Autologous Stem Cells for Spinal Cord Injury (SCI) in Children

NCT01328860 | Terminated Phase 1 DMC

• 1 other identifier: BBIND14281
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this research study is:

1. 1.To see if Bone Marrow Cell harvest and transplantation are safe in children with Spinal Cord Injury, and
2. 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.

Conditions

Spinal Cord Injury

Keywords

Autologous; Stem Cells; Spinal Cord Injury; Children

Outcome Measures

Primary Outcomes (1)

• American Spinal Injury Association (ASIA) - Standard Neurological Classification of Spinal Cord Injury.

  ASIA classification assessment will take place pre-procedure, 1 day, 30 days, and 180 days post-procedure to define changes in functional outcome.

  180 days

Secondary Outcomes (1)

• Standard Neuropathic Pain Rating Scale

  2 years

Study Arms (1)

Biologic; Stem Cells

EXPERIMENTAL

Biological: bone marrow progenitor cells (BMPC) autologous transplantation

Interventions

bone marrow progenitor cells (BMPC) autologous transplantation BIOLOGICAL

Not more than 5ml/kg bone marrow will be collected under anesthesia; after the bone marrow has been processed, about 6-8 hours after bone marrow aspiration, subjects will receive the cells via intra-venous (in the vein) infusion and will be monitored for 24 hours for any adverse events.

Also known as: Autologous Stem Cells, Patient's own Stem Cells

Biologic; Stem Cells

Eligibility Criteria

• Age: 1 Year - 15 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

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.

Sponsors & Collaborators

• Aryn Knight: lead
• The Institute for Rehabilitaion and Research Foundation: collaborator
• The University of Texas Health Science Center, Houston: collaborator
• M.D. Anderson Cancer Center: collaborator
• Baylor College of Medicine: collaborator
• Florida Hospital for Children: collaborator

Study Sites (1)

Children's Memorial Hemann Hospital; University of Texas Health Science Center - Houston

Houston, Texas, 77030, United States

Location

MeSH Terms

Conditions

Spinal Cord Injuries

Interventions

Transplantation, Autologous

Condition Hierarchy (Ancestors)

Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Transplantation; Surgical Procedures, Operative

Study Officials

• James E. Baumgartner, MD

  MHHS, Houston,TX & FL Hospital for Children, Orlando, FL

  STUDY CHAIR

• Rex A. Marco, MD

  University of Texas Health Science Center, Houston TX

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: AVP Research

Study Record Dates

• First Submitted: April 1, 2011
• First Posted: April 5, 2011
• Study Start: April 1, 2011
• Primary Completion: June 1, 2014
• Study Completion: June 1, 2016
• Last Updated: March 20, 2024

Record last verified: 2024-03

Locations

US (1)