MSCs Combined With CD25 Monoclonal Antibody and Calcineurin Inhibitors for Treatment of Steroid-resistant aGVHD
NCT ID: NCT02241018
Last Updated: 2014-09-16
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE2/PHASE3
200 participants
INTERVENTIONAL
2014-09-30
2018-12-31
Brief Summary
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Detailed Description
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Mesenchymal stromal cells (MSCs) are a form of multipotent adult stem cells that can be isolated from many tissues, such as bone marrow (BM), adipose tissue and umbilical cord. Such cells possess the capacity to suppress immunological responses, support hematopoiesis and repair tissues. Clinical applications of human MSCs are evolving rapidly for preventing and treating GVHD. Although the results are still controversy, most prospective and retrospective data suggest that MSCs are effective to aGVHD.
In the present study, the investigators will prospectively evaluate the efficacy and safety of ex-vivo-expanded BM-derived MSCs from third-party donors combined with CD25 monoclonal antibody and calcineurin inhibitors in treating patients with aGVHD.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Mesenchymal stem cells
MSCs will be given at a median dose of 1×10\^6 cells/kg once weekly for 4 dose (as 1 cycle) or until CR. The response should be evaluated at 3 and 4 weeks. If symptoms of aGVHD progress at 3 weeks or the patients have NR at 4 weeks, these patients will switch to other therapy. If patients achieved PR at 4 weeks, another cycle will be given. Besides, CD25 monoclonal antibody (20mg/kg) will be administered at day 1,4,8,15, 21 and calcineurin inhibitors will also be used.
CD25 monoclonal antibody
calcineurin inhibitors
MSCs
CD25 Mc Ab & calcineurin inhibitors
CD25 monoclonal antibody (20mg/kg, day 1,4,8,15,21) will be administered combined with calcineurin inhibitors. The response should be evaluated at 3 and 4 weeks. If symptoms of aGVHD progress at 3 weeks or the patients have NR at 4 weeks, these patients will switch to other therapy. If patients achieved PR at 4 weeks, another cycle will be given.
CD25 monoclonal antibody
calcineurin inhibitors
Interventions
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CD25 monoclonal antibody
calcineurin inhibitors
MSCs
Eligibility Criteria
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Inclusion Criteria
* steroid-resistant aGVHD
* subjects (or their legally acceptable representatives) must have signed an informed consent document
Exclusion Criteria
* Patients with any conditions not suitable for the trial (investigators' decision)
14 Years
65 Years
ALL
No
Sponsors
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Guangdong Provincial People's Hospital
OTHER
Third Affiliated Hospital, Sun Yat-Sen University
OTHER
Guangzhou General Hospital of Guangzhou Military Command
OTHER
Guangzhou First People's Hospital
OTHER
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
OTHER
Southern Medical University, China
OTHER
Peking University People's Hospital
OTHER
Huazhong University of Science and Technology
OTHER
Sun Yat-sen University
OTHER
Academy Military Medical Science, China
INDUSTRY
Nanfang Hospital, Southern Medical University
OTHER
Responsible Party
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Qifa Liu
Professor
Principal Investigators
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Qifa Liu, MD
Role: PRINCIPAL_INVESTIGATOR
Nanfang Hospital, Southern Medical University
Locations
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Department of Hematology,Nanfang Hospital, Southern Medical University
Guangzhou, Guangdong, China
Countries
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Central Contacts
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Facility Contacts
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References
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Le Blanc K, Rasmusson I, Sundberg B, Gotherstrom C, Hassan M, Uzunel M, Ringden O. Treatment of severe acute graft-versus-host disease with third party haploidentical mesenchymal stem cells. Lancet. 2004 May 1;363(9419):1439-41. doi: 10.1016/S0140-6736(04)16104-7.
Perez-Simon JA, Lopez-Villar O, Andreu EJ, Rifon J, Muntion S, Diez Campelo M, Sanchez-Guijo FM, Martinez C, Valcarcel D, Canizo CD. Mesenchymal stem cells expanded in vitro with human serum for the treatment of acute and chronic graft-versus-host disease: results of a phase I/II clinical trial. Haematologica. 2011 Jul;96(7):1072-6. doi: 10.3324/haematol.2010.038356. Epub 2011 Mar 10.
Zhao K, Lin R, Fan Z, Li Z, Chen X, Xuan L, Huang F, Xu N, Wu X, Chen S, Sun J, Zhang X, Weng J, Li Y, Li Y, Lin D, Nie D, Wang S, Xu X, Zhang X, Li Y, Xiang AP, Wang Y, Liu Q. Reduced morbidity and mortality of cGVHD in patients who received treatment with mesenchymal stromal cells for steroid-resistant aGVHD: long-term follow-up of a randomized phase 3 trial. Exp Hematol Oncol. 2025 Jul 9;14(1):95. doi: 10.1186/s40164-025-00687-8.
Zhao K, Lin R, Fan Z, Chen X, Wang Y, Huang F, Xu N, Zhang X, Zhang X, Xuan L, Wang S, Lin D, Deng L, Nie D, Weng J, Li Y, Zhang X, Li Y, Xiang AP, Liu Q. Mesenchymal stromal cells plus basiliximab, calcineurin inhibitor as treatment of steroid-resistant acute graft-versus-host disease: a multicenter, randomized, phase 3, open-label trial. J Hematol Oncol. 2022 Mar 7;15(1):22. doi: 10.1186/s13045-022-01240-4.
Other Identifiers
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NFH-MSC-aGVHD-2014
Identifier Type: -
Identifier Source: org_study_id
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