Mesenchymal Stem Cell Therapy in Multiple System Atrophy …

Posted: July 2, 2016 at 2:46 pm

This post was added by Dr. Richardson

Describes the nature of a clinical study. Types include:

During the early phases (phases 1 and 2), researchers assess safety, side effects, optimal dosages and risks/benefits. In the later phase (phase 3), researchers study whether the treatment works better than the current standard therapy. They also compare the safety of the new treatment with that of current treatments. Phase 3 trials include large numbers of people to make sure that the result is valid. There are also less common very early (phase 0) and later (phase 4) phases. Phase 0 trials are small trials that help researchers decide if a new agent should be tested in a phase 1 trial. Phase 4 trials look at long-term safety and effectiveness, after a new treatment has been approved and is on the market.

Site IRB

NCT ID: NCT02315027

Sponsor Protocol Number: 12-005950

The purpose of this study is to determine whether mesenchymal stem cells (MSCs) can be safely delivered to the cerebrospinal fluid (CSF) of patients with multiple system atrophy (MSA).

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. If you need assistance understanding the eligibility criteria, please contact the study team.

Inclusion Criteria

Exclusion Criteria

Any of the following conditions will exclude the participant from entering the study:

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Mesenchymal Stem Cell Therapy in Multiple System Atrophy ...

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