Safety and Efficacy Study of Adult Human Mesenchymal Stem Cells to Treat Acute Graft Versus Host Disease (GVHD)
NCT ID: NCT00136903
Last Updated: 2022-01-31
Study Results
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Basic Information
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COMPLETED
PHASE2
32 participants
INTERVENTIONAL
2005-04-27
2008-07-14
Brief Summary
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Detailed Description
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Protocol 261- This study is designed as a long-term safety follow-up of participants who take part in the preceding clinical study of Prochymal® (Protocol 260) for the treatment of acute GVHD. Participants will be enrolled in Study 261 upon completion of the preceding Study 260.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Prochymal® - 2 Million cells/kg
Participants will receive Prochymal® consisting of 2 million hMSCs/kg actual body weight, intravenously (IV) on Days 1 and 4 along with daily standard of care which includes methylprednisolone 2 milligrams (mg)/kg IV or prednisone 2.5 mg/kg orally. Participants will also continue cyclosporine, tacrolimus, and/or mycophenolate mofetil (MMF) at full therapeutic doses.
Prochymal® - 2 Million cells/kg
2 million hMSCs/kg actual body weight, IV on study Days 1 and 4
Methylprednisolone
Methylprednisolone 2 mg/kg administered intravenously.
Prednisone
Prednisone 2.5 mg/kg administered orally.
Cyclosporine
Administered as prescribed by the caregiver.
Tacrolimus
Administered as prescribed by the caregiver.
Mycophenolate Mofetil
Administered as prescribed by the caregiver.
Prochymal® - 8 Million cells/kg
Participants will receive Prochymal® consisting of 8 million hMSCs/kg actual body weight IV on Days 1 and 4 along with daily standard of care which includes methylprednisolone 2 mg/kg IV or prednisone 2.5 mg/kg orally. Participants will also continue cyclosporine, tacrolimus, and/or mycophenolate mofetil (MMF) at full therapeutic doses.
Prochymal®- 8 Million cells/kg
8 million hMSCs/kg actual body weight IV on study Days 1 and 4
Methylprednisolone
Methylprednisolone 2 mg/kg administered intravenously.
Prednisone
Prednisone 2.5 mg/kg administered orally.
Cyclosporine
Administered as prescribed by the caregiver.
Tacrolimus
Administered as prescribed by the caregiver.
Mycophenolate Mofetil
Administered as prescribed by the caregiver.
Interventions
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Prochymal® - 2 Million cells/kg
2 million hMSCs/kg actual body weight, IV on study Days 1 and 4
Prochymal®- 8 Million cells/kg
8 million hMSCs/kg actual body weight IV on study Days 1 and 4
Methylprednisolone
Methylprednisolone 2 mg/kg administered intravenously.
Prednisone
Prednisone 2.5 mg/kg administered orally.
Cyclosporine
Administered as prescribed by the caregiver.
Tacrolimus
Administered as prescribed by the caregiver.
Mycophenolate Mofetil
Administered as prescribed by the caregiver.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* If female and of child-bearing age, participant must be non-pregnant, not breast feeding, and use adequate contraception. Males must use adequate contraception.
* Participant must have newly diagnosed, Grade II-IV acute GVHD requiring therapy. Biopsy for confirmation of GVHD is not mandatory, but is recommended when feasible. Enrollment should not be delayed awaiting biopsy results.
* Participant must have received either full or reduced intensity myeloablative regimens followed by an allogeneic hematopoietic stem cell transplant using bone marrow, peripheral blood stem cell, or cord blood, including donor lymphocyte infusion (DLI).
* Participant must have minimal renal and hepatic function as defined by:
\* Calculated creatinine clearance (CLcr) of \> 30 mL/min using the Cockroft-Gault equation.
* Participant must be available for all specified assessments at the study site through study Day 28.
* Participant must provide written informed consent and authorization for use and disclosure of protected health information (PHI).
Exclusion Criteria
* Participant has been treated for GVHD with methylprednisolone, \> 2mg/kg/day, for more than 72 hours prior to receiving Prochymal®.
* Participant has uncontrolled alcohol or substance abuse within 6 months of randomization.
* Participant has received an investigational agent (not approved by food and drug administration (FDA) for marketed use in any indication) within 30 days of randomization. Participant may not receive an investigational agent during the 28-day study period.
* Participant has any underlying or current medical or psychiatric condition that, in the opinion of the Investigator, would interfere with the evaluation of the participant (e.g., uncontrolled infection, right heart failure, pulmonary hypertension, etc.).
* Participant has unstable arrhythmia.
* Participant is unwilling to sign consent form for the long-term follow-up study, Protocol 261.
* Participant has a known allergy to bovine or porcine products.
* Participant had received transplant for a solid tumor disease.
18 Years
70 Years
ALL
No
Sponsors
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Mesoblast, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Christopher James, PA
Role: STUDY_DIRECTOR
Mesoblast, Inc.
Locations
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St. Francis Hospital
Indianapolis, Indiana, United States
Kansas City Cancer Centers - BMT
Kansas City, Missouri, United States
The Cancer Center at Hackensack University
Hackensack, New Jersey, United States
Roswell Park Cancer Institute
Buffalo, New York, United States
Mt. Sinai Hospital
New York, New York, United States
University of Rochester
Rochester, New York, United States
New York Medical College
Valhalla, New York, United States
MD Anderson Cancer Center
Houston, Texas, United States
Medical College of Wisconsin, FEC
Milwaukee, Wisconsin, United States
Countries
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References
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Bartholomew A, Sturgeon C, Siatskas M, Ferrer K, McIntosh K, Patil S, Hardy W, Devine S, Ucker D, Deans R, Moseley A, Hoffman R. Mesenchymal stem cells suppress lymphocyte proliferation in vitro and prolong skin graft survival in vivo. Exp Hematol. 2002 Jan;30(1):42-8. doi: 10.1016/s0301-472x(01)00769-x.
Deans RJ, Moseley AB. Mesenchymal stem cells: biology and potential clinical uses. Exp Hematol. 2000 Aug;28(8):875-84. doi: 10.1016/s0301-472x(00)00482-3.
Lazarus HM, Koc ON, Devine SM, Curtin P, Maziarz RT, Holland HK, Shpall EJ, McCarthy P, Atkinson K, Cooper BW, Gerson SL, Laughlin MJ, Loberiza FR Jr, Moseley AB, Bacigalupo A. Cotransplantation of HLA-identical sibling culture-expanded mesenchymal stem cells and hematopoietic stem cells in hematologic malignancy patients. Biol Blood Marrow Transplant. 2005 May;11(5):389-98. doi: 10.1016/j.bbmt.2005.02.001.
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.
Le Blanc K, Pittenger M. Mesenchymal stem cells: progress toward promise. Cytotherapy. 2005;7(1):36-45. doi: 10.1080/14653240510018118.
Kebriaei P, Isola L, Bahceci E, Holland K, Rowley S, McGuirk J, Devetten M, Jansen J, Herzig R, Schuster M, Monroy R, Uberti J. Adult human mesenchymal stem cells added to corticosteroid therapy for the treatment of acute graft-versus-host disease. Biol Blood Marrow Transplant. 2009 Jul;15(7):804-11. doi: 10.1016/j.bbmt.2008.03.012.
Related Links
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Click here for more information on Prochymal® for treatment of GVHD
Other Identifiers
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260-261
Identifier Type: -
Identifier Source: org_study_id
NCT00476762
Identifier Type: -
Identifier Source: nct_alias
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