Treatment of Chronic Graft-Versus-Host Disease With Mesenchymal Stromal Cells (MSC-cGvHD)

Guangdong Provincial People's Hospital (Guangdong Provincial Academy of Medical Sciences)

Status and phase: Unknown; Phase 3

Conditions: Chronic Graft-Versus-Host Disease

Treatments: Biological: Mesenchymal Stromal Cells

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT02291770

No.GRDEC 2014210H

Details and patient eligibility

About

Chronic Graft-versus-Host Disease (cGvHD) is a potentially lethal disorder. A variety of second line immunosuppressive agents have been investigated but no optimal treatment has emerged. There is therefore a need for novel treatment strategies. Mesenchymal stromal cells (MSC) exhibit immunomodulatory properties and a recent pilot study suggests a response rate of 70% in steroid- refractory patients. In the present randomized study the efficacy and safety of MSC treatment will be further studied in patients with cGvHD.

Enrollment: 130 estimated patients

Sex: All

Ages: 14 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Newly diagnosed cGvHD
• Informed consent obtained from patient and donor.
• Any patient who has undergone allogeneic stem cell transplantation with c GvHD.
• Have not received additional agent for cGVHD within 3 months.
• Expected life is more than 90 days.
• Adequate pulmonary function with no evidence of chronic obstructive or severe restrictive pulmonary disease.
• Adequate cardiac function with no evidence of uncontrolled high blood pressure,congestive heart failure, angina pectoris, acute myocardial infarction within 6 months prior to the process.

Exclusion criteria

• Invasive fungal disease.
• Active cytomegalovirus (CMV)/Epstein-Barr virus(EBV)/varicella disease).
• Patient is with a history of hypersensitivity to bovine products.
• Relapsed malignancy.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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130 participants in 2 patient groups, including a placebo group

Mesenchymal stem cells (MSC)

Active Comparator group

Description:

Patients with newly diagnosed cGvHD receive primary treatment plus MSC: 1. MSC+prednisone+cyclosporine; 2. MSC+prednisone+tacrolimus; 3. MSC+prednisone+mycophenolate mofetil.

Treatment:

Biological: Mesenchymal Stromal Cells

Placebo

Placebo Comparator group

Description:

Patients with newly diagnosed cGvHD receive primary treatment: 1. Placebo+prednisone+cyclosporine; 2. Placebo+prednisone+tacrolimus; 3. Placebo+prednisone+mycophenolate mofetil.