Allogeneic Bone Marrow-Derived Mesenchymal Stem Cell Therapy for Idiopathic Parkinson's Disease
NCT02611167 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 20
Last updated 2023-11-29
Summary
The purpose of this study is to assess the safety, feasibility, and efficacy of intravenous allogeneic bone marrow-derived mesenchymal stem cell (MSC) therapy for idiopathic Parkinson's disease (iPD).
Conditions
Interventions
- BIOLOGICAL
-
Allogeneic bone marrow-derived MSCs (1 x 10 6 MSC/kg)
Bone marrow-derived allogeneic MSCs will be delivered intravenously in escalating doses of 1 x 10 6 MSC/kg, 3 x 10 6 MSC/kg, 6 x 10 6 MSC/kg, or 10 x 10 6 MSC/kg of body weight to a population of patients with idiopathic Parkinson's disease (iPD).
- BIOLOGICAL
-
Allogeneic bone marrow-derived MSCs (3 x 10 6 MSC/kg)
Bone marrow-derived allogeneic MSCs will be delivered intravenously in escalating doses of 1 x 10 6 MSC/kg, 3 x 10 6 MSC/kg, 6 x 10 6 MSC/kg, or 10 x 10 6 MSC/kg of body weight to a population of patients with idiopathic Parkinson's disease (iPD).
- BIOLOGICAL
-
Allogeneic bone marrow-derived MSCs (6 x 10 6 MSC/kg)
Bone marrow-derived allogeneic MSCs will be delivered intravenously in escalating doses of 1 x 10 6 MSC/kg, 3 x 10 6 MSC/kg, 6 x 10 6 MSC/kg, or 10 x 10 6 MSC/kg of body weight to a population of patients with idiopathic Parkinson's disease (iPD).
- BIOLOGICAL
-
Allogeneic bone marrow-derived MSCs (10 x 10 6 MSC/kg)
Bone marrow-derived allogeneic MSCs will be delivered intravenously in escalating doses of 1 x 10 6 MSC/kg, 3 x 10 6 MSC/kg, 6 x 10 6 MSC/kg, or 10 x 10 6 MSC/kg of body weight to a population of patients with idiopathic Parkinson's disease (iPD).
Sponsors & Collaborators
-
The University of Texas Health Science Center, Houston
lead OTHER
Principal Investigators
-
Mya Schiess, MD · The University of Texas Health Science Center, Houston
Study Design
- Allocation
- NON_RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SEQUENTIAL
Eligibility
- Min Age
- 45 Years
- Max Age
- 70 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2017-11-01
- Primary Completion
- 2019-09-18
- Completion
- 2019-09-18
- FDA Drug
- Yes
Countries
- United States
Study Locations
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