Fecal Microbiota Transplantation After Autologous HSCT in Patients With Multiple Sclerosis
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- STATUS
- Recruiting
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- End date
- Dec 1, 2024
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- participants needed
- 20
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- sponsor
- St. Petersburg State Pavlov Medical University
Summary
The hypothesis of the study is that according to modern data, the pathogenesis of multiple sclerosis is inextricably linked to the patient's microbiota. Therefore, transplantation of a normal fecal microbiota (FMT) can improve the outcome of autologous hematopoietic stem cell transplantation (autoHSCT) by increasing the disease-free period and disease progression suspension for at least 5 years after transplantation, which meets the NEDA (No Evidence of Disease Activity) criteria, satisfying the current trends of clinical neurology.
Description
AutoHSCT may be a method of choice to treat patients with refractory forms of multiple sclerosis, taking into account the insufficient efficacy of first line therapy, lack of availability (government approval) and high cost of monoclonal antibodies as a second line drugs. In this setting, according to the safety-efficiency ratio the most appropriate are reduced intensity conditioning regimens in autoHSCT. In 75% of cases for refractory forms of multiple sclerosis it is possible to achieve 5 years remission with transplant mortality less than 1%. In recent years, it is quite clear that gut microbiota abnormalities may be one of mechanisms for autoimmune diseases development. Therefore, the correction of gut dysbiosis through FMT from a healthy donor can improve the effectiveness of basic therapies. Currently, FMT is a rapidly developing method of treating intestinal infections associated with multi-resistant bacteria, based on the replacement of the recipient's microbiota by the donor's microbiota.
Details
| Condition | Multiple Sclerosis |
|---|---|
| Treatment | allogeneic fecal microbiota |
| Clinical Study Identifier | NCT04203017 |
| Sponsor | St. Petersburg State Pavlov Medical University |
| Last Modified on | 4 October 2022 |
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