Autologous Stem Cells for Spinal Cord Injury (SCI) in Children
Stopped early · Phase 1
Conditions studied: Spinal Cord Injury
In brief
The purpose of this research study is: 1. To see if Bone Marrow Cell harvest and transplantation are safe in children with Spinal Cord Injury, and 2. To determine if late functional outcome is improved following Bone Marrow Cell transplantation in children with Spinal Cord Injury, using pre-transplantation spinal cord function as the control.
Key facts
- Study ID
- NCT01328860
- Run by
- Aryn Knight
- People needed
- 10
- Starts
- 2011-04-01
- Expected to finish
- 2016-06-01
- Last updated by the study team
- 2024-03-20
Who can join
Age: 1 and older, up to 15. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Between 1 year and 15 years of age on the day of study BMPC infusion.
- 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.
- Ability of child to understand and speak English.
- 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).
- 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.
You may not qualify if…
- Lack of informed consent.
- Uncorrected coagulopathy during the baseline period defined as: INR > 1.4; PTT > 35 sec; PLT < 100,000.
- 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.
- A history of prior SCI or severe traumatic brain injury.
- 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.
- Unhealed fractures or wounds including osteomyelitis.
- Pneumonia, or chronic lung disease requiring oxygen.
- An anatomically discontinuous spinal cord diagnosed by CT or MRI imaging.
- Positive urine pregnancy test (urine pregnancy test will be routinely performed on females of childbearing potential, age 11 or older.
- Participation in a concurrent intervention study.
- Desire for organ-donation in the event of death.
- 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.
Where it is running
- Children's Memorial Hemann Hospital; University of Texas Health Science Center - Houston — Houston, Texas, United States
Full record on ClinicalTrials.gov
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