Mesenchymal Stromal Cells to Treat Steroid-refractory Graft Versus Host Disease after Bone Marrow Transplantation

A phase 1 study to assess the safety of mesenchymal stromal cells to treat steroid-refractory graft versus host disease after allogeneic haemopoietic stem cell tranplantation.

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12610000068066

Enrollment

Registered

2010-01-20

Start date

2007-12-01

Completion date

Unknown

Last updated

2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

Study hypothesis is that mesenchymal cells are safe and will be effective in treating steroid refractory graft versus host disease. Trial subjects will receive 2 X 10 E6/kg mesenchymal cells weekly for 2 weeks, are then reassessed weekly. If inadequate response may receive two further doses at weekly intervals. May be retreated if they subsequently relapse

Interventions

Mesenchymal stromal cells 2 X 10E6/kg administered intrvenously over 15 minutes weekly for two weeks

Study design

Allocation

Non-randomised trial

Intervention model

Single group

Primary purpose

Treatment

Masking

Open (masking not used)

Eligibility

Sex/Gender

All

Age

18 Years to 60 Years

Healthy volunteers

Inclusion criteria

Age 18-60 Steroid-refractory graft versus host disease post allogeneic haemopoietic stem cell transplant Informed consent given

Exclusion criteria

No informed consent

Outcome results