Clinical Trials Logo
  1. Home
  2. Graft Versus Host Disease
  3. NCT01522716
  4. Details
NCT01522716 Clinical Trial

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

Graft-Versus-Host Disease Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data
NCT number NCT01522716
Other study ID # MSC-cGVH
Secondary ID
Status Terminated
Phase Phase 1
First received
Last updated
Start date August 2011
Est. completion date March 2017

Study information
Verified date November 2020
Source Karolinska Institutet
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Terminated
Enrollment 11
Est. completion date March 2017
Est. primary completion date March 2016
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

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.

Locations
Country Name City State
Sweden Hematology Center, Karolinska University Hospital Huddinge Stockholm

Sponsors (2)
Lead Sponsor Collaborator
Karolinska Institutet Stockholm County Council, Sweden

Country where clinical trial is conducted

Sweden, 

Outcome
Type Measure Description Time frame Safety issue
Primary Change in disease activity according to National Institute of Health criteria 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. Baseline to 9 months
Secondary Change in disease activity as measured by histological examination Baseline to 9 months
Secondary Change in self-assessed disease activity and quality of life Baseline to 9 months
Secondary Safety (Adverse events, infections and relapse) Frequency of complications, infections and relapse 21 months
Secondary Freedom from steroids at 1 year after MSC treatment Proportion of patients free from corticosteroids at 1 year after finishing MSC treatment. 1 year after finishing treatment
See also
  Status Clinical Trial Phase
Active, not recruiting NCT01428973 - Minitransplants With HLA-matched Donors : Comparison Between 2 GVHD Prophylaxis Regimens Phase 2
Not yet recruiting NCT00749164 - Allogeneic Mesenchymal Stem Cell for Graft-Versus-Host Disease Treatment Phase 1/Phase 2
Completed NCT00993343 - Randomized Trial Comparing Sirolimus and Tacrolimus Versus Cyclosporine and Methotrexate as Graft-versus-host Disease (GVHD) Prophylaxis After Allogeneic Stem Cell Transplantation Phase 3
Completed NCT00360685 - Tacrolimus and Mycophenolate Mofetil (MMF) in GVHD Prophylactic Regimen Compared to Tacrolimus and Methotrexate (MTX N/A
Active, not recruiting NCT04503616 - Cyclophosphamide, Abatacept, and Tacrolimus for GvHD Prevention Phase 1/Phase 2
Terminated NCT02080195 - Nonmyeloablative Conditioning and Transplantation for Patients With Refractory Systemic Lupus Erythematosus (SLE) Phase 1/Phase 2
Completed NCT02193880 - Safety of Post-transplant Alpha-beta Depleted T-cell Infusion Following Haploidentical Stem Cell Transplant (Haplo SCT) N/A
Completed NCT02942173 - CD45RA Depleted T-cell Infusion for Prevention of Infections After TCRab/CD19-depleted Allo-HSCT Phase 2/Phase 3
Completed NCT02145403 - Phase 1/2 Study of Carfilzomib for the Prevention of Relapse and GVHD in Allo-HCT for Hematologic Malignancies Phase 1/Phase 2
Recruiting NCT01941394 - Mesenchymal Stem Cells Infusion for aGVHD Prophylaxis Transplantation Phase 2
Completed NCT00141713 - The Use of Etanercept (Enbrel®) in the Treatment of Acute Graft-Versus-Host Disease Phase 2
Recruiting NCT01991301 - Carfilzomib for the Prevention of Graft Versus Host Disease Phase 1
Completed NCT00408928 - Study on the Safety and Effectiveness of VELCADE® in the Treatment of Graft-Versus-Host Disease Phase 2
Completed NCT01633229 - Bone Marrow Stromal Cell Infusions for Stem Cell Transplant Complications Phase 1
Completed NCT05856058 - To Assess SHR0302 Oral Solutions and Tablets in Healthy Subjects Clinical Studies of Relative Bioavailability Phase 1
Completed NCT02342613 - Adoptive Immunotherapy With Activated Marrow Infiltrating Lymphocytes and Cyclophosphamide Graft-Versus-Host Disease Prophylaxis in Patients With Relapse of Hematologic Malignancies After Allogeneic Hematopoietic Cell Transplantation Phase 1
Recruiting NCT06423131 - Prospective Clinical Trial for Children With TCRαβ Depleted vs Traditional Haplo Identicle HSCT N/A
Completed NCT02144025 - Prevention of Ocular Graft-Versus-Host Disease With Topical Cyclosporine in Recipients of Allogeneic HSCT Phase 2
Completed NCT01369914 - The Natural History of Graft-Versus-Host Disease in the Eyes
Completed NCT00806728 - Study of MEDI-507 in With Steroid-Resistant Acute Graft-Versus-Host Disease Phase 1