Mesenchymal Stromal Cells for Acute Graft Versus Host Disease

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2014 by Royal Perth Hospital
Sponsor:
Collaborator:
Royal Perth Hospital
Information provided by (Responsible Party):
R.P.Herrmann, Royal Perth Hospital
ClinicalTrials.gov Identifier:
NCT01589549
First received: April 26, 2012
Last updated: July 23, 2014
Last verified: July 2014
  Purpose

A randomised study of corticosteroid therapy with or without mesenchymal stromal cell therapy for newly diagnosed acute graft versus host disease after bone marrow transplantation or donor lymphocyte therapy.

It is hypothesised that mesenchymal stromal cell therapy will be superior


Condition Intervention Phase
Acute GVH Disease
Biological: Mesenchymal stromal cell therapy
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase 2 Trial of Standard of Care Treatment Versus Mesenchymal Stromal Cell Therapy Together With Standard of Care for the Treatment of de Novo Acute Graft Versus Host Disease Following Allogeneic Bone Marrow Transplantation

Resource links provided by NLM:


Further study details as provided by Royal Perth Hospital:

Primary Outcome Measures:
  • Survival at one year after onset of graft versus host disease [ Time Frame: One year ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Response at 14 days after commencement of treatment for acute graft versus host disease [ Time Frame: 14 days ] [ Designated as safety issue: No ]
  • Response at 28 days after commencement of treatment of acute graft versus host disease [ Time Frame: 28 days ] [ Designated as safety issue: No ]
  • Incidence of severe infection [ Time Frame: One year ] [ Designated as safety issue: Yes ]
  • Disease free survival at one year [ Time Frame: One year ] [ Designated as safety issue: Yes ]
  • Time to treatment failure, requiring salvage therapy [ Time Frame: 28 days ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 66
Study Start Date: April 2012
Estimated Study Completion Date: December 2016
Estimated Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Mesenchymal stromal cell therapy
Mesenchymal stromal cell therapy in addition to corticosteroid therapy
Biological: Mesenchymal stromal cell therapy
One arm will be randomised to receive mesenchymal stromal cell therapy in addition to corticosteroid therapy
Other Names:
  • Methylprednisolone
  • Mesenchymal stem cells
Active Comparator: Corticosteroid therapy Biological: Mesenchymal stromal cell therapy
One arm will be randomised to receive mesenchymal stromal cell therapy in addition to corticosteroid therapy
Other Names:
  • Methylprednisolone
  • Mesenchymal stem cells

Detailed Description:

Patients with newly diagnosed untreated acute graft versus host disease grades 2-4 will receive methylprednisolone 2.5mg/kg intravenously and randomised to receive or not receive allogeneic human mesenchymal stromal cells 2X10E6 intravenously on two occasions at weekly intervals

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Grades 2-4 acute graft versus host disease after bone marrow transplantation up to day +180 after transplantation
  • Age 18-55 years

    • Must be receiving a calcineurin inhibitor

Exclusion Criteria:

  • Failure to sign informed consent
  • Corticosteroid therapy for 72 hours or greater
  • ECOG score equal to or greater than 3
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01589549

Contacts
Contact: Julian Cooney, MB, BS +61 8 92241165 julian.cooney@health.gov.au
Contact: Richard Herrmann, MB, BS +61 8 92241165 richard.herrmann@health.wa.gov.au

Locations
Australia, Western Australia
Royal Perth Hospital Recruiting
Perth, Western Australia, Australia, 6000
Contact: Megan Margaria, BN    +61 8 92247038    megan.margaria@health.wa.gov.au   
Sponsors and Collaborators
R.P.Herrmann
Royal Perth Hospital
Investigators
Principal Investigator: Julian Cooney, MB, BS Royal Perth Hospital
  More Information

No publications provided

Responsible Party: R.P.Herrmann, Director, Cell and Tissue Therapies, Royal Perth Hospital, Royal Perth Hospital
ClinicalTrials.gov Identifier: NCT01589549     History of Changes
Other Study ID Numbers: 2011/128, CTN 2012/0174
Study First Received: April 26, 2012
Last Updated: July 23, 2014
Health Authority: Australia: Department of Health and Ageing Therapeutic Goods Administration

Keywords provided by Royal Perth Hospital:
Acute graft versus host disease
Bone marrow transplantation
Mesenchymal stromal cells

Additional relevant MeSH terms:
Graft vs Host Disease
Immune System Diseases
Methylprednisolone acetate
Prednisolone acetate
Methylprednisolone
Methylprednisolone Hemisuccinate
Prednisolone
Prednisolone hemisuccinate
Prednisolone phosphate
Anti-Inflammatory Agents
Therapeutic Uses
Pharmacologic Actions
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Central Nervous System Agents
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Neuroprotective Agents
Protective Agents
Antineoplastic Agents, Hormonal
Antineoplastic Agents

ClinicalTrials.gov processed this record on August 28, 2014