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Mesenchymal Stromal Cells as Treatment of Chronic Graft-versus-host Disease

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ClinicalTrials.gov Identifier: NCT01522716
Recruitment Status : Terminated (New requirements for study approval with the Swedish Medical Products Agency)
First Posted : February 1, 2012
Last Update Posted : November 25, 2020
Sponsor:
Collaborator:
Stockholm County Council, Sweden
Information provided by (Responsible Party):
Lena von Bahr, Karolinska Institutet

Tracking Information
First Submitted Date  ICMJE January 24, 2012
First Posted Date  ICMJE February 1, 2012
Last Update Posted Date November 25, 2020
Study Start Date  ICMJE August 2011
Actual Primary Completion Date March 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 23, 2020)
Change in disease activity according to National Institute of Health criteria [ Time Frame: Baseline to 9 months ]
Patients are evaluated according to NIH criteria at 3, 6 and (if applicable) 9 months after initialising MSC treatment, and the score compared to baseline score.
Original Primary Outcome Measures  ICMJE
 (submitted: January 27, 2012)
Change in disease activity according to National Institute of Health criteria [ Time Frame: Baseline to 9 months ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: November 23, 2020)
  • Change in disease activity as measured by histological examination [ Time Frame: Baseline to 9 months ]
  • Change in self-assessed disease activity and quality of life [ Time Frame: Baseline to 9 months ]
  • Safety (Adverse events, infections and relapse) [ Time Frame: 21 months ]
    Frequency of complications, infections and relapse
  • Freedom from steroids at 1 year after MSC treatment [ Time Frame: 1 year after finishing treatment ]
    Proportion of patients free from corticosteroids at 1 year after finishing MSC treatment.
Original Secondary Outcome Measures  ICMJE
 (submitted: January 27, 2012)
  • Change in disease activity as measured by histological examination [ Time Frame: Baseline to 9 months ]
  • Change in self-assessed disease activity and quality of life [ Time Frame: Baseline to 9 months ]
  • Safety [ Time Frame: 21 months ]
    Frequency of complications, infections and relapse
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Mesenchymal Stromal Cells as Treatment of Chronic Graft-versus-host Disease
Official Title  ICMJE Mesenchymal Stromal Cells as Treatment of Chronic Graft-versus-host Disease
Brief Summary The aim of the study is to evaluate the safety and efficacy of mesenchymal stromal cells as treatment for steroid-refractory chronic graft-versus-host disease.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Graft-Versus-Host Disease
Intervention  ICMJE Biological: Mesenchymal stromal cells
Allogenous mesenchymal stromal cells, to be injected intravenously at a dose of 1-2 million/kg at a frequency of once a month (frequency may be changed during the study if deemed appropriate by investigators) for 6-9 months.
Study Arms  ICMJE Experimental: Mesenchymal stromal cell treatment
Intervention: Biological: Mesenchymal stromal cells
Publications * Boberg E, von Bahr L, Afram G, Lindström C, Ljungman P, Heldring N, Petzelbauer P, Garming Legert K, Kadri N, Le Blanc K. Treatment of chronic GvHD with mesenchymal stromal cells induces durable responses: A phase II study. Stem Cells Transl Med. 2020 Oct;9(10):1190-1202. doi: 10.1002/sctm.20-0099. Epub 2020 Jun 23.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: February 23, 2016)
11
Original Estimated Enrollment  ICMJE
 (submitted: January 27, 2012)
10
Actual Study Completion Date  ICMJE March 2017
Actual Primary Completion Date March 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Chronic graft-versus-host disease, grade moderate or severe despite at least 3 months treatment with calcineurin inhibitors and steroids OR
  • Chronic graft-versus-host disease, grade moderate or severe, where full treatment with calcineurin inhibitors and steroids is impossible due to intolerable side-effects

Exclusion Criteria:

  • Active malignancy
  • Fulfilling criteria for previously initiated study for treatment of chronic graft-versus-host disease
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Sweden
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01522716
Other Study ID Numbers  ICMJE MSC-cGVH
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Lena von Bahr, Karolinska Institutet
Study Sponsor  ICMJE Karolinska Institutet
Collaborators  ICMJE Stockholm County Council, Sweden
Investigators  ICMJE Not Provided
PRS Account Karolinska Institutet
Verification Date November 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP