Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 2:10 AM
Ignite Modification Date:
2025-12-25 @ 2:10 AM
NCT ID:
NCT01328860
Eligibility Criteria:
Inclusion Criteria:
1. Between 1 year and 15 years of age on the day of study BMPC infusion.
2. Survived at least six months with PSCI, but are less than 4 years post injury (± 30 days), and have fixed neurologic deficits related to their injury at the time of enrollment.
3. Ability of child to understand and speak English.
4. Ability of child and caregiver to travel to Houston, Texas, and stay for at least 4 days, and to return for all Follow-up visits (patient is responsible for cost of travel and lodging while in Houston).
5. Pediatric patients with any type of spinal cord injury as long as their spinal cords are continuous on MRI evaluation. This includes paraplegic and quadriplegic patients with complete or incomplete spinal cord injuries. This includes patients with ASIA impairment scales from A to D. The clinical classification will be described by the level below which motor/sensory function is impaired, and the degree of that impairment. (i.e. C-5 if the deltoid muscle is intact but the biceps and other muscle groups below the C-5 level are weak \[incomplete motor injury\] or paralyzed \[complete motor injury\]. A similar evaluation of sensory function will be established clinically.
Exclusion Criteria:
1. Lack of informed consent.
2. Uncorrected coagulopathy during the baseline period defined as: INR \> 1.4; PTT \> 35 sec; PLT \< 100,000.
3. Pre-injury history of seizure disorder and/or neurological impairment where the patient would not be able to participate in age appropriate pain rating scales.
4. A history of prior SCI or severe traumatic brain injury.
5. Known history of:
* Recently diagnosed infection (within past 2 weeks) requiring treatment and/or medical intervention.
* Renal disease or altered renal function as defined by serum creatinine \> 1.5 mg/dL.
* Hepatic disease or altered liver function as defined by SGPT \> 150 U/L, and/or T. Bilirubin \> 1.3 mg/dL.
* Malignancy.
* Immunosuppression as defined by WBC \< 3 (10x3) at screening and/or baseline evaluation lab.
* HIV.
* Hepatitis B or C.
8\. Unhealed fractures or wounds including osteomyelitis.
9\. Pneumonia, or chronic lung disease requiring oxygen.
10\. An anatomically discontinuous spinal cord diagnosed by CT or MRI imaging.
11\. Positive urine pregnancy test (urine pregnancy test will be routinely performed on females of childbearing potential, age 11 or older.
12\. Participation in a concurrent intervention study.
13\. Desire for organ-donation in the event of death.
14\. Unwillingness or inability to stay for at least four days following BMPC infusion (should any problems arise following the infusion) and to return for a 30 day, and 6 month follow-up visit, and be available for 1 year, and 2 year follow-up phone calls.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
1 Year
Maximum Age:
15 Years
Study:
NCT01328860
Study Brief:
Protocol Section:
NCT01328860