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Spinal Cord InjuriesPhase 2/3SCI2NCT03935724

Stem Cells in Spinal Cord Injury

A Phase 2/3 study testing Neuro-Cells in people with Spinal Cord Injuries and Acute Spinal Cord Injury, run by Neuroplast at 2 sites in 2 countries.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

This is a multicenter, randomized, double-blind, placebo-controlled and delayed-start phase II/III clinical study. Read more about this study

Who is it for?
Ages 18 to 65 years
What is being tested?
Neuro-Cells
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
16 participants
Where
2 sitesin 2 countries
Study dates
18 Jan 2022to 1 Aug 2024
Phase
Phase 2/3
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

  • Age range: 18 - 65 years
  • Complete (AIS grade A) or incomplete (AIS grade B or C) TSCI (ISNCSCI-assessed) at time of randomization
  • Randomization can be done within 6-10 weeks after the TSCI incident
  • Level of injury between C4 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
  • Level of SCI above C4 or below T12
  • Positive HIV, hepatitis B or C serology
  • Positive Lues test
  • Total Nuclear Cell (TNC) count < 1x109 TNC
  • 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
Show all 14Show fewer
  • Patients suffering from respiratory issues that cannot breathe on their own 24/7
  • 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, 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

2 sites in 2 countries.

2 sites in 2 countries

Denmark1 site

  • Rigshospitalet

    Copenhagen, 2100

Other trials in Denmark

Spain1 site

  • Hospital Nacional de Parapléjicos

    Toledo, 45004

Other trials in Spain

About this study

Official title: A Multi-center, Double-blind, Randomized, Placebo-controlled, Delayed Start Phase II/III Study to Assess the Efficacy and Safety of Neuro-Cells in (Sub)Acute Spinal Cord Injury Patients

This is a multicenter, randomized, double-blind, placebo-controlled and delayed-start phase II/III clinical study.

Read the detailed description

Phase II of the study focuses on establishing the safety and efficacy of the fist-in-human administration of Neuro-Cells. In phase III efficacy and safety will be further investigated. Enrollment in phase III of the study will automatically start once all patients have been enrolled and treated in phase II. The recruitment period is estimated at respectively 6 months for both the Phase II and Phase III.

Phase II starts with the enrollment of 16 evaluable patients, randomly divided in two groups of 8 evaluable patients each. After an interim intervention analysis, the phase II study expands into a phase III study, requiring the recruitment of 54 additional evaluable patients. Patients recruited for the phase III part will be randomly divided in two groups of 27 evaluable patients each. Details on the planned analyses can be found in section 8 'Statistical Analysis'.

Both the phase II and phase III part of the trial have a similar setup which includes a screening period (1 - 2 days), a randomization, a treatment period of 1 or 2 days and a total follow-up period of 1 year.

All patients undergo a BM harvesting at the start of their participation in the study and will undergo three LPs, performed to administer Neuro-Cells or placebo and/or to collect CSF for research purposes. Neuro-Cells and placebo are both administered as a single dose by an 'unblinded physician'. This physician is different from the 'blinded Investigators and study nurses' responsible for patient selection and follow-up. This study set-up allows to maintain a double-blind status of the patients and the Investigators responsible for the patients' evaluation throughout the first six months of both studies. This is because, approximately six months after the time of inclusion, the patients assigned to the placebo group will undergo a second BM harvesting and will also receive Neuro-Cells. All patients are followed up until approximately one year after the time of inclusion. All patients will have been treated with Neuro-Cells and will have completed follow-up for at least 6 months post-treatment. Patient recruitment, randomization and blinding, and the primary and secondary objectives are identical in the phase II and the phase III part of the study. The study is completed when the last patient finishes his/her last visit, approximately one year after the time of inclusion.

Being tested
Neuro-Cells
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.

  • 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 NCT03935724
Study groupRoleWhat they receive
1A Intervention group 8 patientsExperimentalNeuro-Cells treatment at day 1-2 (= 6-10 weeks after TSCI incident). N=8
Receives: Biological: Neuro-Cells
1B Placebo group 8 patientsPlacebo comparatorPlacebo treatment at day 1-2 (= 6-10 weeks after TSCI incident) Neuro-Cells treatment at day 181-182 (= 32-34 weeks after TSCI incident) N=8
Receives: Biological: Neuro-Cells
2A Intervention group 27 patientsExperimentalNeuro-Cells treatment at day 1-2 (= 6-10 weeks after TSCI incident) N=27
Receives: Biological: Neuro-Cells
2B Placebo group 27 patientsPlacebo comparatorPlacebo treatment at day 1-2 (= 6-10 weeks after TSCI incident) Neuro-Cells treatment at day 181-182 (= 32-34 weeks after TSCI incident) N=27
Receives: Biological: Neuro-Cells

What is being measured

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

  1. Physical changes after intrathecal intervention with Neuro-Cells

    At approx. 3 months after intrathecal intervention with Neuro-Cells (day 90 for the patients treated 6-10 weeks after the TSCI incident and day 270 for the patients treated at 32-34 weeks after the TSCI incident) a physical examination (checklist) will be done

    Measured: 9 months

  2. Increase of motor scores after intrathecal invervention with Neuro-Cells

    Increase in the ISNCSCI motor scores with additional 5 points from baseline (visit 2) at 6 months after the intrathecal intervention (day 180) in patients treated with Neuro-Cells

    Measured: 6 months

Secondary outcomes (2)

  1. Increase of motor scores after late administration of Neuro-Cells

    Increase in the ISNCSCI motor scores with additional 5 points from baseline (visit 5) at 6 months after the intrathecal intervention (day 360) in patients treated with Neuro-Cells 32 to 34 weeks after the TSCI incident as compared to placebo treated patients

    Measured: 12 months

  2. Change in autonomic and sensoric neurological dysfunctionafter intrathecal invervention with Neuro-Cells

    The American Spinal Injury Association (ASIA) Impairment Scale involves both a Motor and Sensory examination for each side of the body (left/right).

    The Sensory examination involves 'light touch' and 'pinprick' for each dermatome (28) on both sides of the body (total 56). A score of 0, 1 or 2 can be given to each dermatome resulting in a total max. of 112 points.

    The Motor level is determined by examining the muscle function within each of the 10 myotomes on each side of the body (20 myotomes in total). A score ranging from 1 to 5 can be given resulting in a maximum score of 100.

    The higher the value, the better the outcome.

    Measured: 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 posted2 May 2019
  2. Study start18 Jan 2022
  3. Primary completion1 Feb 2024 (estimated)
  4. Study completion1 Aug 2024 (estimated)

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 2/3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Patients are randomized into two groups. First groups receives Neuro-cells, second group receives placebo. After six months second group also receives Neuro-cells. This happens in phase 2 and is repeated in phase 3. Therefore there are 4 groups.
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
16 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03935724
Sponsor's protocol ID
A2017SCI03
Acronym
SCI2
Status last verified
Sep 2023
First submitted
23 Apr 2019
Last updated
29 Sep 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 2/3 study testing Neuro-Cells in people with Spinal Cord Injuries and Acute Spinal Cord Injury, run by Neuroplast at 2 sites in 2 countries.

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 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: status not confirmed, as of the sponsor's last update on 29 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Denmark, 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

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

Are results available for this study?

Results are not available in the source record.

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?

Physical changes after intrathecal intervention with Neuro-Cells (time frame: 9 months). The study lists 2 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 NCT03935724.

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 29 Sep 2023.

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