Adipose Stem Cells for Traumatic Spinal Cord Injury
NCT03308565 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 10
Last updated 2022-08-30
Summary
The purpose of this study is to determine if mesenchymal stem cells (MSC) derived from the fat tissue can be safely administered into the cerebrospinal fluid (CSF) of patients with spinal cord injury. Adipose-derived mesenchymal stem cells (AD-MSCs) have been used in previous research studies at the Mayo Clinic. All subjects enrolled in this study will receive AD-MSC treatment, which is still experimental and is not approved by the U.S. Food and Drug Administration (FDA) for large scale use. However, the FDA has allowed the use of this agent in this research study.
Conditions
- Spinal Cord Injuries
- Paralysis
Interventions
- BIOLOGICAL
-
Autologous, Adipose derived Mesenchymal Stem Cells
The mesenchymal stem cells will be collected and expanded from the subjects adipose tissue.
Sponsors & Collaborators
-
Mohamad Bydon
lead OTHER
Principal Investigators
-
Mohamad Bydon, MD · Mayo Clinic, Rochester, MN
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2017-12-05
- Primary Completion
- 2019-10-22
- Completion
- 2021-10-11
- FDA Drug
- Yes
Countries
- United States
Study Locations
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