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Spinal Cord InjuriesPhase 1SSCiSCINCT04205019

Safety Stem Cells in Spinal Cord Injury

A Phase 1 study testing Neuro-Cells in people with Spinal Cord Injuries, run by Neuroplast at 1 site in Spain.

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

Mono-center, open label study to investigate the safety of Neuro-Cells in 10 end stage (chronic) traumatic spinal cord injury (TSCI) patients, when administered once intrathecally. Read more about this study

Who is it for?
Ages 18 to 40 years
Conditions the study is for
Spinal Cord Injuries
What is being tested?
Neuro-Cells
Could I receive a placebo?
No, everyone receives an active treatment
How many people
10 participants
Where
1 siteSpain
Study dates
14 Nov 2020to 10 Mar 2023
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 40 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • Age range: 18 - 40 years
  • Complete (AIS grade A) or incomplete (AIS grade B) TSCI (ISNCSCI-assessed) at time of recruitment
  • Level of injury between C5 to T12
  • Voluntary signed informed consent by patients and Investigator before any trial-related procedures are performed

Who cannot join

  • SCI AIS grade D or E at the start of enrolment
  • Allergic to mice antibodies and/or iron-dextran
  • Level of SCI above C5 or below T12
  • Positive HIV, hepatitis B or C serology
  • Positive Lues test
  • Total Nuclear Cell (TNC) count < 1x109 TNC
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  • Cancer, brain injury, disturbed consciousness, signs/symptoms of neurodegenerative disorder (e.g. stroke, amyotrophic lateral sclerosis, multiple sclerosis etc), diabetes mellitus type 1, renal or cardiac insufficiency based on anamnesis history and at the investigator's discretion
  • Any concomitant treatment or medication that interferes with the conduct of the trial, such as immune-suppressive medication or other medication (especially methotrexate, cyclosporine, and corticosteroids have to be avoided) known to interact with the anti-inflammatory and immune-modulative actions of stem cells (non-steroid anti-inflammatory drugs (NSAIDs) are allowed)
  • Abuse of alcohol (daily consumption of more than 2 units of alcohol containing drinks) or illicit drugs (e.g. heroin, cocaine, XTC)
  • Individuals that belong to vulnerable population groups
  • Females with childbearing potential without using adequate birth control methods (e.g. contraceptive pills, intrauterine devices (IUD), contraceptive injections (prolonged-release), subdermal implantation, vaginal ring or transdermal patches), and/or being pregnant or in the lactation period
  • Participation in any clinical trial (with exemption of descriptive studies with questionnaires and no active intervention) within the previous 30 days before enrolment, or simultaneous participation in such trial
  • Patients with extreme comorbidity before or after the TSCI are excluded at discretion of the PI
  • Patients who are unable to comply with the requirements of this clinical trial

Trial locations and contacts

1 site in 1 country.

Spain1 site

  • Hospital Nacional de Parapléjicos

    Toledo, Castille-La Mancha, 45004

Other trials in Spain

About this study

Official title: A 3 Months Open Phase I Study to Assess the Safety of the Intrathecal Application of Neuro-Cells in End Stage (Chronic) Traumatic Spinal Cord Injury Patients

Mono-center, open label study to investigate the safety of Neuro-Cells in 10 end stage (chronic) traumatic spinal cord injury (TSCI) patients, when administered once intrathecally. TSCI is a rare disease without cure perspectives and Neuro-Cells is an autologous fresh stem cells containing product (one batch / one patient).

Read the detailed description

This phase I clinical study is an open clinical trial to investigate the safety of the intrathecal application of Neuro-Cells in the treatment of end stage (chronic), traumatic complete (AIS grade A) and incomplete (AIS grade B/C) SCI patients. To that purpose, after inclusion in this study >1 year and less than 5 years after their SCI-event, 10 patients will be included. All patients are invited to visit the trial hospital every month during this 3-months study for appreciation of their possible (S)AEs and/or SUSARs, for physical examination and a biochemical analysis of their blood/urine. Day 0 and day 90 they also undergo a comprehensive neurological examination, the AISIAms, ASIAss and Pain perception.

Finally, the participants are also invited to undergo neurological examinations at day 360 and 720. The purpose of this neurological assessment is to explore in patients if a late administration of Neuro-Cells may have some beneficial effects on the neurological condition of the chronic SCI patient.

