UCBMSC Transplant + Locomotor Training for Spinal Cord Injury

No longer recruiting at 5 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: 7

Duration: 3-6 months

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new method to aid individuals with serious spinal cord injuries. It examines the effectiveness of transplanting special cells from umbilical cord blood (Umbilical Cord Blood Mononuclear Cell) combined with an intense walking program. The goal is to determine if this combination can enhance movement and strength in individuals with a stable spinal cord injury for at least a year. Suitable candidates have a complete spinal cord injury between specific spinal levels and can stand for at least an hour daily with assistance. As a Phase 2 trial, this research focuses on assessing the treatment's effectiveness in an initial, smaller group, providing an opportunity to contribute to significant advancements in spinal cord injury recovery.

Do I have to stop taking my current medications for the trial?

The trial information does not specify if you need to stop taking your current medications. It's best to discuss this with the trial team or your doctor.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that using cells from umbilical cord blood is generally safe. Studies have found that these cells can be administered without causing serious side effects. For example, trials have not reported major safety concerns, and participants did not experience severe complications, indicating that the treatment is well-tolerated.

Similarly, research on movement training for spinal cord injuries has shown it to be safe. While the main goal is to improve movement, no significant safety issues have been reported with this training. Participants in these sessions usually do not experience harmful effects.

Overall, these findings suggest that both umbilical cord blood cells and movement training are safe options for those considering joining this clinical trial. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about these treatments because they explore the use of umbilical cord blood mononuclear cells (UCBMNC) combined with locomotor training for spinal cord injury, which is quite different from standard therapies like physical rehabilitation or medications that primarily manage symptoms. UCBMNC are unique because they may promote nerve regeneration and repair due to their rich source of stem cells and growth factors. Additionally, the trial tests two approaches: one where UCBMNC transplantation occurs before locomotor training and another where it follows, allowing researchers to determine the optimal sequence for enhancing recovery. This combination could potentially offer a more effective way to restore movement and function in patients with spinal cord injuries.

What evidence suggests that this trial's treatments could be effective for spinal cord injury?

Research has shown that cells from umbilical cord blood can aid recovery from spinal cord injuries. These cells reduce damage such as tissue death, bleeding, and degeneration in the spinal cord. Animal studies demonstrated that these cells improve walking recovery, suggesting potential benefits for humans. In this trial, participants will receive either the umbilical cord blood mononuclear cell transplant followed by locomotor training or locomotor training followed by the transplant. Some studies indicate that movement training can aid functional recovery after a spinal cord injury, although results can vary. Combining these treatments might enhance recovery chances for individuals with long-term spinal cord injuries. ^{1 3 6 7 8}

Are You a Good Fit for This Trial?

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.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive UCBMNC (MC001) transplant and/or intensive locomotor training for 3-6 months

3-6 months

Daily sessions, 5±1 days a week

Follow-up

Participants are monitored for safety and effectiveness after treatment

48 weeks

Assessments at Week 2, 6, 28, and 48

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Citations

1.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC11848707

Locomotor training for walking after spinal cord injury - PMC

There is not enough evidence to conclude which locomotor training strategy is most effective in improving walking ability in people with spinal cord injury, or ...

2.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/18827681/

Locomotor training for walking after spinal cord injury

Overall, the results were inconclusive. There was no statistically significant effect of locomotor training on walking function after SCI ...

3.

clinicaltrials.gov

clinicaltrials.gov/study/NCT00006429

NCT00006429 | Treadmill Training for Spinal Cord Injury

The primary outcome measures are the level of independence for ambulation and the maximal speed for walking 50 feet. Patients will be tested by masked examiners ...

4.

sciencedirect.com

sciencedirect.com/science/article/abs/pii/S0074774219300686

The effects and potential mechanisms of locomotor training ...

A large numbers of clinical studies have proved the effectiveness of locomotor training on improvements in functional recovery after SCI. However, the outcomes ...

5.

jneuroengrehab.biomedcentral.com

jneuroengrehab.biomedcentral.com/articles/10.1186/s12984-023-01134-7

Cost-effectiveness analysis of overground robotic training ...

Overground robotic training was more effective and cost more than conventional training for people with complete SCI.

6.

mayoclinic.org

mayoclinic.org/tests-procedures/locomotor-training-for-spinal-cord-injury/about/pac-20394608

Locomotor training for spinal cord injury

Some studies have found that locomotor training for a spinal cord injury can lead to improvements in function. People with some feeling and ...

7.

sciencedirect.com

sciencedirect.com/science/article/abs/pii/S0003999317312856

Longitudinal Recovery and Reduced Costs After 120 ...

Delivering at least 120 sessions of LT improves recovery from incomplete chronic SCI. Because walking reduces rehospitalization, LT delivered beyond the average ...

8.

academic.oup.com

academic.oup.com/ptj/article/85/12/1356/2805094

Locomotor Training Progression and Outcomes After ...

Walking activity (X̄±SD) per 24 hours increased from 1,054±543 steps to 3,924±1,629 steps. Discussion. In a person with an incomplete SCI, ...