Safety of Autologous Human Schwann Cells (ahSC) in Subjects With Subacute SCI

Completed · Phase 1

Conditions studied: Spinal Cord Injury, Paraplegia

In brief

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.

Key facts

Study ID

NCT01739023

Run by

W. Dalton Dietrich

People needed

9

Starts

2012-11-01

Expected to finish

2016-08-01

Last updated by the study team

2019-03-05

Who can join

Age: 18 and older, up to 60. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• University of Miami Miller School of Medicine — Miami, Florida, United States

Full record on ClinicalTrials.gov

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