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

Information source: Karolinska Institutet
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Graft vs Host Disease

Intervention: Decidual Stromal Cells thawed in plasma (Biological); Decidual Stromal Cells thawed in human albumin (Biological)

Phase: Phase 1/Phase 2

Status: Recruiting

Sponsored by: Karolinska Institutet

Official(s) and/or principal investigator(s):
Olle Ringdén, MD, PhD, Principal Investigator, Affiliation: Karolinska Institutet

Overall contact:
Olle Ringdén, MD, PhD, Phone: +46858582672, Email: olle.ringden@ki.se

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.

Clinical Details

Official title: Decidual Stromal Cells as Treatment for Acute Graft Versus Host Disease

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

Primary outcome: Actuarial survival at six months after first DSC infusion

Secondary outcome:

Response at 28 days after onset of graft versus host disease

Response at 84 days after onset of graft versus host disease

Response at 168 days after onset of graft versus host disease

Side effects

Incidence of severe infections

Disease free survival

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.

Eligibility

Minimum age: N/A. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Acute graft versus host disease grade 2-4.

- Are on calcineurin inhibitor and high dose corticosteroids.

Exclusion Criteria: None.

Locations and Contacts

Olle Ringdén, MD, PhD, Phone: +46858582672, Email: olle.ringden@ki.se

Karolinska Institutet, Stockholm 14186, Sweden; Recruiting
Olle Ringdén, MD, PhD, Phone: +858582672, Email: olle.ringden@ki.se
Olle Ringdén, MD, PhD, Principal Investigator
Additional Information

Related publications:

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.

Starting date: January 2011
Last updated: November 8, 2014

Page last updated: August 23, 2015

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