Mesenchymal Stromal Cells for Acute Graft Versus Host Disease
This study is currently recruiting participants.
Verified November 2012 by Royal Perth Hospital
Sponsor:
R.P.Herrmann
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: November 27, 2012
Last verified: November 2012
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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:
Drug Information available for:
Prednisolone
Prednisolone acetate
Methylprednisolone acetate
Methylprednisolone
Prednisolone sodium phosphate
Prednisolone phosphate
Prednisolone sodium succinate
Methylprednisolone sodium succinate
U.S. FDA Resources
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:
|
| 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:
|
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01589549
Contacts
| Contact: Duncan Purtill, MB, BS | +61 8 92241165 | duncan.purtill@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: | Duncan Purtill, 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: | November 27, 2012 |
| 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 Neuroprotective Agents Protective Agents Glucocorticoids Hormones Hormones, Hormone Substitutes, and Hormone Antagonists Antineoplastic Agents, Hormonal Antineoplastic Agents |
ClinicalTrials.gov processed this record on May 23, 2013