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Spinal Cord InjuryPhase 1NCT01739023

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

A Phase 1 study testing Autologous Human Schwann Cells in people with Spinal Cord Injury and Paraplegia, run by W. Dalton Dietrich at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 to 60 years
Conditions the study is for
Spinal Cord Injury, Paraplegia
What is being tested?
Autologous Human Schwann Cells
Could I receive a placebo?
No, everyone receives an active treatment
How many people
9 participants
Where
1 siteUnited States
Study dates
Nov 2012to Aug 2016
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 60 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • 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.

Who cannot join

  • 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.
Show all 20Show fewer
  • 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.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • University of Miami Miller School of Medicine

    Miami, Florida, 33136

Other trials in United States

About this study

Official title: The Safety of Autologous Human Schwann Cells (ahSC) in Subjects With Subacute Spinal Cord Injury (SCI)

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.

Read the detailed description

Schwann cells are excellent candidates for transplantation into humans with SCI. Large numbers of ahSC can be derived for autologous implantation after a minor surgery for peripheral nerve harvesting, and purification and expansion of the cells in culture. Autologous cells offer important safety advantages that include no need for immune suppression, minimal risk of disease transfer, and a low risk of tumorigenicity.

Since 1990, scientists at the Miami Project to Cure Paralysis have generated extensive preclinical data suggesting Schwann cell transplantations are successful in rodents with SCI. The most recent work has focused on contusive injury models that are relevant to human injury. They have also been largely responsible for developing an efficient method for procuring large, essentially pure populations of human Schwann cells from adult peripheral nerve.

The rationale for implantation of ahSC in people with acute SCI is based on the evidence that Schwann cells are neuroprotective and are capable of myelinating axons. Using mitogen expanded human Schwann cells in SCID mice and athymic female nude rats demonstrated that human Schwann cells can survive and are capable of enhancing axonal regeneration and forming myelin after transplantation in animals with sciatic nerve transection or thoracic spinal cord transection. The proposed clinical trial will advance knowledge about the safety and feasibility of a cell-based treatment strategy for human SCI.

This Phase 1 clinical trial will employ an open label, unblinded, nonrandomized and non-placebo controlled dose-escalation design to evaluate the safety of transplantation of ahSC transplantation in subjects with subacute SCI.

A sural nerve harvest will occur within 30 days post-injury. Standard-of-care medical treatment and rehabilitation will proceed while the cells are being processed in a cGMP facility. No later than 72 days post-injury, the ahSC product will be administered via a single injection into the cavity of the spinal cord lesion.

Safety and efficacy assessments will be performed at week 1 and 2 post-transplantation and 2, 6, and 12 months post-transplantation.

Being tested
Autologous Human Schwann Cells
Keywords
paraplegia, cell therapy, Schwann cells, spinal cord injury
Medical subject headings
Spinal Cord Injuries, Paraplegia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Autologous Human Schwann CellsBiological

    Schwann cells harvested from the sural nerve of the participant will be autologously transplanted into the epicenter of the participant's spinal cord injury.

Study groups in NCT01739023
Study groupRoleWhat they receive
Autologous Human Schwann CellsExperimentalNot described
Receives: Biological: Autologous Human Schwann Cells

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. International Standards of Neurological Classification for Spinal Cord Injury

    Measured: Change from Baseline at 12 months

  2. MRI of spinal cord

    Measured: Change from Baseline at 12 months

  3. Neuropathic pain

    Measured: Change from Baseline at 12 months

Secondary outcomes (11)

  1. Spinal Cord Independence Measure III

    Measured: Change from Baseline at 12 months

  2. Functional Independence Measure

    Measured: Change from Baseline at 12 months

  3. Motor Evoked Potentials

    Measured: Change from Baseline at 12 months

  4. Somatosensory Evoked Potentials

    Measured: Change from Baseline at 12 months

  5. Autonomic - Head-up Tilt

    Measured: Change from Baseline at 12 months

  6. Autonomic - Sympathetic Skin Response

    Measured: Change from Baseline at 12 months

  7. ISCI Basic Bowel Dataset

    Measured: Change from Baseline at 12 months

  8. ISCI Basic Lower Urinary Tract Dataset

    Measured: Change from Baseline at 12 months

  9. SF-12

    Measured: Change from Baseline at 12 months

  10. Patient Global Impression of Change

    Measured: Change from Baseline at 12 months

  11. Modified Ashworth Scale

    Measured: Change from Baseline at 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 Nov 2012 (estimated)
  2. Study startNov 2012
  3. Primary completionAug 2016
  4. Study completionAug 2016

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
9 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01739023
Sponsor's protocol ID
20081061
Status last verified
Mar 2019
First submitted
28 Nov 2012
Last updated
5 Mar 2019
Results posted
No
Data monitoring committee
Yes
Individual data sharing
Undecided
Expanded access
Available

Publications

  • Anderson KD, Guest JD, Dietrich WD, Bartlett Bunge M, Curiel R, Dididze M, Green BA, Khan A, Pearse DD, Saraf-Lavi E, Widerstrom-Noga E, Wood P, Levi AD. Safety of Autologous Human Schwann Cell Transplantation in Subacute Thoracic Spinal Cord Injury. J Neurotrauma. 2017 Nov 1;34(21):2950-2963. doi: 10.1089/neu.2016.4895. Epub 2017 Mar 21.

    PubMed 28225648

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Autologous Human Schwann Cells in people with Spinal Cord Injury and Paraplegia, run by W. Dalton Dietrich at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 5 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

International Standards of Neurological Classification for Spinal Cord Injury (time frame: Change from Baseline at 12 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01739023, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Mar 2019.

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