MSC After signing the informed consent CTD-ILD patients will be enrolled in this trial including pre-treatment evaluation admission for intravenous transfusion with AD-MSC and post-infusion follow-up The initial 3 subjects will receive low-dose AD-MSC 1x10E6 cellskg infusion therapy only once if no adverse events after 4 weeks the next 4-7 subjects will receive AD-MSC 1x10E6 cellskg infusion therapy twice if no adverse events after 4 weeks of the last infusion the next 8-10 subjects will receive AD-MSC 1x10E6 cellskg infusion therapy three times The major aims of this trial are to improve the outcome of CTD patients with refractory ILD or rapidly progressive ILD and identify an optimal dose of the used AD-MSC
This is a Phase IIIa open-labelled without placebo group clinical trial to treat refractory or rapidly progressive ILD in 10 patients with CTD by intravenous transfusion with allogenic AD-MSC After signing the informed consent CTD-ILD patients will be enrolled in this trial including pre-treatment evaluation admission for intravenous transfusion with AD-MSC and post-infusion follow-up The initial 3 subjects will receive low-dose AD-MSC 1x10E6 cellskg infusion therapy only once if no adverse events after 4 weeks the next 4-7 subjects will receive AD-MSC 1x10E6 cellskg infusion therapy twice if no adverse events after 4 weeks of the last infusion the next 8-10 subjects will receive AD-MSC 1x10E6 cellskg infusion therapy three times The major aims of this trial are to improve the outcome of CTD patients with refractory ILD or rapidly progressive ILD and identify an optimal dose of the used AD-MSC
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None