Back to resultsA Pilot Study Using Placenta Derived Decidual Stromal Cells for Toxicity and Inflammation With Special Focus to the Allogeneic Hematopoietic Cell Transplantation Setting
Primary Purpose
Acute Lung Injury, Decidual Stromal Cells, Stem Cell Transplantation
Status
Unknown status
Phase
Phase 1
Locations
Sweden
Study Type
Interventional
Intervention
Decidual stromal cell therapy
Sponsored by
About this trial
This is an interventional treatment trial for Acute Lung Injury
Eligibility Criteria
Inclusion Criteria:
- Patients with toxicity, inflammation or hemorrhages.
Exclusion Criteria:
- None
Sites / Locations
- Karolinska InstitutetRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Decidual stromal cell therapy for toxicity and inflammation
Arm 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.
Outcomes
Primary Outcome Measures
Number of adverse events
Secondary Outcome Measures
Anti-inflammatory and reparatory effects regarding different lesions.
Clinical, neurophysiological and radiological evaluation of the lesions in question.
Time to disappearance of hemorrhages.
Time to disappearance of paresis and/or paresthesias.
Time to disappearance of pain.
Time to disappearance of pulmonary infiltrates
Disappearance of inflammatory processes in the lung.
Time to disappearance of oxygen supplementation
Incidence of severe infections
Incidence of severe bacterial, viral and fungal infections.
Incidence of graft versus host disease
Actuarial survival
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02175303
Brief Title
A Pilot Study Using Placenta Derived Decidual Stromal Cells for Toxicity and Inflammation With Special Focus to the Allogeneic Hematopoietic Cell Transplantation Setting
Study Type
Interventional
2. Study Status
Record Verification Date
June 2014
Overall Recruitment Status
Unknown status
Study Start Date
December 2013 (undefined)
Primary Completion Date
December 2017 (Anticipated)
Study Completion Date
December 2017 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Karolinska Institutet
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Lung Injury, Decidual Stromal Cells, Stem Cell Transplantation, Inflammation
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
25 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Decidual stromal cell therapy for toxicity and inflammation
Arm Type
Experimental
Arm 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.
Intervention Type
Biological
Intervention Name(s)
Decidual stromal cell therapy
Intervention Description
Decidual stromal cells from placenta will be infused intravenously at approximately 1x10^6 cells/kg at one or more occasions at weekly intervals.
Primary Outcome Measure Information:
Title
Number of adverse events
Time Frame
Up to one year after inclusion
Secondary Outcome Measure Information:
Title
Anti-inflammatory and reparatory effects regarding different lesions.
Description
Clinical, neurophysiological and radiological evaluation of the lesions in question.
Time Frame
Up to one year after inclusion
Title
Time to disappearance of hemorrhages.
Time Frame
Up to three months after inclusion
Title
Time to disappearance of paresis and/or paresthesias.
Time Frame
Up to one year after inclusion
Title
Time to disappearance of pain.
Time Frame
Up to one year after inclusion
Title
Time to disappearance of pulmonary infiltrates
Description
Disappearance of inflammatory processes in the lung.
Time Frame
Up to one month after inclusion
Title
Time to disappearance of oxygen supplementation
Time Frame
Up to one month after inclusion
Title
Incidence of severe infections
Description
Incidence of severe bacterial, viral and fungal infections.
Time Frame
Up to one year after inclusion
Title
Incidence of graft versus host disease
Time Frame
Up to one year after inclusion
Title
Actuarial survival
Time Frame
Up to 5 years after inclusion
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients with toxicity, inflammation or hemorrhages.
Exclusion Criteria:
None
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Olle Ringdén, MD, PhD
Phone
+46858582672
Email
olle.ringden@ki.se
First Name & Middle Initial & Last Name or Official Title & Degree
Helen Kaipe, PhD
Phone
+46700901052
Email
helen.kaipe@ki.se
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Olle Ringdén, MD, PhD
Organizational Affiliation
Karolinska Institutet
Official's Role
Principal Investigator
Facility Information:
Facility Name
Karolinska Institutet
City
Stockholm
ZIP/Postal Code
14186
Country
Sweden
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Olle Ringdén, MD, PhD
Phone
+46858582672
Email
olle.ringden@ki.se
First Name & Middle Initial & Last Name & Degree
Olle Ringdén, MD, PhD
12. IPD Sharing Statement
Learn more about this trial
A Pilot Study Using Placenta Derived Decidual Stromal Cells for Toxicity and Inflammation With Special Focus to the Allogeneic Hematopoietic Cell Transplantation Setting
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