Stevens-Johnson Syndrome Clinical Trial
Official title:
Phase IIa Multicenter Clinical Trial to Determine the Feasibility and Safety of the Use of Adipose-derived Mesenchymal Stem Cells (ASC) in the Treatment of Patients With Cicatricial Conjunctivitis Associated With Lyell's Syndrome, Stevens-Johnson Syndrome and Pemphigoid of the Mucous Membranes With Ocular Involvement.
A phase IIa, open label, non controlled clinical trial to assess the feasibility and safety of allogeneic adipose-derived mesenchymal stem cells (ASC) in the treatment of cicatricial conjunctivitis associated with Lyell's syndrome, Stevens-Johnson's syndrome and mucous membrane pemphigoid with ocular involvement
A multicentre, nationwide clinical trial will be performed. 20 patients fulfilling eligibility criteria will be included in two different dose level cohorts: the first 10 patients included will receive a single cell application and the remainder 10 will be administered 2 cell applications separated by 15 days. The investigational drug consists of locally administered, expanded, allogeneic adipose-derived adult mesenchymal stem cells (ASCs), at a dose of 5 million cells per ml (0,5 ml to be infused per quadrant) Study cronogram: recruitment is estimated to take 8 months, and follow-up period will be 12 months. ;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Recruiting |
NCT03659227 -
Drug Reactions Sampling (COLLECTIONTOXIDERMIES)
|
||
| Completed |
NCT01696500 -
Phase III Clinical Trial of NPB-01 in Patients With Stevens-Johnson Syndrome/ Toxic Epidermal Necrolysis Unresponsive to Corticosteroids.
|
Phase 3 | |
| Terminated |
NCT02037347 -
Study to Evaluate the Use of Palifermin to Treat Toxic Epidermal Necrolysis
|
Phase 1/Phase 2 | |
| Withdrawn |
NCT02126020 -
Topical Infliximab in Autoimmune Eyes With Keratoprosthesis
|
Phase 1/Phase 2 | |
| Completed |
NCT06263140 -
Vitamin D Levels in Non-immediate Drug Hypersensitivity Case-control Study
|
||
| Available |
NCT02149732 -
Clinical Trial on the Effect of Autologous Oral Mucosal Epithelial Sheet Transplantation
|
Phase 1/Phase 2 | |
| Recruiting |
NCT05284929 -
Human Leukocyte Antigen Class II (DRB1 and DQB1) Alleles and Haplotypes Frequencies in Patients With Pemphigus Vulgaris Among the Russian Population
|
||
| Recruiting |
NCT02987257 -
NATIENS: Optimal Management and Mechanisms of SJS/TEN
|
Phase 3 | |
| Completed |
NCT02945176 -
Safety and Performance Study of the ARGOS-IO System in Patients Undergoing Boston Keratoprosthesis Implantation
|
N/A | |
| Not yet recruiting |
NCT03585946 -
Outcomes in Stevens Johnsons Syndrome and Toxic Epidermal Necrolysis
|
||
| Recruiting |
NCT04313725 -
Evaluation of Tangible Boost for Patients With Stevens Johnson Syndrome, Sjogren's Syndrome, and Graft Vs Host Disease
|
N/A | |
| Recruiting |
NCT03046914 -
HLA-B*5801 Screening to Prevent Allopurinol-induced Severe Cutaneous Adverse Reaction
|
N/A | |
| Completed |
NCT01488396 -
Efficacy of 0.05% Cyclosporin Eye Drop in Stevens Johnson Syndrome Patient With Chronic Dry Eye
|
Phase 4 | |
| Withdrawn |
NCT01256489 -
Infliximab to Improve Retention of the Boston Keratoprosthesis in Patients After Stevens Johnson Syndrome/ Toxic Epidermal Necrolysis (SJS/TENS)
|
Phase 1/Phase 2 | |
| Active, not recruiting |
NCT01122303 -
Corneal Epitheliotropic Factors in Autologous Serum Eye Drops in Nonautoimmune and Stevens-Johnson Syndrome With Dry Eye
|
N/A | |
| Recruiting |
NCT05145959 -
Meibomian Gland Probing in the Sub-Acute Phase of Patients With Stevens-Johnson Syndrome/Toxic Epidermal Necrolysis
|
N/A | |
| Completed |
NCT00844038 -
Stevens-Johnson Syndrome Antimicrobial
|
N/A |