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Mesenchymal Stem Cells

Prochymal® for Graft-versus-Host Disease

Phase 2
Waitlist Available
Research Sponsored by Mesoblast, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
All Individual Drugs Already Approved
No Placebo-Only Group

Summary

This study is designed to evaluate the safety and efficacy of Prochymal® (Ex-vivo Cultured Adult Human Mesenchymal Stem Cells) in participants experiencing treatment-refractory acute GVHD, Grades III-IV, that is refractory to standard first-line therapies and at least one second-line therapy.

Eligible Conditions
  • Graft-versus-Host Disease

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Side effects data

From 2018 Phase 3 trial • 55 Patients • NCT02336230
24%
Pyrexia
19%
Adenovirus infection
19%
Hypertension
19%
Abdominal pain
17%
Vomiting
15%
Arthralgia
15%
Hypotension
13%
Oedema peripheral
13%
Epstein-Barr viraemia
13%
Hypokalaemia
13%
Hyperglycaemia
13%
Cough
11%
Hypomagnesaemia
11%
Chronic graft versus host disease
11%
Hypogammaglobulinaemia
11%
Diarrhoea
9%
Sinus tachycardia
9%
Adrenal insufficiency
9%
Cushingoid
9%
Transaminases increased
9%
Hyponatraemia
9%
Multiple organ dysfunction syndrome
9%
BK virus infection
9%
Cystitis haemorrhagic
9%
Respiratory failure
7%
Abdominal distension
7%
Haematochezia
7%
Alanine aminotransferase increased
7%
Dysuria
7%
Epistaxis
7%
Epstein-Barr virus infection
7%
Urinary tract infection
7%
Hypophosphataemia
7%
Pain in extremity
7%
Headache
7%
Agitation
7%
Acute kidney injury
7%
Pneumatosis intestinalis
7%
Gastrointestinal haemorrhage
7%
Anaemia
6%
Neutropenia
6%
Constipation
6%
Flatulence
6%
Nausea
6%
Generalised oedema
6%
Allergic transfusion reaction
6%
Blood creatinine increased
6%
Hypoxia
6%
Electrocardiogram QT prolonged
6%
Malnutrition
6%
Dry skin
6%
Cytomegalovirus infection
6%
Oral candidiasis
6%
Pneumonia fungal
6%
Hyperkalaemia
6%
Hypernatraemia
6%
Hypertriglyceridaemia
6%
Hypoalbuminaemia
6%
Joint swelling
6%
Tremor
6%
Anxiety
6%
Insomnia
6%
Rash papular
6%
Skin ulcer
6%
Hyperbilirubinaemia
6%
Acute graft versus host disease
6%
Staphylococcal infection
6%
Pericardial effusion
6%
Skin hyperpigmentation
6%
Tachycardia
6%
Graft versus host disease in skin
4%
Escherichia urinary tract infection
4%
Pneumonia
4%
Sepsis
4%
Dehydration
4%
Acute respiratory distress syndrome
4%
Human herpesvirus 6 infection
4%
Staphylococcal bacteraemia
4%
Posterior reversible encephalopathy syndrome
4%
Respiratory distress
4%
Acute myeloid leukaemia recurrent
4%
Acute respiratory failure
4%
Haemolytic uraemic syndrome
2%
Haemolysis
2%
Thrombotic microangiopathy
2%
Cardiac arrest
2%
Cardiac failure
2%
Lower gastrointestinal haemorrhage
2%
Asthenia
2%
Clostridium difficile infection
2%
Enterococcal infection
2%
Fungaemia
2%
Fungal infection
2%
Gastroenteritis
2%
Lactobacillus infection
2%
Rotavirus infection
2%
Platelet count decreased
2%
Hypermetabolism
2%
Metabolic acidosis
2%
Capillary leak syndrome
2%
Hypertensive crisis
2%
Hypovolaemic shock
2%
Venoocclusive disease
2%
Pancytopenia
2%
Febrile neutropenia
2%
Cellulitis
2%
Acute megakaryocytic leukaemia
2%
Somnolence
2%
Graft versus host disease
2%
White blood cell count decreased
2%
Jejunal perforation
2%
Staphylococcal sepsis
2%
Pleural effusion
2%
Shock haemorrhagic
2%
Pulmonary mass
2%
Peripheral ischaemia
100%
80%
60%
40%
20%
0%
Study treatment Arm
Remestemcel-L 2×10^6 MSCs/kg

Awards & Highlights

All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: Prochymal®Experimental Treatment1 Intervention
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Remestemcel-L
FDA approved

Find a Location

Who is running the clinical trial?

Mesoblast, Inc.Lead Sponsor
21 Previous Clinical Trials
2,430 Total Patients Enrolled
Mahboob Rahman, MDStudy DirectorMesoblast, Inc.
11 Previous Clinical Trials
1,079 Total Patients Enrolled
Christopher James, PAStudy DirectorMesoblast, Inc.
3 Previous Clinical Trials
484 Total Patients Enrolled
~1 spots leftby Nov 2025
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