Ignite Creation Date:
2025-12-24 @ 7:56 PM
Ignite Modification Date:
2026-03-15 @ 8:37 AM
Study NCT ID:
NCT02438904
Status:
RECRUITING
Last Update Posted:
2025-12-01
First Post:
2015-05-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Compassionate Access of the Miltenyi Device for CD34+ Cell Selection
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2024-07-10', 'size': 215945, 'label': 'Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_000.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2025-01-31T17:27', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 200}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2015-05-06', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-11', 'completionDateStruct': {'date': '2027-05-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-11-24', 'studyFirstSubmitDate': '2015-05-06', 'studyFirstSubmitQcDate': '2015-05-07', 'lastUpdatePostDateStruct': {'date': '2025-12-01', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-05-08', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2027-05-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Increased Graft Function after Stem Cell Transplantation (SCT)', 'timeFrame': '4 weeks', 'description': 'Blood drawn for signs of graft versus host disease (GVHD).'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isUnapprovedDevice': True, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'keywords': ['Blood And Marrow Transplantation', 'Stem cell transplantation', 'SCT', 'Poor graft function', 'CD34+ cell infusion'], 'conditions': ['Blood And Marrow Transplantation']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://www.mdanderson.org', 'label': 'University of Texas MD Anderson Cancer Center'}]}, 'descriptionModule': {'briefSummary': 'Objectives:\n\nPrimary Objective\n\nTo provide compassionate access to the Miltenyi device for CD34+ cell infusions to patients who experience poor graft function after stem cell transplantation (SCT).', 'detailedDescription': "The therapy that you will receive involves you being given an infusion of CD34 positive stem cells.\n\nBelow is a detailed explanation of the therapeutic procedures that will be performed.\n\nCD34 positive stem cells infusion:\n\nThe CD34 positive stem cells are collected from a donor's blood. The blood cells go through CD34 (stem cell) selection process that collects the stem cells that are needed for the infusion. This process collects the early immune cells your body will need to regrow your immune system, and makes sure that other cells will not be infused. This process will decrease (but not eliminate completely) the other types of cells. If you agree to receive this treatment, the CD34 cells will then be infused into your body.\n\nThe CD34 positive cells will be given by vein in either an inpatient or outpatient treatment area. The infusion will last about 10-30 minutes.\n\nBefore the infusion, you will receive Tylenol (acetaminophen) by mouth and Benadryl (diphenhydramine hydrochloride) by mouth or vein about 30-60 minutes before the infusion. These drugs will be used to help lower the risk of side effects. If side effects occur during the infusion, the doses of the drugs may be adjusted (up or down) until the symptoms are gone. Also, if you have side effects during the infusion, you will be observed for 2 hours after it is given or until the symptoms have stopped completely (whichever is later). During this time, your blood pressure, heart rate, breathing rate, temperature, and the level of oxygen in your blood will be checked every 15-30 minutes.\n\nAbout 4-6 weeks after the first infusion, you may receive an additional infusion, if your doctor thinks it is needed.\n\nClinic Visits:\n\nOne (1) time a week after the infusion, until your doctor thinks it is no longer clinically needed, you will have the following tests:\n\n* Blood (about 1 teaspoon) will be drawn for routine tests.\n* You will be checked for signs of graft versus host disease (GVHD). Symptoms of GVHD include skin rash, nausea, vomiting, diarrhea, and abnormal liver function.\n\nThis is an investigational study. The CD34 positive stem cell infusion to help boost cell counts is not FDA approved.\n\nUp to 75 patients will be enrolled on this treatment."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1\\) Patients who have poor or no graft function post stem cell transplantation.\n\nExclusion Criteria:\n\nN/A'}, 'identificationModule': {'nctId': 'NCT02438904', 'briefTitle': 'Compassionate Access of the Miltenyi Device for CD34+ Cell Selection', 'organization': {'class': 'OTHER', 'fullName': 'M.D. Anderson Cancer Center'}, 'officialTitle': 'Compassionate Access of the Miltenyi Device for CD34+ Cell Selection', 'orgStudyIdInfo': {'id': '2015-0295'}, 'secondaryIdInfos': [{'id': 'NCI-2015-00979', 'type': 'REGISTRY', 'domain': 'NCI CTRP'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'CD34 Positive Stem Cell Infusion', 'description': 'Participants infused by vein with around 1 - 4 million/kg CD34+ selected cells. If the first infusion is not effective, an additional infusion may be given 4 - 6 weeks after the first infusion.', 'interventionNames': ['Biological: CD34 Positive Stem Cell Infusion', 'Device: Miltenyi device']}], 'interventions': [{'name': 'CD34 Positive Stem Cell Infusion', 'type': 'BIOLOGICAL', 'description': 'Participants infused by vein with around 1 - 4 million/kg CD34+ selected cells.', 'armGroupLabels': ['CD34 Positive Stem Cell Infusion']}, {'name': 'Miltenyi device', 'type': 'DEVICE', 'otherNames': ['CliniMACS device'], 'description': 'Miltenyi device is used for CD34+ cell infusions) to patients who experience poor graft function after stem cell transplantation (SCT).', 'armGroupLabels': ['CD34 Positive Stem Cell Infusion']}]}, 'contactsLocationsModule': {'locations': [{'zip': '77030', 'city': 'Houston', 'state': 'Texas', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'University of Texas MD Anderson Cancer Center', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}], 'centralContacts': [{'name': 'Elizabeth Shpall, MD', 'role': 'CONTACT', 'email': 'eshpall@mdanderson.org', 'phone': '713-745-2161'}], 'overallOfficials': [{'name': 'Elizabeth Shpall, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'M.D. Anderson Cancer Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'M.D. Anderson Cancer Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}