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

Graft vs Host Disease Clinical Trial

Official title:

Decidual Stromal Cells as Treatment for Acute Graft Versus Host Disease

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02172937
• Other study ID #: DSCGVHD002
• Status: Recruiting
• Phase: Phase 1/Phase 2
• First received: June 17, 2014
• Last updated: November 8, 2014
• Start date: January 2011
• Est. completion date: December 2016

Study information

• Verified date: November 2014
• Source: Karolinska Institutet
• Contact: Olle Ringdén, MD, PhD
• Phone: +46858582672
• Email: olle.ringden[@]ki.se
• Is FDA regulated: No
• Health authority: Sweden: Regional Ethical Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: December 2016
• Est. primary completion date: December 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Acute graft versus host disease grade 2-4.

• Are on calcineurin inhibitor and high dose corticosteroids.

Exclusion Criteria:

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Graft vs Host Disease

Intervention

Biological:
• Decidual Stromal Cells thawed in plasma

• Decidual Stromal Cells thawed in human albumin

Locations

Country	Name	City	State
Sweden	Karolinska Institutet	Stockholm

Sponsors (2)

Lead Sponsor	Collaborator
Karolinska Institutet	Karolinska University Hospital

Country where clinical trial is conducted

Sweden, 

References & Publications (2)

Erkers T, Nava S, Yosef J, Ringdén O, Kaipe H. Decidual stromal cells promote regulatory T cells and suppress alloreactivity in a cell contact-dependent manner. Stem Cells Dev. 2013 Oct 1;22(19):2596-605. doi: 10.1089/scd.2013.0079. Epub 2013 Jul 2. — View Citation

Ringdén O, Erkers T, Nava S, Uzunel M, Iwarsson E, Conrad R, Westgren M, Mattsson J, Kaipe H. Fetal membrane cells for treatment of steroid-refractory acute graft-versus-host disease. Stem Cells. 2013 Mar;31(3):592-601. doi: 10.1002/stem.1314. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Actuarial survival at six months after first DSC infusion		6 months after inclusion	No
Secondary	Response at 28 days after onset of graft versus host disease	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.	28 days after inclusion	No
Secondary	Response at 84 days after onset of graft versus host disease	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.	Up to 84 days after inclusion	No
Secondary	Response at 168 days after onset of graft versus host disease	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.	Up to 168 days after inclusion	No
Secondary	Side effects	Adverse effects related to the treatment.	Up to 6 months after inclusion	Yes
Secondary	Incidence of severe infections	Severe bacterial, viral and fungal infections.	Up to one year after inclusion	Yes
Secondary	Disease free survival	Survival free from relapse.	Up to one year after inclusion	Yes