Ignite Creation Date:
2025-12-24 @ 7:48 PM
Ignite Modification Date:
2025-12-30 @ 7:56 PM
Study NCT ID:
NCT02175303
Status:
UNKNOWN
Last Update Posted:
2014-06-26
First Post:
2014-06-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
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
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D055371', 'term': 'Acute Lung Injury'}, {'id': 'D007249', 'term': 'Inflammation'}], 'ancestors': [{'id': 'D055370', 'term': 'Lung Injury'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 25}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2013-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-06', 'completionDateStruct': {'date': '2017-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2014-06-25', 'studyFirstSubmitDate': '2014-06-24', 'studyFirstSubmitQcDate': '2014-06-25', 'lastUpdatePostDateStruct': {'date': '2014-06-26', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-06-26', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of adverse events', 'timeFrame': 'Up to one year after inclusion'}], 'secondaryOutcomes': [{'measure': 'Anti-inflammatory and reparatory effects regarding different lesions.', 'timeFrame': 'Up to one year after inclusion', 'description': 'Clinical, neurophysiological and radiological evaluation of the lesions in question.'}, {'measure': 'Time to disappearance of hemorrhages.', 'timeFrame': 'Up to three months after inclusion'}, {'measure': 'Time to disappearance of paresis and/or paresthesias.', 'timeFrame': 'Up to one year after inclusion'}, {'measure': 'Time to disappearance of pain.', 'timeFrame': 'Up to one year after inclusion'}, {'measure': 'Time to disappearance of pulmonary infiltrates', 'timeFrame': 'Up to one month after inclusion', 'description': 'Disappearance of inflammatory processes in the lung.'}, {'measure': 'Time to disappearance of oxygen supplementation', 'timeFrame': 'Up to one month after inclusion'}, {'measure': 'Incidence of severe infections', 'timeFrame': 'Up to one year after inclusion', 'description': 'Incidence of severe bacterial, viral and fungal infections.'}, {'measure': 'Incidence of graft versus host disease', 'timeFrame': 'Up to one year after inclusion'}, {'measure': 'Actuarial survival', 'timeFrame': 'Up to 5 years after inclusion'}]}, 'conditionsModule': {'conditions': ['Acute Lung Injury', 'Decidual Stromal Cells', 'Stem Cell Transplantation', 'Inflammation']}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with toxicity, inflammation or hemorrhages.\n\nExclusion Criteria:\n\n* None'}, 'identificationModule': {'nctId': 'NCT02175303', 'briefTitle': 'A Pilot Study Using Placenta Derived Decidual Stromal Cells for Toxicity and Inflammation With Special Focus to the Allogeneic Hematopoietic Cell Transplantation Setting', 'organization': {'class': 'OTHER', 'fullName': 'Karolinska Institutet'}, 'orgStudyIdInfo': {'id': 'DSCINF001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Decidual stromal cell therapy for toxicity and inflammation', '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.', 'interventionNames': ['Biological: Decidual stromal cell therapy']}], 'interventions': [{'name': 'Decidual stromal cell therapy', 'type': 'BIOLOGICAL', 'description': 'Decidual stromal cells from placenta will be infused intravenously at approximately 1x10\\^6 cells/kg at one or more occasions at weekly intervals.', 'armGroupLabels': ['Decidual stromal cell therapy for toxicity and inflammation']}]}, 'contactsLocationsModule': {'locations': [{'zip': '14186', 'city': 'Stockholm', 'state': 'Stockholm County', 'status': 'RECRUITING', 'country': 'Sweden', 'contacts': [{'name': 'Olle Ringdén, MD, PhD', 'role': 'CONTACT', 'email': 'olle.ringden@ki.se', 'phone': '+46858582672'}, {'name': 'Olle Ringdén, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Karolinska Institutet', 'geoPoint': {'lat': 59.32938, 'lon': 18.06871}}], 'centralContacts': [{'name': 'Olle Ringdén, MD, PhD', 'role': 'CONTACT', 'email': 'olle.ringden@ki.se', 'phone': '+46858582672'}, {'name': 'Helen Kaipe, PhD', 'role': 'CONTACT', 'email': 'helen.kaipe@ki.se', 'phone': '+46700901052'}], 'overallOfficials': [{'name': 'Olle Ringdén, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Karolinska Institutet'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Karolinska Institutet', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Olle Ringdén', 'investigatorAffiliation': 'Karolinska Institutet'}}}}