Phase I/II trial of AM01 (amnion-derived mesenchymal stem cells) for steroid-refractory acute graft-versus-host disease (GVHD) after allogeneic hematopoietic stem cell transplantatio

Phase 1

• Conditions: Steroid-refractory acute graft-versus-host disease (GVHD)

• Registration Number: JPRN-UMIN000029945
• Lead Sponsor: Hyogo College of Medicine

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2017-11-13
• Study Completion: 2019-12-31
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Pending
• Sex: All
• Target Recruitment: 12

Inclusion Criteria

Not provided

Exclusion Criteria

1. Has received more than one treatment for acute GVHD other than steroid 2. Presence of liver dysfunction other than GVHD (serum total bilirubin >2.0mg/dl or serum AST/ALT >3 times upper limit of normal) 3. Presence of kidney dysfunction (serum creatinine >2.0mg/dl) 4. Percutaneous oxygen saturation is less than 94% even under oxygen administration 5. Presence of an uncontrolled severe infection 6. Presence of severe hypersensitivity to bovine-derived constituents, human serum albumin and gentamicin 7. History of hypersensitivity to iodine or iodine-containing contrast agent 8. Previous participation in a study of any treatment with cell therapy product 9. Previous participation in a study of any investigational treatment within 12 weeks of agreement for this study 10. In pregnancy or breast-feeding 11. Considered as ineligible to this study

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<Safety> Adverse events related to infusion toxicity within 24 hours after administration of AM01

Secondary Outcome Measures

Name	Time	Method
<Safety> Adverse events within 52 weeks after first administration of AM01 <Efficacy> 1) Maintain a complete response (CR) more than 28 days 2) A CR or partial response (PR) at 4 weeks after first administration 3) The following points in 8, 12, 16, 20 and 24 weeks after first administration 1. Severity of acute GVHD 2. Onset/severity of chronic GVHD 3. Overall survival 4. Recurrence of primary disease 5. Outbreak of severe infection 6. Dose of steroid