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Spinal Cord InjuryPhase 1NCT02354625

The Safety of ahSC in Chronic SCI With Rehabilitation

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 cell (ahSC) transplantation in participants with chronic SCI. This trial design is phase I, open label, unblinded, non-randomized, and non-placebo controlled multiple injury cohorts. Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Spinal Cord Injury, Paraplegia, Quadriplegia
What is being tested?
Autologous human Schwann cells
Could I receive a placebo?
No, everyone receives an active treatment
How many people
8 participants
Where
1 siteUnited States
Study dates
Jan 2015to 12 Aug 2019
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 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Persons with traumatic SCI that occurred a minimum of 12 months prior to enrollment;
  • Between the ages of 18 and 65 at last birthday;
  • SCI between spinal levels C5-T12 as defined by the most caudal level of intact motor and sensory function on the International Standards for Neurological Classification of Spinal Cord Injury (ISNCSCI);
  • ASIA Impairment Scale (AIS) grade A, B, or C at time of enrollment;
  • Lesion length less than or equal to 3 cm and lesion volume less than or equal to 2 cc, as approximated by MRI.

Who cannot join

  • Persons unable to safely undergo an MRI;
  • Persons with penetrating injury of the spinal cord or complete transection of the cord, as identified by MRI;
  • Persons with severe, uncorrected post-injury spinal deformity and/or spinal cord inadequately decompressed;
  • Persons with a cavity structure that would preclude successful transplantation, as identified by MRI;
  • Persons with syringomyelia - defined as patients with progressively enlarging cysts on T2 weighted images with associated neurological decline;
  • Persons with pre-existing conditions that would preclude satisfactory sural nerve harvest;
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  • Intolerance to functional electrical stimulation of muscles;
  • Exercise induced abnormalities;
  • Range of motion of the upper or lower extremities outside functional limits for targeted fitness and rehabilitation activities;
  • Evidence of bone or joint pathology that adversely influences participation in the fitness and rehabilitation activities;
  • Fracture, dislocation, or extremity instruments (implanted or external) that adversely influences participation in the fitness and rehabilitation activities;
  • Unhealed pressure ulcer;
  • History of documented seizures, stroke, brain tumor, serious head injury, or any other intracranial problem that could increase the risk of seizures during motor evoked potentials testing;
  • Pregnant women or a positive pregnancy test in those women with reproductive potential prior to enrollment;
  • Presence of disease that might interfere with participant safety, compliance, or evaluation of the condition under study;
  • Body Mass Index (BMI) ≥ 35;
  • History of active substance abuse;
  • Persons who are current participants in any interventional trial;
  • Persons with a history of prior intrathecal or intraspinal cell therapy for SCI;
  • Persons allergic to gentamicin;
  • Persons who test positive for HIV or Hepatitis B or C virus;
  • Persons with lab values significantly outside of the upper and lower limits;
  • Persons who can independently ambulate.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • University of Miami

    Miami, Florida, 33136

Other trials in United States

About this study

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

The purpose of this study is to assess the safety of autologous human Schwann cell (ahSC) transplantation in participants with chronic SCI.

This trial design is phase I, open label, unblinded, non-randomized, and non-placebo controlled multiple injury cohorts.

Read the detailed description

For humans with chronic 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. In this trial, subjects will receive fitness conditioning and rehabilitation prior to transplantation in order to validate the stability of their neurological baseline and enhance their ability to undergo surgery with few complications. They will also receive fitness conditioning and rehabilitation post-transplantation to maintain health and promote neuronal activity and potential neuroplasticity.

Trial enrollment will target 2 cohorts. The first cohort will be thoracic (T) level 2-12 ASIA Impairment Scale (AIS) grade A, B, or C (n = up to 4), the second cohort will be cervical (C) level 5 through T1 AIS A, B, or C (n = up to 6). Two (2) participants with AIS grade A will be enrolled prior to enrolling a participant with AIS B or C, applicable to both cohorts.

