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

April 16, 2024 updated by: Stem Cell Medicine Ltd.

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Withdrawn

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Israel
      • Tel Aviv, Israel
        • Tel Aviv Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Male or female subjects (18-60 years of age) diagnosed with SPMS.
  2. 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.
  3. Subjects should be ambulatory with an EDSS score of 3-6.5 (inclusive) at screening and baseline visits.
  4. Subjects should be able to go through a lipoaspiration procedure, evaluated by the study's plastic surgeon.
  5. Women capable of child bearing must have a negative urine pregnancy test at screening and baseline visits.
  6. Subjects must use an adequate contraceptive method throughout the study.
  7. Coagulation tests including INR, PTT and prothrombin time (PT) within normal range.
  8. Subjects must be willing and able to comply with the protocol requirements for the duration of the study.
  9. Ability to provide written informed consent.

Exclusion Criteria:

  1. Relapsing remitting multiple sclerosis (RRMS) or primary progressive multiple sclerosis (PPMS) as defined by the revised McDonald criteria.
  2. Any chronic central nervous system (CNS) disease other than SPMS.
  3. Clinical relapse within 3 months prior to study entry.
  4. Subjects diagnosed with any systemic autoimmune disease.
  5. Contraindications or inability to undergo lumbar puncture (LP) procedure and or intrathecal administration.
  6. Severe anemia (hemoglobin < 10 g/dL).
  7. Abnormal renal function (serum creatinine more than 1.5xULN or creatinine clearance <30 ml/min).
  8. Tested positive for HIV, hepatitis (HBV and HCV).
  9. Known as positive for VDRL and/or tuberculosis.
  10. 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.
  11. Previous cell therapy treatment.
  12. Previous total body irradiation or total lymphoid irradiation.
  13. Previous use of natalizumab or any anti-B cell agent within 6 months prior to screening.
  14. Previous use of immunosuppressant including Mitoxantrone, Alemtuzumab, Cladribine or any other cytotoxic agent.
  15. 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.
  16. Previous use of Teriflunomide within 12 months if no accelerated elimination procedure was used.
  17. Previous treatment with immunomodulators (including IFNβ 1a and 1b, and IV Immunoglobulin (IVIG) or Glatiramer Acetate (GA) within 2 months prior to screening.
  18. A known history of hypersensitivity to one of following: Vancomycin, Cephalosporin, Cephamycin or beta-lactam antibacterial agent (penicillins, monobactams, carbapenems).
  19. A known history of sensitivity to Gadolinium.
  20. Inability to successfully undergo MRI scanning.
  21. Treatment with any kind of steroids or ACTH during the last 30 days prior to screening.
  22. Subjects with clotting disorders or receiving treatment with anticoagulants.
  23. 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.
  24. Subjects with BMI < 20.
  25. Pregnant or breast-feeding women.
  26. Known or suspected drug or alcohol abuse.
  27. Participation in any investigational drug study within 6 months prior to screening.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Sequential Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: group 1: low dose
One intrathecal (IT) administration of SCM-010 at baseline visit
Biological: SCM-010
SCM-010 is comprised of adipose derived expanded mesenchymal cells (ADSC), suspended in Plasma-Lyte and intended for intrathecal (IT) administration.
Experimental: group 2: high dose
One intrathecal (IT) administration of SCM-010 at baseline visit
Biological: SCM-010
SCM-010 is comprised of adipose derived expanded mesenchymal cells (ADSC), suspended in Plasma-Lyte and intended for intrathecal (IT) administration.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Adverse Events (AEs) reported during the trial
Time Frame: 48 weeks
Safety data will be collected following the one IT administration of SCM-010 at baseline visit
48 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change in MRI scans from baseline
Time Frame: 24 weeks
Changes in lesions from baseline MRI scan.
24 weeks
Change from baseline in EDSS score
Time Frame: 24 weeks
The Expanded Disability Status Scale (EDSS) will be measured during the study. range of the scale 0-10
24 weeks
Time to Confirmed Disease Progression (CDP)
Time Frame: 24 weeks

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
24 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Stem Cell Medicine Ltd.

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Arnon Karni, Dr., Tel Aviv Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 1, 2024

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 1, 2025

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 1, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 30, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 3, 2018

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 4, 2018

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 18, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 16, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • SPMS-SCM-010

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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