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

• Sponsor: Karolinska Institutet (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT02175303
• Collaborator: (none)
• Enrollment: 25
• Location: 1
• Arm: 1
• Duration (Months): 48
• Patients Per Site Per Month: 0.5

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Acute Lung Injury; Decidual Stromal Cells; Stem Cell Transplantation; Inflammation	Biological: Decidual stromal cell therapy	Phase 1/Phase 2

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 Design

• Study Type: Interventional
• Anticipated Enrollment: 25 participants
• Allocation: Non-Randomized
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Study Start Date: Dec 1, 2013
• Anticipated Primary Completion Date: Dec 1, 2017
• Anticipated Study Completion Date: Dec 1, 2017

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Decidual stromal cell therapy for toxicity and inflammation 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.	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.

Outcome Measures

Primary Outcome Measures

1. Number of adverse events [Up to one year after inclusion]

Secondary Outcome Measures

1. Anti-inflammatory and reparatory effects regarding different lesions. [Up to one year after inclusion]

   Clinical, neurophysiological and radiological evaluation of the lesions in question.

2. Time to disappearance of hemorrhages. [Up to three months after inclusion]

3. Time to disappearance of paresis and/or paresthesias. [Up to one year after inclusion]

4. Time to disappearance of pain. [Up to one year after inclusion]

5. Time to disappearance of pulmonary infiltrates [Up to one month after inclusion]

   Disappearance of inflammatory processes in the lung.

6. Time to disappearance of oxygen supplementation [Up to one month after inclusion]

7. Incidence of severe infections [Up to one year after inclusion]

   Incidence of severe bacterial, viral and fungal infections.

8. Incidence of graft versus host disease [Up to one year after inclusion]

9. Actuarial survival [Up to 5 years after inclusion]

Eligibility Criteria

Criteria

• Ages Eligible for Study: N/A and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Patients with toxicity, inflammation or hemorrhages.

Exclusion Criteria:

• None

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Karolinska Institutet	Stockholm		Sweden	14186

Sponsors and Collaborators

• Karolinska Institutet

Investigators

• Principal Investigator: Olle Ringdén, MD, PhD, Karolinska Institutet

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Olle Ringdén, Professor, Karolinska Institutet
• ClinicalTrials.gov Identifier: NCT02175303
• Other Study ID Numbers: DSCINF001
• First Posted: Jun 26, 2014
• Last Update Posted: Jun 26, 2014
• Last Verified: Jun 1, 2014

• Additional relevant MeSH terms: Lung Injury; Acute Lung Injury; Inflammation

Study Results

No Results Posted as of Jun 26, 2014