All patients undergo a BM harvesting at the start of their participation in the study and will undergo one LP, performed to administer Neuro-Cells. The study is open and descriptive, and no randomization takes place. All patients are followed up until approximately 3 months after the time of administration. After these 3 months, the safety part of this study ends. Patients are invited for a neurological assessment 9 months later (day 360) to explore if Neuro-Cells may have a beneficial effect when given to end stage patients with a traumatic SCI.

The safety part of the study is completed when the last patient finishes his/her visit at day 90. The explorative part of the study ends approximately one year after the time of inclusion at day 720.

Being tested
Neuro-Cells
Keywords
Traumatic Spinal Cord Injury, Stem Cells
Medical subject headings
Spinal Cord Injuries

What participants receive

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

  • Neuro-CellsBiological

    Neuro-Cells is an autologous fresh stem cells containing product which modulates the secondary inflammation following a TSCI, reduces apoptosis (cell death) in the injured spinal cord, reduces scar tissue formation in the damaged spinal cord and creates a cell regenerative environment in the injured spinal cord.

Study groups in NCT04205019
Study groupRoleWhat they receive
Neuro-Cell groupExperimentalPatient receives treatment once at start of study and followed up for safety.
Receives: Biological: Neuro-Cells

What is being measured

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

  1. Characterize and confirm safety of intrathecal administration of Neuro-Cells by ISNCSCI checklist

    checklist in which the physician focusses on the spinal cord

    Measured: 3 months

  2. Characterize and confirm safety of intrathecal administration of Neuro-Cells assessed by blood

    Measuring biochemical blood variables

    Measured: 3 months

  3. Characterize and confirm safety of intrathecal administration of Neuro-Cells assessed by urine

    Measuring biochemical urine variables

    Measured: 3 months

  4. Characterize and confirm safety of intrathecal administration of Neuro-Cells by adverse events

    Severity of adverse events (if applicable)

    Measured: 3 months

Secondary outcomes (7)

  1. The effect of late administration of Neuro-Cells by change in American Spinal Injury Association motor scale score

    Change in the ASIAms score from baseline at 3 months, 12 months and 24 months. Higher score means more change.

    Measured: 24 months

  2. The effect of late administration of Neuro-Cells by change in American Spinal Injury Association sensory scale score

    Change in the ASIAss from baseline at 3 months, 12 months and 24 months. Higher score means more change.

    Measured: 24 months

  3. Investigate the effect of Neuro-Cells on the autonomic neurological dysfunction

    International Standards for Neurological Classification of Spinal Cord Injury assessment , a higher score means improvement

    Measured: 24 months

  4. The effect of Neuro-Cells on the sensory neurological dysfunction

    International Standards for Neurological Classification of Spinal Cord Injury assessment , a higher score means improvement

    Measured: 24 months

  5. The effect of Neuro-Cells on the daily activity level as measured by the Pain basic data set

    Pain basic data set using scale with the higher the mesaure the more pain, assessed by physician.

    Measured: 24 months

  6. The effect of Neuro-Cells on change in pain assessed by the pain basic data set scale.

    Pain basic data set using scale with the higher the mesaure the more pain, assessed by physician.

    Measured: 24 months

  7. The effect of Neuro-Cells on pain-reducing medication by looking at change in prescribed medication

    Documentation of concomitant medication and the change in prescriptions. Lower dose, less medication is bigger effect.

    Measured: 24 months

Timeline

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

  1. First posted19 Dec 2019
  2. Study start14 Nov 2020
  3. Primary completion18 Jun 2021
  4. Study completion10 Mar 2023

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
Model description
TSCI patients are treated once at start of the study and followed up for 3 months to characterize and confirm safety of intrathecal administration of Neuro-Cells.
Masking
None (open label)
Enrolment
10 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04205019
Sponsor's protocol ID
A2019SCI04
Acronym
SSCiSCI
Status last verified
Mar 2022
First submitted
21 Nov 2019
Last updated
28 Mar 2023
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Neuro-Cells in people with Spinal Cord Injuries, run by Neuroplast at 1 site in Spain.

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 14 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 28 Mar 2023. 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 Spain. 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?

Characterize and confirm safety of intrathecal administration of Neuro-Cells by ISNCSCI checklist (time frame: 3 months). The study lists 4 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 NCT04205019.

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 28 Mar 2023.

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