Treatment of acute graft-versus-host disease after allogeneic stem cell transplantation with placenta derived decidua stroma cells (DSC) compared with best available treatment (BAT).

Phase 1

• Conditions: Steroid refractory acute GVHD; MedDRA version: 20.0Level: LLTClassification code 10068908Term: AGVHDSystem Organ Class: 10021428 - Immune system disorders; Therapeutic area: Diseases [C] - Immune System Diseases [C20]

• Registration Number: EUCTR2019-002186-36-SE
• Lead Sponsor: ppsala University Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-05-26
• Last Update Posted: 6 November 2023

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 56

Inclusion Criteria

1.Completed study informed consent form.
2.Male or female patients aged 18 or older
3.Have undergone HSCT from any donor source
4.Clinically diagnosed Grades II to IV acute GvHD as per standard criteria occurring after HSCT requiring systemic immune suppressive therapy.
5.Confirmed diagnosis of steroid refractory aGvHD.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 46
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 10

Exclusion Criteria

1.Has received systemic treatment for aGvHD apart from steroids.
2.Clinical presentation resembling de novo chronic GvHD or GvHD overlap syndrome
3.Presence of an active infection
4.Known human immunodeficiency virus infection (HIV).
5.Patients suffering on active tuberculosis or viral hepatitis.
6.Significant respiratory disease
7.Presence of severely impaired renal function
8.Presence of severely impaired liver function
9.Malignancy that has required treatment in the previous two years
10.Any corticosteroid therapy for indications other than aGvHD at doses > 1 mg/kg/day
11.History of progressive multifocal leuko-encephalopathy (PML).
12.Previous participation in a study of any investigational treatment agent within 30 days
13.Any condition that would, in the Investigator's judgment, interfere with full participation in the study
14.Known allergies, hypersensitivity, or intolerance to systemic immunosuppressive therapy.
15.Known hypersensitivity to dimethyl sulfoxide (DMSO)
16. Known hypersensitivity to Gentamycin
17.Patients with coagulopathy or history of past thrombo-embolic event
18.Uncontrolled hypertension
19.History of severe chronic history of heart disease
20.Pregnant or nursing (lactating) women

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified