Clinical trials: Remestemcel-L
Grade B aGVHD, Grade C aGVHD
A Prospective Study of Remestemcel-L, Ex-vivo Cultured Adult Human Mesenchymal Stromal Cells, for the Treatment of Pediatric Participants Who Have Failed to Respond to Steroid Treatment for Acute Graft-Versus-Host Disease (aGVHD)
The study plans to treat at least 60 pediatric participants, male and female, between the ages of 2 months and 17 years inclusive with aGVHD following allogeneic hematopoietic stem cell transplant (HSCT) that has failed to…
- Conditions
- Grade B aGVHD, Grade C aGVHD, Grade D aGVHD
- Trial name
- NCT02336230
- Testing
- remestemcel-L
- Where
- 20 sites in United States
- Volunteers
- 55 people
- Sponsor
- Mesoblast, Inc.
Crohn Colitis
Study of Mesenchymal Stem Cells for the Treatment of Medically Refractory Crohn's Colitis
Crohn's disease has several phenotypes (inflammatory, stricturing, fistulizing) and location (small bowel, ileocecal, colon, and perianal). Approximately one third of patients have inflammation limited to the colon.
- Trial name
- NCT04548583
- Testing
- Remestemcel-L
- Where
- United States
- Volunteers
- 7 people
- Sponsor
- The Cleveland Clinic
Ulcerative Colitis
Study of Mesenchymal Stem Cells for the Treatment of Medically Refractory Ulcerative Colitis (UC)
The purpose of this study is to determine the safety and efficacy of using remestemcel-L, an ex vivo culture-expanded adult allogeneic bone marrow derived mesenchymal stem cell product (MSCs) delivered by targeted endoscopic…
- Trial name
- UC (NCT04543994)
- Testing
- Remestemcel-L
- Where
- United States
- Volunteers
- 7 people
- Sponsor
- The Cleveland Clinic
Crohn's Disease
Evaluation of PROCHYMAL® for Treatment-refractory Moderate-to-severe Crohn's Disease
To provide open-label re-treatment with PROCHYMAL to participants enrolled in companion Protocol 603 to evaluate the safety in participants with active Crohn's disease who are resistant to standard Crohn's disease therapies.
- Trial name
- NCT01233960
- Testing
- Prochymal®
- Where
- 20 sites in United States, Australia and 1 more
- Volunteers
- 73 people
- Sponsor
- Mesoblast, Inc.
Grade B Acute Graft Versus Host Disease, Grade C Acute Graft Versus Host Disease
Safety Follow-up of Treatment With Remestemcel-L in Pediatric Participants Who Have Failed to Respond to Steroid Treatment for Acute GVHD
Ongoing safety assessment follow-up to Protocol MSB-GVHD001 (NCT02336230) of remestemcel-L treatment in pediatric participants with acute graft versus host disease (aGVHD), following allogeneic hematopoietic stem cell transplant…
- Conditions
- Grade B Acute Graft Versus Host Disease, Grade C Acute Graft Versus Host Disease, Grade D Acute Graft Versus Host Disease
- Trial name
- NCT02652130
- Testing
- Remestemcel-L
- Where
- 20 sites in United States
- Volunteers
- 32 people
- Sponsor
- Mesoblast, Inc.
GVHD - Graft-Versus-Host Disease
A Randomized, Double-Blind, Placebo-Controlled, Multicenter Phase III Trial of Remestemcel-L-rknd Added to Ruxolitinib for Grade III-IV Steroid-Refractory Acute Graft-Versus-Host Disease
This study is a randomized, double-blind, placebo-controlled, multicenter Phase III trial to compare the efficacy and safety of remestemcel-L-rknd (remestemcel-L), ex-vivo cultured adult human mesenchymal stromal cells (MSC)…
- Trial name
- NCT07568535
- Testing
- Remestemcel-L-rknd
- Volunteers
- 180 people
- Sponsor
- Mesoblast, Ltd.
Mesenchymal Stromal Cells, Remestemcel-L
MSCs in COVID-19 ARDS
The mortality rate in SARS-CoV-2-related severe ARDS is high despite treatment with antivirals, glucocorticoids, immunoglobulins, and ventilation.
- Conditions
- Mesenchymal Stromal Cells, Remestemcel-L, Acute Respiratory Distress Syndrome, COVID
- Trial name
- NCT04371393
- Testing
- Remestemcel-L
- Where
- 21 sites in United States
- Volunteers
- 223 people
- Sponsor
- Icahn School of Medicine at Mount Sinai
Moderate to Severe Acute Respiratory Distress Syndrome Associated With COVID-19
Intermediate-size Expanded Access Program (EAP), Mesenchymal Stromal Cells (MSC) for Acute Respiratory Distress Syndrome (ARDS) Due to COVID-19 Infection
The objectives of this intermediate-size expanded access protocol are to assess the safety and efficacy of remestemcel-L in participants with ARDS due to coronavirus infection 2019 (COVID-19).
- Trial name
- NCT04366830
- Testing
- Remestemcel-L
- Where
- United States
- Sponsor
- Mesoblast International Sàrl
Crohn's Disease
Safety and Treatment Outcome Study of PROCHYMAL® (Remestemcel-L) Intravenous Infusion in Subjects With Treatment-resistant Crohn's Disease
Protocol 620 provides PROCHYMAL(R) adult human mesenchymal cells to specifically chosen Crohn's disease patients at participating centers who typically have already demonstrated good response in another PROCHYMAL study, are not…
- Trial name
- NCT01510431
- Testing
- PROCHYMAL (remestemcel-L)
- Where
- 4 sites in United States
- Sponsor
- Mesoblast, Inc.
Multisystem Inflammatory Syndrome in Children (MIS-C) Associated With Coronavirus Disease (COVID-19)
Intermediate-size Expanded Access Program (EAP), Mesenchymal Stromal Cells (MSC) for Multisystem Inflammatory Syndrome in Children (MIS-C) Associated With Coronavirus Disease (COVID-19)
The objectives of this intermediate-size expanded access protocol are to assess the safety and efficacy of remestemcel-L in participants with MIS-C associated with COVID-19.
- Trial name
- NCT04456439
- Testing
- Remestemcel-L, Hydrocortisone, Diphenhydramine
- Sponsor
- Mesoblast International Sàrl