Stem Cells in Spinal Cord Injury
NCT03935724 · Status: UNKNOWN · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 16
Last updated 2023-09-29
Summary
This is a multicenter, randomized, double-blind, placebo-controlled and delayed-start phase II/III clinical study.
Conditions
- Spinal Cord Injuries
- Acute Spinal Cord Injury
- Paraplegia, Spinal
- Paraplegia; Traumatic
Interventions
- BIOLOGICAL
-
Neuro-Cells
Neuro-Cells is an autologous fresh stem cells containing product which modulates the secondary inflammation following a TSCI, reduces apoptosis (cell death) in the injured spinal cord, reduces scar tissue formation in the damaged spinal cord and creates a cell regenerative environment in the injured spinal cord.
Sponsors & Collaborators
-
Neuroplast
lead INDUSTRY
Principal Investigators
-
Antonio Oliviero, MD · Hospital Nacional de Parapléjicos de Toledo
-
Fin Biering-Soerensen, MD · Righospitalet
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- QUADRUPLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 65 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2022-01-18
- Primary Completion
- 2024-02-01
- Completion
- 2024-08-01
Countries
- Denmark
- Spain
Study Locations
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