Spinal Cord Injury Clinical Trial
Official title:
The Safety of Autologous Human Schwann Cells (ahSC) in Subjects With Subacute Spinal Cord Injury (SCI)
NCT number | NCT01739023 |
Other study ID # | 20081061 |
Secondary ID | |
Status | Completed |
Phase | Phase 1 |
First received | |
Last updated | |
Start date | November 2012 |
Est. completion date | August 2016 |
Verified date | March 2019 |
Source | University of Miami |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The purpose of this study is to assess the safety of autologous human Schwann cells (ahSC)
transplantation in subjects with subacute SCI.
For humans with subacute SCI, we hypothesize that axons might show improved function if
myelin repair is induced with the implantation of ahSC. In addition spinal cord cavitation
may be reduced, and neural sprouting and plasticity may be enhanced via neurotrophic effects.
Status | Completed |
Enrollment | 9 |
Est. completion date | August 2016 |
Est. primary completion date | August 2016 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 60 Years |
Eligibility |
Inclusion Criteria: - 1) Persons with traumatic SCI that occurred within the previous 30 days. - 2) Between the ages of 18 and 60 at last birthday. - 3) SCI at a thoracic level between T3-T11 as defined by MRI and the most caudal level of intact motor and sensory function on the International Standards for Neurological Classification of Spinal Cord Injury (ISNCSCI). - 4) Acute SCI with ISNCSCI grade A impairment at time of enrollment. Exclusion Criteria: - 1) Persons with penetrating injury of the spinal cord or complete transection of the cord, including bone fragment lacerations, as identified by magnetic resonance imaging (MRI). - 2) Persons with a lesion in the conus medullaris, cauda equina, or lower extremity peripheral nerve. - 3) Persons unable to safely undergo an MRI. - 4) Persons in whom adequate MRI imaging cannot be obtained. - 5) Persons who have developed a pulmonary embolism (PE) or deep vein thrombosis (DVT). - 6) Other traumatic injuries (e.g., CHI, another level of SCI) affecting the ability to provide informed consent and participate fully in rehabilitation. - 7) Persons with self-reported persistent severe neuropathic pain, inadequately controlled by non-narcotic medication. - 8) Persons with severe persistent mechanical or thermal hypersensitivity/allodynia at the neurological level or rostral to it as documented by clinical testing. - 9) Pregnant women or a positive pregnancy test in those women with reproductive potential prior to enrollment. - 10) Presence of systemic disease that might interfere with subject safety, compliance, or evaluation of the condition under study. - 11) Presence of any unstable medical or psychiatric condition that could reasonably be expected to subject the participant to unwarranted risk from participation in the study or result in a significant deterioration of his/her clinical course. - 12) Body Mass Index (BMI) > 35. - 13) History of active substance abuse. - 14) Persons who have participated in other experimental treatments within the past 90 days deemed by the PI to represent a possible confound or enrolled in any other ongoing trial. - 15) Persons with significant lower extremity injury, previous surgery, or amputation such that would preclude satisfactory sural nerve harvest. - 16) Persons allergic to gentamicin - 17) Persons who test positive for HIV or Hepatitis B or C virus. - 18) Baseline entry criteria for renal function, CBC, INR, and liver tests including serum albumin, total bilirubin, alanine transaminase (ALT), aspartate transaminase (AST), alkaline phosphastase (ALP), and gamma glutamyl transpeptidase (GGT). Persons with lab values that are concerning in the context of SCI may be excluded from participating in the trial if these indicate chronic or severe acute pathology. - 19) Persons with autoimmune diseases, for which chronic corticosteroids or immunosuppression therapy may be needed. - 20) Persons with clinically documented malignancy in the past 5 years except for treated non-melanoma skin cancers. |
Country | Name | City | State |
---|---|---|---|
United States | University of Miami Miller School of Medicine | Miami | Florida |
Lead Sponsor | Collaborator |
---|---|
W. Dalton Dietrich | The Miami Project to Cure Paralysis |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | International Standards of Neurological Classification for Spinal Cord Injury | Change from Baseline at 12 months | ||
Primary | MRI of spinal cord | Change from Baseline at 12 months | ||
Primary | Neuropathic pain | Change from Baseline at 12 months | ||
Secondary | Spinal Cord Independence Measure III | Change from Baseline at 12 months | ||
Secondary | Functional Independence Measure | Change from Baseline at 12 months | ||
Secondary | Motor Evoked Potentials | Change from Baseline at 12 months | ||
Secondary | Somatosensory Evoked Potentials | Change from Baseline at 12 months | ||
Secondary | Autonomic - Head-up Tilt | Change from Baseline at 12 months | ||
Secondary | Autonomic - Sympathetic Skin Response | Change from Baseline at 12 months | ||
Secondary | ISCI Basic Bowel Dataset | Change from Baseline at 12 months | ||
Secondary | ISCI Basic Lower Urinary Tract Dataset | Change from Baseline at 12 months | ||
Secondary | SF-12 | Change from Baseline at 12 months | ||
Secondary | Patient Global Impression of Change | Change from Baseline at 12 months | ||
Secondary | Modified Ashworth Scale | Change from Baseline at 12 months |
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