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This study is a randomized, placebo-controlled, phase 2a trial to study the biological activity, safety, and tolerability of regulatory T Lymphocytes (Tregs) taken and expanded outside of the body and returned back to the same person whose Treg were removed, given back by IV (intravenously) and in combination with low-dose IL-2 in people with Amyotrophic Lateral Sclerosis (ALS).
Based on data collected in a previous study with a small group of patients, evidence was found to show that interfering with the immune system using Treg cells slowed ALS disease progression. It is known that Treg cell numbers and function are reduced in patients with ALS and in some patients with lower Treg cells, they have a more marked rapid progression of their ALS. For this study, there are two sites (in Houston, TX and Boston, MA) in which Tregs will be taken from participants, increased or expanded outside the body, and then re-administered back to the participants from which the Tregs came.
This study has two parts:
1. the first period is a 6-month phase 2a, 2-center, randomized, placebo-controlled clinical trial studying the biological activity, safety, and tolerability of the increased / expanded Tregs administered intravenously (IV) with subcutaneous low-dose Interleukin-2 (IL-2) in 12 adults with ALS. IL2 helps regulate the immune system's white blood cells.
2. The second period is a 6-month open-label extension in which all participants will receive their own expanded Treg cells administered intravenously in combination with subcutaneous low-dose IL-2.
This study is studying whether the enhancement of Treg numbers and function will slow disease progression.
In the first study of Tregs, we completed a single-center, open-label phase I study of Tregs from people with ALS. Tregs were increased outside the body and returned back to the individual Treg owners in multiple doses every 2 to 4 weeks. This early study provided evidence in a small group of patients that treatment with autologous Tregs may be effective in slowing ALS progression.
ALS (Amyotrophic Lateral Sclerosis)
Monthly autologous Treg cells infusions + 3 times per week Interleukin-2 injections, Monthly placebo infusions + 3 times per week placebo injections, Monthly autologous Treg cells infusions + 3 times per week Interleukin-2 injections
Massachusetts General Hospital (MGH) Neurological Clinical Research Institute
Not yet recruiting
The Methodist Hospital System
Published on BioPortfolio: 2019-08-19T19:46:45-0400
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