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

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Karolinska Institute

Status and phase

Unknown
Phase 2
Phase 1

Conditions

Graft vs Host Disease

Treatments

Biological: Late Decidual stromal cell therapy
Biological: Early Decidual stromal cell therapy

Study type

Interventional

Funder types

Other

Identifiers

NCT02172924
DSCGVHD001

Details and patient eligibility

About

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.

Full 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.

Enrollment

30 estimated patients

Sex

All

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Non-Randomized

Interventional model

Single Group Assignment

Masking

None (Open label)

30 participants in 2 patient groups

Early Decidual Stromal Cells
Active Comparator group
Description:
Patients with therapy-refractory GVHD and on calcineurin inhibitor and high dose corticosteroids since no more than 7 days will be given Decidual Stromal Cell therapy.
Treatment:
Biological: Early Decidual stromal cell therapy
Late Decidual Stromal Cells
Active Comparator group
Description:
Patients with therapy-refractory GVHD and on calcineurin inhibitor and high dose corticosteroids for longer than 7 days will be given Decidual Stromal Cell therapy.
Treatment:
Biological: Late Decidual stromal cell therapy

Trial contacts and locations

1

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Central trial contact

Olle Ringdén, MD, PhD; Helen Kaipe, PhD

Data sourced from clinicaltrials.gov

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