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

Inflammation Clinical Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02175303
• Other study ID #: DSCINF001
• Status: Recruiting
• Phase: Phase 1/Phase 2
• First received: June 24, 2014
• Last updated: June 25, 2014
• Start date: December 2013
• Est. completion date: December 2017

Study information

• Verified date: June 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

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 25
• Est. completion date: December 2017
• Est. primary completion date: December 2017
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Patients with toxicity, inflammation or hemorrhages.

Exclusion Criteria:

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

• Acute Lung Injury
• Decidual Stromal Cells
• Inflammation
• Lung Injury
• Respiratory Distress Syndrome, Adult
• Stem Cell Transplantation

Intervention

Biological:
• Decidual stromal cell therapy
Decidual stromal cells from placenta will be infused intravenously at approximately 1x10^6 cells/kg at one or more occasions at weekly intervals.

Locations

Country	Name	City	State
Sweden	Karolinska Institutet	Stockholm

Sponsors (1)

Lead Sponsor	Collaborator
Karolinska Institutet

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of adverse events		Up to one year after inclusion	Yes
Secondary	Anti-inflammatory and reparatory effects regarding different lesions.	Clinical, neurophysiological and radiological evaluation of the lesions in question.	Up to one year after inclusion	No
Secondary	Time to disappearance of hemorrhages.		Up to three months after inclusion	No
Secondary	Time to disappearance of paresis and/or paresthesias.		Up to one year after inclusion	No
Secondary	Time to disappearance of pain.		Up to one year after inclusion	No
Secondary	Time to disappearance of pulmonary infiltrates	Disappearance of inflammatory processes in the lung.	Up to one month after inclusion	No
Secondary	Time to disappearance of oxygen supplementation		Up to one month after inclusion	No
Secondary	Incidence of severe infections	Incidence of severe bacterial, viral and fungal infections.	Up to one year after inclusion	Yes
Secondary	Incidence of graft versus host disease		Up to one year after inclusion	Yes
Secondary	Actuarial survival		Up to 5 years after inclusion	No