Participants will be monitored throughout a 6 month post-transplantation evaluation period for occurrence of AEs (acute, delayed, and/or cumulative), as well as for changes in clinical status and neurological status. Safety and efficacy assessments will be performed at weeks 1 and 2 post-transplantation and months 2 and 6 post-transplantation.

Being tested
Autologous human Schwann cells
Keywords
Schwann cells
Medical subject headings
Spinal Cord Injuries, Paraplegia, Quadriplegia

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 NCT02354625
Study groupRoleWhat they receive
ahSC transplantationExperimentalAutologous human Schwann cells
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 of Spinal Cord Injury

    Measured: Change from Baseline at 6 months

  2. Magnetic Resonance Imaging of spinal cord

    Measured: Change from Baseline at 6 months

  3. Neuropathic Pain Symptoms Inventory

    Measured: Change from Baseline at 6 months

  4. ISCI Basic Pain dataset version2

    Measured: Change from Baseline at 6 months

  5. Pain Diagram

    Measured: Change from Baseline at 6 months

  6. Quantitative Sensory Testing

    Measured: Change from Baseline at 6 months

Secondary outcomes (22)

  1. Spinal Cord Independence Measure III

    Measured: Change from Baseline at 6 months

  2. SCI-Functional Index Computer Adaptive Testing

    Measured: Change from Baseline at 6 months

  3. 10-Meter Walk Test

    Measured: Change from Baseline at 6 months

  4. 2-Minute Walk Test

    Measured: Change from Baseline at 6 months

  5. Timed Up and Go

    Measured: Change from Baseline at 6 months

  6. Timed Stair Climb

    Measured: Change from Baseline at 6 months

  7. Capabilities of Upper Extremity Questionnaire

    Measured: Change from Baseline at 6 months

  8. ISCI Upper Extremity Basic dataset

    Measured: Change from Baseline at 6 months

  9. ISCI Basic Bowel dataset

    Measured: Change from Baseline at 6 months

  10. ISCI Basic Lower Urinary Tract dataset

    Measured: Change from Baseline at 6 months

  11. ISCI Basic Male and Female Sexual Function datasets

    Measured: Change from Baseline at 6 months

  12. ISCI Quality of Life dataset

    Measured: Change from Baseline at 6 months

  13. Motor Evoked Potentials

    Measured: Change from Baseline at 6 months

  14. Somatosensory Evoked Potentials

    Measured: Change from Baseline at 6 months

  15. Sympathetic Skin Response

    Measured: Change from Baseline at 6 months

  16. Graded Strength Test

    Measured: Change from Baseline at 6 months

  17. 1-Repetition Maximum

    Measured: Change from Baseline at 6 months

  18. Head-up Tilt

    Measured: Change from Baseline at 6 months

  19. Guy Farrar Subject Global Impression of Change

    Measured: Change from Baseline at 6 months

  20. Modified Ashworth Scale

    Measured: Change from Baseline at 6 months

  21. Pendulum Test

    Measured: Change from Baseline at 6 months

  22. Spinal Cord Assessment Tool for Spastic reflexes

    Measured: Change from Baseline at 6 months

Timeline

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

  1. First posted3 Feb 2015 (estimated)
  2. Study startJan 2015
  3. Primary completion12 Aug 2019
  4. Study completion12 Aug 2019

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
8 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02354625
Sponsor's protocol ID
20140846
Status last verified
Aug 2019
First submitted
29 Jan 2015
Last updated
14 Aug 2019
Results posted
No
Data monitoring committee
Yes

Publications

  • Maher JL, Anderson KD, Gant KL, Cowan RE. Development and deployment of an at-home strength and conditioning program to support a phase I trial in persons with chronic spinal cord injury. Spinal Cord. 2021 Jan;59(1):44-54. doi: 10.1038/s41393-020-0486-7. Epub 2020 Jun 3.

    PubMed 32493977

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 5 inclusion and 23 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 14 Aug 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 of Spinal Cord Injury (time frame: Change from Baseline at 6 months). The study lists 6 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 NCT02354625, 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 14 Aug 2019.

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