Trials / Terminated
TerminatedNCT03979742
Umbilical Cord Blood Cell (MC001) Transplant Into Injured Spinal Cord Followed by the Locomotor Training
A Randomized Controlled Phase II, Two-Arm Study of Umbilical Cord Blood Cell Transplant (MC001) Into Injured Spinal Cord Followed by the Locomotor Training for Patients with Chronic Complete Spinal Cord Injuries (SCI).
- Status
- Terminated
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 6 (actual)
- Sponsor
- StemCyte, Inc. · Industry
- Sex
- All
- Age
- 18 Years – 60 Years
- Healthy volunteers
- Not accepted
Summary
Umbilical cord blood mononuclear stem cells (UCBMSCs) transplant followed by the intensive locomotor training for up to 5±1 hours a day, 5±1 days a week, and for 3-6 months for treatment in patients with chronic, stable and complete spinal cord injury.
Detailed description
This study is a randomized controlled, Phase II, two-arm study of Umbilical Cord Blood Mononuclear Cell (MC001) transplant into the injured spinal cord followed by the locomotor training for up to 5±1 hours a day, 5±1 days a week, for 3-6 months. A total of 18 subjects with chronic complete spinal cord injury (SCI) will be randomized to one of the two groups. The subjects assigned to Group A will receive 6.4 million UCBMNC (MC001) transplanted into the dorsal root entry zones above and below the injury site exposed by a laminectomy. Subjects in Group B will not have MC001 transplant or surgery. All subjects will receive 3-6 months of intensive locomotor training.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | Umbilical Cord Blood Mononuclear Cell | Active ingredients: Monocytes, CD34+, CD133+ cells Dose: 4 injections of 16-μliter (100,000 cells/μliter) |
| OTHER | Locomotor Training | Locomotor training for up to 6 hours a day, 6 days a week, and for 3-6 months |
Timeline
- Start date
- 2022-02-22
- Primary completion
- 2024-12-30
- Completion
- 2024-12-30
- First posted
- 2019-06-07
- Last updated
- 2025-02-28
Locations
2 sites across 1 country: Taiwan
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT03979742. Inclusion in this directory is not an endorsement.