A Pilot Study Using Placenta Derived Decidual Stromal Cells for Toxicity and Inflammation With Special Focus to the Allogeneic Hematopoietic Cell Transplantation Setting

Phase 1

• Conditions: Acute Lung Injury; Decidual Stromal Cells; Stem Cell Transplantation; Inflammation
• Interventions: Biological: Decidual stromal cell therapy

• Registration Number: NCT02175303
• Lead Sponsor: Karolinska Institutet

Brief Summary

To evaluate safety and efficacy using decidual stromal cell therapy for toxicity and inflammation, with special focus on allogeneic hematopoietic cell transplantation patients. The hypothesis to be tested is that the cells are safe to infuse and that they have an anti-inflammatory and healing effect.

Detailed Description

Patients with toxicity, inflammation or hemorrhages will receive decidual stromal cells at approximately 1x10\^6 cells/kg at one or more occasions at weekly intervals dependent on clinical response.

Study Timeline

• Study Start: 2013-12
• Status Verified: 2014-06
• Study First Submitted: 2014-06-24
• Study First Submitted QC: 2014-06-25
• Last Update Submitted: 2014-06-25
• Study First Posted: 2014-06-26
• Last Update Posted: 2014-06-26
• Primary Completion: 2017-12
• Study Completion: 2017-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 25

Inclusion Criteria

• Patients with toxicity, inflammation or hemorrhages.

Exclusion Criteria

• None

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Decidual stromal cell therapy for toxicity and inflammation	Decidual stromal cell therapy	Patients with toxicity, inflammation or hemorrhages will receive decidual stromal cells at approximately 1x10\^6 cells/kg at one or more occasions at weekly intervals dependent on clinical response.

Primary Outcome Measures

Name	Time	Method
Number of adverse events	Up to one year after inclusion

Secondary Outcome Measures

Name	Time	Method
Anti-inflammatory and reparatory effects regarding different lesions.	Up to one year after inclusion	Clinical, neurophysiological and radiological evaluation of the lesions in question.
Time to disappearance of hemorrhages.	Up to three months after inclusion
Time to disappearance of paresis and/or paresthesias.	Up to one year after inclusion
Time to disappearance of pain.	Up to one year after inclusion
Time to disappearance of pulmonary infiltrates	Up to one month after inclusion	Disappearance of inflammatory processes in the lung.
Time to disappearance of oxygen supplementation	Up to one month after inclusion
Incidence of severe infections	Up to one year after inclusion	Incidence of severe bacterial, viral and fungal infections.
Incidence of graft versus host disease	Up to one year after inclusion
Actuarial survival	Up to 5 years after inclusion

Trial Locations

Locations (1)

Karolinska Institutet; 🇸🇪 Stockholm, Sweden