Decidual Stromal Cells as Treatment for Acute Graft Versus Host Disease, a Phase 1-2 Study

Phase 1

• Conditions: Graft vs Host Disease
• Interventions: Biological: Decidual Stromal Cells thawed in human albumin; Biological: Decidual Stromal Cells thawed in plasma

• Registration Number: NCT02172937
• Lead Sponsor: Karolinska Institutet

Brief Summary

The purpose of this study is to evaluate safety and efficacy using decidual stromal cell therapy for graft versus host disease after allogeneic hematopoietic stem cell transplantation. The hypothesis to be tested is that the cells are safe to infuse and that they have a positive clinical effect.

Detailed Description

Patients with GVHD grade 2-4, will receive decidual stromal cells at approximately 1-2x10\^6 cells/kg at one or more occasions dependent on clinical response.

Study Timeline

• Study Start: 2011-01
• Study First Submitted: 2014-06-17
• Study First Submitted QC: 2014-06-23
• Study First Posted: 2014-06-24
• Status Verified: 2014-11
• Last Update Submitted: 2014-11-08
• Last Update Posted: 2014-11-11
• Primary Completion: 2016-12
• Study Completion: 2016-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

• Acute graft versus host disease grade 2-4.
• Are on calcineurin inhibitor and high dose corticosteroids.

Exclusion Criteria

None.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Decidual Stromal Cells	Decidual Stromal Cells thawed in human albumin	Patients with therapy-refractory GVHD and on calcineurin inhibitor and high dose corticosteroids will be given DSCs as early as possible at one or more occasions at weekly intervals dependent on clinical response. DSCs will be thawed from the freezer in plasma.
Decidual Stromal Cells as last line treatment	Decidual Stromal Cells thawed in plasma	Patients with therapy-refractory GVHD and on calcineurin inhibitor and high dose corticosteroids without any signs of improvement will be given DSCs to evaluate a possible effect. DSCs will be thawed from the freezer in plasma.

Primary Outcome Measures

Name	Time	Method
Actuarial survival at six months after first DSC infusion	6 months after inclusion

Secondary Outcome Measures

Name	Time	Method
Incidence of severe infections	Up to one year after inclusion	Severe bacterial, viral and fungal infections.
Response at 168 days after onset of graft versus host disease	Up to 168 days after inclusion	Response will be measured as: * Partial response (PR) if the patient has improved one grade in the overall GvH.; * Complete response (CR) if the patient is free of GvH.; * Non responder (NR) if the patient does not improve after treatment.
Side effects	Up to 6 months after inclusion	Adverse effects related to the treatment.
Disease free survival	Up to one year after inclusion	Survival free from relapse.
Response at 28 days after onset of graft versus host disease	28 days after inclusion	Response will be measured as: * Partial response (PR) if the patient has improved one grade in the overall GvH.; * Complete response (CR) if the patient is free of GvH.; * Non responder (NR) if the patient does not improve after treatment.
Response at 84 days after onset of graft versus host disease	Up to 84 days after inclusion	Response will be measured as: * Partial response (PR) if the patient has improved one grade in the overall GvH.; * Complete response (CR) if the patient is free of GvH.; * Non responder (NR) if the patient does not improve after treatment.

Trial Locations

Locations (1)

Karolinska Institutet; 🇸🇪 Stockholm, Sweden