The utilization of mesenchymal stem cells (MSC) for the treatment of graft versus host disease (GVHD) after allogeneic stem cell transplantation.

Phase 1

• Conditions: The study is intended for patients after allogeneic hematopoietic stem cell transplantation (from related and unrelated donors) with steroid-refractory or steroid-dependent GVHD of any type: - Steroid refractory acute GVHD grade II-IV - Steroid refractory chronic GVHD - Steroid-dependent chronic late onset acute GVHD or overlap GVHD; Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]

• Registration Number: EUCTR2013-003626-88-CZ
• Lead Sponsor: Fakultní nemocnice Plzen

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2014-01-17
• Last Update Posted: 1 February 2020

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 25

Inclusion Criteria

Inclusion criteria for patients:
- Age 18-70 years
- A signed informed consent
- Status after allogeneic HSCT complicated with GVHD (any type) with effective levels of CsA (min 150 ng/ml) and:
a) no response to corticosteroids at a minimum dose of 1mg/kg administered for at least 2 weeks
or
b) GVHD progressing during the abovementioned treatment
or
c) corticosteroid-dependent GVHD , ie, GVHD responding to corticosteroids, but with the necessity of continuous administration of a minimum dose of 0.1 mg Medrol/kg/day (or equivalent)
or
d) GVHD permanently requiring combination of ciclosporin and another immunosuppressant (eg. MMF etc.), while steroids are from any reason contraindicated or not tolerated

Inclusion criteria for donors:
- A signed informed consent
- Negativity for infectious disease markers according to the standard requirements (SÚKL, JACIE, WMDA)
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 20
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 5

Exclusion Criteria

Exclusion criteria for patients:
- poor performance status with expected survival < week
- treatment with extracorporeal phohotopheresis (ECP) in less than 3 months
- active uncontrolled infection of any type
- the assumption of non-compliance
- activity (progression) of the primary disease

The exclusion criteria for donors:
- age> 65 years
- positive testing for infectious diseases markers

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified