UCBMSC Transplant + Locomotor Training for Spinal Cord Injury

Recruiting at 4 trial locations

Overseen By Bobo Chen, PhD

Age: 18 - 65

Sex: Any

Trial Phase: Phase 2

Sponsor: StemCyte International, Ltd.

Disqualifiers: Renal, Cardiovascular, Hepatic, Psychiatric, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

6 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Eligibility Criteria

This trial is for adults aged 18-60 with chronic, complete spinal cord injury between C5 and T11 levels, stable for at least six months. Participants must be able to stand using support for an hour daily and have a matched umbilical cord blood unit available. Excluded are those with significant medical conditions, active infections near the implant site, immune deficiencies, or severe bone density loss.

Inclusion Criteria

I have complete loss of motor and sensory function below the injury level.

My spinal cord injury is between my neck and mid-back.

My partner and I agree to use birth control.

Exclusion Criteria

I do not have major health issues that could make surgery or intense physical training risky.

I do not have infections, severe spine deformity, immune issues, HIV, organ problems, depression, or low bone density.

I had a fracture in my leg or hip, but it's healed.

Treatment Details

Interventions

• Locomotor Training
• Umbilical Cord Blood Mononuclear Cell

Trial Overview The study tests transplanting umbilical cord blood cells into the injured spinal cord followed by intensive locomotor training (walking exercises) up to five hours a day for three to six months. The goal is to assess improvement in patients with stable and complete spinal injuries.

Participant Groups

Group I: MC001 before locomotor training Experimental Treatment 2 Interventions

Transplant UCBMNC (MC001) first and then perform locomotor training

Group II: Locomotor training before MC001 Experimental Treatment 2 Interventions

Locomotor training first and then transplant UCBMNC (MC001)

Who Is Running the Clinical Trial?

StemCyte International, Ltd.

Lead Sponsor

Trials

4

Recruited

90+

StemCyte, Inc.

Lead Sponsor

Trials

6

Recruited

110+

StemCyte Taiwan Co., Ltd.

Industry Sponsor

Trials

5

Recruited

90+