Clinical Trials

A single centre phase II study of autologous haematopoietic stem cell transplant (AHSCT) for severe autoimmune diseases

Type of Study/Intervention

Medical Procedure

Recruitment Status

Recruiting

Form of MS

Secondary progressive MS; primary progressive MS

Brief summary

This trial is testing autologous (self) haematopoeitc stem cells transplant for a variety of severe autoimmune diseases, including multiple sclerosis.

The treatment involves: treatment and collection and freezing of stem cells from the patient’s blood; chemotherapy (BEAM-ATG) to destroy the immune system; reinfusion of the patient’s own stem cells.

Full details of the treatment protocol can be found here in the Australian New Zealand Clinical Trials Registry.

Eligibility criteria

General eligibility criteria must be met for all patients entering the trial. This inlcudes general health criteria relating to cardiovcascular, lung and liver health, absence of serious infections diseases, negative pregnancy test for women, age between 18 and 65 years and ability to provide informed consent. Specific eligibility criteria must also be met for each disease type. For multiple sclerosis the eligibiligy criteria are as follows:

MS clinically defined and supported by laboratory tests (eg:MRI). Patients should have an EDSS between 3.5 and 6.5 at screening evaluation and the presence of one or more gadolinium enhancing lesion on MRI. Previous Treatment with Nataluzimab is allowed but a minimum of 3 months MUST have elapsed since completion of treatment. The forms of MS eligible for the trial are:

  • Secondary Progressive form of MS with or without relapses, with recent worsening of disease in the previous year despite immunomodulating therapy (interferon beta or glatimer acetate) and/or immunosuppressive therapy
  • Relapsing remitting form of MS with recent worsening of disease or accumulation of disability in the previous year despite immunomodulating therapy (interferon beta or glatimer acetate) and/or immunosuppressive therapy
  • Relapsing-remitting forms of MS who do not accumulate disability but who have at least two relapses per year, in spite of immunomodulating therapy (interferon beta or glatiramer acetate, where approved) or immunomodulating and immunosuppressive therapy and presence of one or more enhancing areas at MRI (possible repetition of MRI within three months)
  • Secondary progressive form of MS with or without relapses or relapsing-remitting MS form who accumulate disability between relapses (relapsing-progressive) with a worsening documented by EDSS during the last year in spite of the immunomodulating therapy (interferon beta or glatiramer acetate, where approved) or immunomodulating and immunosuppressive therapy, even in the absence of contrast enhancing areas at MRI.

For full details of inclusion and exclusion criteria please visit the ANZCTR trial listing.

A similar study is also running in Melbourne.

For more background information about AHSCT for MS please visit the MS Research Australia website www.msra.org.au/AHSCT.

Exclusion criteria

A full list of exclusion criteria can be found on the ANZCTR clinical trials database.

Anticipated start date

Started

Recruitment contacts

Dr John Moore
St Vincent’s Hospital, Sydney
390 Victoria St, Darlinghurst NSW 2010, Australia
Email: [email protected]
Phone: 02 9355 5656
Fax: 02 9355 5735

Further details

For further details visit the ANZCTR trial listing.

Region

NSW

Last updated

April 2016

Trial number

ACTRN12613000339752

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