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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT02172924
Other study ID # DSCGVHD001
Secondary ID
Status Not yet recruiting
Phase Phase 1/Phase 2
First received June 17, 2014
Last updated November 8, 2014
Start date January 2017
Est. completion date December 2019

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 the 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 1x10^6 cells/kg at one or more occasions at weekly intervals dependent on clinical response.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 30
Est. completion date December 2019
Est. primary completion date December 2019
Accepts healthy volunteers No
Gender Both
Age group N/A and older
Eligibility Inclusion Criteria:

- Acute graft versus host disease grade 2-4 or therapy resistant chronic graft versus host disease.

- Are on calcineurin inhibitor and high dose corticosteroids.

Exclusion Criteria:

- Terminally ill patients

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


Intervention

Biological:
Early Decidual stromal cell therapy
Intervention given within 7 days after corticosteroids.
Late Decidual stromal cell therapy
Intervention given after 7 days after corticosteroids.

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, 

Outcome

Type Measure Description Time frame Safety issue
Primary Actuarial survival at one year after onset of graft versus host disease 12 months after inclusion No
Secondary Response at 28 days after onset of graft versus host disease 28 days after inclusion No
Secondary Side effects Up to 6 months after inclusion Yes
Secondary Incidence of severe infections Up to 12 months after inclusion Yes
Secondary Disease free survival 12 months after inclusion No
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