NCT02172937

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Jan 2011

Longer than P75 for phase_1

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2011

Completed
3.5 years until next milestone

First Submitted

Initial submission to the registry

June 17, 2014

Completed
7 days until next milestone

First Posted

Study publicly available on registry

June 24, 2014

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2016

Completed
Last Updated

November 11, 2014

Status Verified

November 1, 2014

Enrollment Period

5.9 years

First QC Date

June 17, 2014

Last Update Submit

November 8, 2014

Conditions

Graft vs Host Disease

Keywords

Stem Cell TransplantationDecidual Stromal Cells

Outcome Measures

Primary Outcomes (1)

  • Actuarial survival at six months after first DSC infusion

    6 months after inclusion

Secondary Outcomes (6)

  • Response at 28 days after onset of graft versus host disease

    28 days after inclusion

  • Response at 84 days after onset of graft versus host disease

    Up to 84 days after inclusion

  • Response at 168 days after onset of graft versus host disease

    Up to 168 days after inclusion

  • Side effects

    Up to 6 months after inclusion

  • Incidence of severe infections

    Up to one year after inclusion

  • +1 more secondary outcomes

Study Arms (2)

Decidual Stromal Cells as last line treatment

EXPERIMENTAL

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.

Biological: Decidual Stromal Cells thawed in plasma

Decidual Stromal Cells

ACTIVE COMPARATOR

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.

Biological: Decidual Stromal Cells thawed in human albumin

Interventions

Decidual Stromal Cells thawed in plasmaBIOLOGICAL
Decidual Stromal Cells as last line treatment
Decidual Stromal Cells thawed in human albuminBIOLOGICAL
Decidual Stromal Cells

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • None.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Karolinska Institutet

Stockholm, 14186, Sweden

RECRUITING

Related Publications (3)

  • Erkers T, Nava S, Yosef J, Ringden 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.

    PMID: 23701127BACKGROUND

  • Ringden 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.

    PMID: 23307526RESULT

  • Sadeghi B, Remberger M, Gustafsson B, Winiarski J, Moretti G, Khoein B, Klingspor L, Westgren M, Mattsson J, Ringden O. Long-Term Follow-Up of a Pilot Study Using Placenta-Derived Decidua Stromal Cells for Severe Acute Graft-versus-Host Disease. Biol Blood Marrow Transplant. 2019 Oct;25(10):1965-1969. doi: 10.1016/j.bbmt.2019.05.034. Epub 2019 Jun 4.

    PMID: 31173898DERIVED

MeSH Terms

Conditions

Graft vs Host Disease

Interventions

Serum Albumin, Human

Condition Hierarchy (Ancestors)

Immune System Diseases

Intervention Hierarchy (Ancestors)

Serum AlbuminAlbuminsProteinsAmino Acids, Peptides, and ProteinsBlood Proteins

Study Officials

  • Olle Ringdén, MD, PhD

    Karolinska Institutet

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Olle Ringdén, MD, PhD

CONTACT

+46858582672olle.ringden@ki.se

Helen Kaipe, PhD

CONTACT

+46700901052helen.kaipe@ki.se

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

June 17, 2014

First Posted

June 24, 2014

Study Start

January 1, 2011

Primary Completion

December 1, 2016

Study Completion

December 1, 2016

Last Updated

November 11, 2014

Record last verified: 2014-11

Locations

SE(1)