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Secondary Progressive Multiple Sclerosis (SPMS)Phase 1/2NCT03696485

Study to Assess the Safety and Efficacy of an IT Administration of SCM-010 in SPMS

A Phase 1/2 study testing SCM-010 in people with Secondary Progressive Multiple Sclerosis (SPMS), run by Stem Cell Medicine Ltd. at 1 site in Israel.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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Trial summary

Prospective, single center, open label, phase I/IIa escalating dose study. To evaluate the safety and efficacy of escalating doses of SCM-010 in subjects with SPMS. Read more about this study

Who is it for?
Ages 18 to 60 years
What is being tested?
SCM-010
Could I receive a placebo?
No, everyone receives an active treatment
How many people
0 participants
Where
1 siteIsrael
Study dates
1 Feb 2024to 1 Feb 2025
Phase
Phase 1/2
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

  • Male or female subjects (18-60 years of age) diagnosed with SPMS.
  • SPMS defined as relapsing-remitting disease followed by progression of disability independent of or not explained by multiple sclerosis (MS) relapses for at least 2 years.
  • Subjects should be ambulatory with an EDSS score of 3-6.5 (inclusive) at screening and baseline visits.
  • Subjects should be able to go through a lipoaspiration procedure, evaluated by the study's plastic surgeon.
  • Women capable of child bearing must have a negative urine pregnancy test at screening and baseline visits.
  • Subjects must use an adequate contraceptive method throughout the study.
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  • Coagulation tests including INR, PTT and prothrombin time (PT) within normal range.
  • Subjects must be willing and able to comply with the protocol requirements for the duration of the study.
  • Ability to provide written informed consent.

Who cannot join

  • Relapsing remitting multiple sclerosis (RRMS) or primary progressive multiple sclerosis (PPMS) as defined by the revised McDonald criteria.
  • Any chronic central nervous system (CNS) disease other than SPMS.
  • Clinical relapse within 3 months prior to study entry.
  • Subjects diagnosed with any systemic autoimmune disease.
  • Contraindications or inability to undergo lumbar puncture (LP) procedure and or intrathecal administration.
  • Severe anemia (hemoglobin < 10 g/dL).
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  • Abnormal renal function (serum creatinine more than 1.5xULN or creatinine clearance <30 ml/min).
  • Tested positive for HIV, hepatitis (HBV and HCV).
  • Known as positive for VDRL and/or tuberculosis.
  • Active malignant disease of any kind. However, a patient, who has had a malignant disease in the past, was treated and is currently disease - free for at least 7 years, may be considered eligible. In this case the sponsor medical expert approval is required.
  • Previous cell therapy treatment.
  • Previous total body irradiation or total lymphoid irradiation.
  • Previous use of natalizumab or any anti-B cell agent within 6 months prior to screening.
  • Previous use of immunosuppressant including Mitoxantrone, Alemtuzumab, Cladribine or any other cytotoxic agent.
  • Previous use of Fingolimod or Dimethyl Fumarate within 2 months prior to screening. Subjects who were treated with any of these medications will be excluded if they do not have a lymphocyte count within normal range at screening.
  • Previous use of Teriflunomide within 12 months if no accelerated elimination procedure was used.
  • Previous treatment with immunomodulators (including IFNβ 1a and 1b, and IV Immunoglobulin (IVIG) or Glatiramer Acetate (GA) within 2 months prior to screening.
  • A known history of hypersensitivity to one of following: Vancomycin, Cephalosporin, Cephamycin or beta-lactam antibacterial agent (penicillins, monobactams, carbapenems).
  • A known history of sensitivity to Gadolinium.
  • Inability to successfully undergo MRI scanning.
  • Treatment with any kind of steroids or ACTH during the last 30 days prior to screening.
  • Subjects with clotting disorders or receiving treatment with anticoagulants.
  • Any relevant medical, surgical, or psychiatric condition, laboratory value, or concomitant medication which, in the opinion of the Principle Investigator, makes the subject unsuitable for study entry or potentially unable to complete all aspects of the study.
  • Subjects with BMI < 20.
  • Pregnant or breast-feeding women.
  • Known or suspected drug or alcohol abuse.
  • Participation in any investigational drug study within 6 months prior to screening.

Trial locations and contacts

1 site in 1 country.

Israel1 site

  • Tel Aviv Medical Center

    Tel Aviv

Other trials in Israel

About this study

Official title: A Prospective, Single Center, Open Label, Dose Escalation Phase I/IIa Study to Assess the Safety and Efficacy of an Intrathecal Administration of SCM-010 in Subjects With Secondary Progressive Multiple Sclerosis (SPMS)

Prospective, single center, open label, phase I/IIa escalating dose study. To evaluate the safety and efficacy of escalating doses of SCM-010 in subjects with SPMS.

Read the detailed description

Twelve (12) SPMS subjects will be enrolled in this study in two dose cohorts. Each subject will receive SCM- 010 by intrathecal (IT) administration at baseline and will be followed up for 24 weeks for efficacy and 48 weeks for safety.

Being tested
SCM-010
Keywords
Secondary Progressive Multiple Sclerosis (SPMS), safety
Medical subject headings
Multiple Sclerosis, Chronic Progressive

What participants receive

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

  • SCM-010Biological

    SCM-010 is comprised of adipose derived expanded mesenchymal cells (ADSC), suspended in Plasma-Lyte and intended for intrathecal (IT) administration.

Study groups in NCT03696485
Study groupRoleWhat they receive
group 1: low doseExperimentalOne intrathecal (IT) administration of SCM-010 at baseline visit
Receives: Biological: SCM-010
group 2: high doseExperimentalOne intrathecal (IT) administration of SCM-010 at baseline visit
Receives: Biological: SCM-010

What is being measured

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

  1. Adverse Events (AEs) reported during the trial

    Safety data will be collected following the one IT administration of SCM-010 at baseline visit

    Measured: 48 weeks

Secondary outcomes (3)

  1. Change in MRI scans from baseline

    Changes in lesions from baseline MRI scan.

    Measured: 24 weeks

  2. Change from baseline in EDSS score

    The Expanded Disability Status Scale (EDSS) will be measured during the study. range of the scale 0-10

    Measured: 24 weeks

  3. Time to Confirmed Disease Progression (CDP)

    CDP for an individual subject is defined as at least 3-months confirmed EDSS increase from baseline.

    The Expanded Disability Status Scale (EDSS) will be measured during the study. range of the scale 0-10

    Measured: 24 weeks

Timeline

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

  1. First posted4 Oct 2018
  2. Study start1 Feb 2024 (estimated)
  3. Primary completion1 Feb 2025 (estimated)
  4. Study completion1 Feb 2025 (estimated)

Why it stopped: Due to sponsor decision

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 1/2
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Sequential
Masking
None (open label)
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03696485
Sponsor's protocol ID
SPMS-SCM-010
Status last verified
Apr 2024
First submitted
30 Sep 2018
Last updated
18 Apr 2024
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing SCM-010 in people with Secondary Progressive Multiple Sclerosis (SPMS), run by Stem Cell Medicine Ltd. at 1 site in Israel.

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 9 inclusion and 27 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: withdrawn, as of the sponsor's last update on 18 Apr 2024. 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 Israel. 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 combined 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.

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

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 was withdrawn before enrolling participants, so there are no results.

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?

Adverse Events (AEs) reported during the trial (time frame: 48 weeks). 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 NCT03696485.

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 18 Apr 2024.

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