Umbilical Cord Blood Cell Transplant Into Injured Spinal Cord With Lithium Carbonate or Placebo Followed by Locomotor Training

• Status: Not yet recruiting
• Trial end date: 2023-02-01
• Target enrollment: 0
• Participant gender: All

Summary

Umbilical cord blood mononuclear stem cells (UCBMSCs) transplant in combination with 6-week course of oral lithium carbonate (Li2CO3) followed by the intensive locomotor training for up to 6 hours a day, 6 days a week, and for 3-6 months for treatment in patients with chronic, stable and complete spinal cord injury.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: StemCyte, Inc.
• Collaborator: Amarex Clinical Research
• Treatments: Lithium Carbonate

Criteria

Inclusion Criteria:

• Male and female subjects' ≥18 to ≤60 years.

• Traumatic SCI at a neurological level (the lowest contiguous spinal cord segmental level that has intact motor and sensory score) between C5 and T11.

Note: For the first three subjects at each study center, the neurological level of SCI will be limited to thoracic region (between T1 and T11).

• Subjects with chronic SCI (defined as ≥ 12 months post- initial SCI surgery) with stable neurologic findings for at least six months and be able stand at least 1 hour/day using a standing frame, tilt table, or equivalent device.

• Subjects with a current neurological status of ASIA impairment grade A (complete).

• The injured site of the spinal cord is within three vertebral levels as confirmed by MRI scan.

• Subject must be in good enough physical health to tolerate the surgery and participate in the intensive walking program.

• Clinically normal resting 12-lead ECG at Screening Visit or, if abnormal, considered not clinically significant by the Principal Investigator.

• Both male and female subjects and their partners of childbearing potential must agree to use medically accepted methods of contraception.

• Willing and able to participate in all aspects of the study, including completion of subjective evaluations, attendance at scheduled clinic visits, and compliance with all protocol requirements as evidenced by providing written informed consent.

Exclusion Criteria:

• Clinically significant renal, cardiovascular, hepatic and psychiatric diseases or other conditions that may increase risk of complications during or after surgery or may reduce the ability of the patient to participate in intense locomotor training based on the medical judgment of the investigator.

• Presence of any clinically significant medical condition(s) or infection (including but not limited to the carrier of hepatitis B virus or HIV) that, in the opinion of the Investigator, could interfere with the treatment or participation in the study.

• Subjects with flaccid paralysis with absence of deep tendon reflexes in the legs, severe atrophy of the lower limbs, or other evidence of lumbosacral injury, peripheral nerve injury, and motoneuronal loss.

• Fracture of weight-bearing bones and joints. These include fractures of femur, tibia, and fibula, as well as the ankle, knee, or hip joints. If such fractures have healed, the patient can be included in the trial.

• Injury to brain, peripheral nerve, or muscle that may interfere with neurologic or walking assessment.

• Pregnant or lactating woman.

• Syringomyelic cyst >30% of the cord diameter.

• Unavailability of HLA-matched umbilical cord blood cells.

• Current or recent (within 1 month) treatment with lithium.

• Any contraindication of laminectomy operation, lithium carbonate therapy or locomotor training.

• Taking medication that may interfere with lithium clearance, such as diuretics, NSAIDs (except acetoaminophen or Tylenol), nitroimidazole antibiotics or medications that has clinically important interactions with lithium.

• Subjects with abnormal renal function, thyroid or parathyroid levels, cardiovascular disease, depression at screening will be excluded, if considered clinically significant by the Principal Investigator.

• Subject who is currently participating in another investigational study or has been taking any investigational drug within the last 4 weeks before screening for this study.

• Any other criteria, which, in the opinion of the investigator, suggests that the subject would not be compliant with the study protocol and/or would not be suitable to participate in this study.