A Phase 2 Study Using Placenta Derived Decidual Stromal Cells for Graft Versus Host Disease

Graft vs Host Disease Clinical Trial

Official title:

A Phase 2 Study Using Placenta Derived Decidual Stromal Cells for Graft Versus Host Disease

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02172924
• Other study ID #: DSCGVHD001
• 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

• Graft vs Host Disease

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