CLINICAL_TRIALS ClinicalTrials.gov record with results posted

Donor-derived Mesenchymal Stromal Cells, Alemtuzumab, Co-stimulation Blockade and Sirolimus for Tolerance Induction in Adult Kidney Allograft Recipients (ITN062ST)

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Record identity and dates

Source: ClinicalTrials.gov
Source record ID: NCT03504241
Title field or adapter rule: {'original_value': 'Donor-derived Mesenchymal Stromal Cells, Alemtuzumab, Co-stimulation Blockade and Sirolimus for Tolerance Induction in Adult Kidney Allograft Recipients (ITN062ST)', 'source_field': 'protocolSection.identificationModule.officialTitle'}
Ingested At: 2026-10-30T01:05:27.904648+00:00
Published At: 2026-10-29T00:00:00+00:00
Record Updated At: 2026-10-29
Results Posted At: 2026-10-29
Source Retrieved At: 2026-10-30T01:05:26.713790+00:00
Timestamp Basis: ClinicalTrials.gov API/RSS response retrieval timestamp recorded by Dossier adapter
Date limitation: ClinicalTrials.gov API/RSS response retrieval timestamp recorded by Dossier adapter

Fields recorded by this source

protocolSection.conditionsModule.conditions: ["Kidney Transplantation", "Renal Transplantation", "Renal Transplant Recipient"]
protocolSection.statusModule.lastUpdatePostDateStruct: {"date": "2026-10-29", "type": "ACTUAL"}
protocolSection.identificationModule.nctId: "NCT03504241"
protocolSection.identificationModule.officialTitle: "Donor-derived Mesenchymal Stromal Cells, Alemtuzumab, Co-stimulation Blockade and Sirolimus for Tolerance Induction in Adult Kidney Allograft Recipients (ITN062ST)"
protocolSection.statusModule.overallStatus: "COMPLETED"
protocolSection.designModule.phases: ["PHASE1"]
protocolSection.statusModule.resultsFirstPostDateStruct: {"date": "2026-10-29", "type": "ACTUAL"}

Study condition terms

Interventions recorded in this study

{'armGroupLabels': ['MSCs 10^4 cells/kg+anti-rejection drugs', 'MSCs 10^5 cells/kg+anti-rejection drugs'], 'description': 'These MSCs were a cellular product derived from bone marrow and propagated ex vivo using FDA-approved, clinically applicable methods. Their use in kidney transplantation has been associated with a good safety profile.', 'name': 'Donor-derived Mesenchymal Stromal Cells', 'type': 'BIOLOGICAL'} (protocolSection.armsInterventionsModule.interventions[])
{'armGroupLabels': ['MSCs 10^4 cells/kg+anti-rejection drugs', 'MSCs 10^5 cells/kg+anti-rejection drugs'], 'description': 'Alemtuzumab, 30 mg, was given once intravenously (IV) over three hours. The infusion of alemtuzumab began within 24 hours of transplantation surgery and was given prior to the first dose of belatacept.', 'name': 'alemtuzumab', 'type': 'DRUG'} (protocolSection.armsInterventionsModule.interventions[])
{'armGroupLabels': ['MSCs 10^4 cells/kg+anti-rejection drugs', 'MSCs 10^5 cells/kg+anti-rejection drugs'], 'description': 'Belatacept was given as an intravenous (IV) infusion of 10mg /kg over 1 hour on transplantation postoperative Day 0, Days 5 and 14, then every 2 weeks (± 2 days) for 5 additional doses. Thereafter, belatacept was given once every 4 weeks (± 5 days) at 10 mg/kg through 24 weeks post-transplant, then at 5 mg/kg every 4-weeks until the participant was evaluated for belatacept discontinuation.', 'name': 'belatacept', 'type': 'DRUG'} (protocolSection.armsInterventionsModule.interventions[])
{'armGroupLabels': ['MSCs 10^4 cells/kg+anti-rejection drugs', 'MSCs 10^5 cells/kg+anti-rejection drugs'], 'description': 'Rapamune® (sirolimus) (Wyeth Pharmaceuticals Inc., Philadelphia, PA) was started on transplantation postoperative day 1 at a dose of 2 mg/day orally and adjusted to maintain goal 24-hour trough levels of 8-10 ng/ml. Participants who experienced grade 3 sirolimus toxicity underwent dose reduction.', 'name': 'sirolimus', 'type': 'DRUG'} (protocolSection.armsInterventionsModule.interventions[])
{'armGroupLabels': ['MSCs 10^4 cells/kg+anti-rejection drugs', 'MSCs 10^5 cells/kg+anti-rejection drugs'], 'description': 'Per protocol and was only permitted in cases of sirolimus intolerance.', 'name': 'mycophenolate mofetil', 'type': 'DRUG'} (protocolSection.armsInterventionsModule.interventions[])
{'armGroupLabels': ['MSCs 10^4 cells/kg+anti-rejection drugs', 'MSCs 10^5 cells/kg+anti-rejection drugs'], 'description': 'Per protocol and was only permitted in cases of sirolimus intolerance.', 'name': 'mycophenolate acid', 'type': 'DRUG'} (protocolSection.armsInterventionsModule.interventions[])
{'armGroupLabels': ['MSCs 10^4 cells/kg+anti-rejection drugs', 'MSCs 10^5 cells/kg+anti-rejection drugs'], 'description': 'Per protocol and was only permitted in cases of sirolimus intolerance.', 'name': 'prednisone', 'type': 'DRUG'} (protocolSection.armsInterventionsModule.interventions[])

An intervention appearing in a study record does not establish an effect or an approved use.

Drug names recorded in this source

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