- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03696485
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
Withdrawn
Intervention / Treatment
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
Interventional
Phase
- 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 Locations
-
-
-
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
Ages Eligible for Study
18 years to 60 years (Adult)
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- 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.
- 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.
Exclusion Criteria:
- 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).
- 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.
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 |
Intervention / Treatment |
---|---|
Experimental: group 1: low dose
One intrathecal (IT) administration of SCM-010 at baseline visit
|
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
|
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
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
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
Investigators
- 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)
February 1, 2024
Primary Completion (Estimated)
February 1, 2025
Study Completion (Estimated)
February 1, 2025
Study Registration Dates
First Submitted
September 30, 2018
First Submitted That Met QC Criteria
October 3, 2018
First Posted (Actual)
October 4, 2018
Study Record Updates
Last Update Posted (Actual)
April 18, 2024
Last Update Submitted That Met QC Criteria
April 16, 2024
Last Verified
April 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Pathologic Processes
- Nervous System Diseases
- Immune System Diseases
- Neoplasms
- Demyelinating Autoimmune Diseases, CNS
- Autoimmune Diseases of the Nervous System
- Demyelinating Diseases
- Autoimmune Diseases
- Disease Attributes
- Neoplastic Processes
- Chronic Disease
- Multiple Sclerosis
- Multiple Sclerosis, Chronic Progressive
- Sclerosis
- Neoplasm Metastasis
Other Study ID 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.
Clinical Trials on Secondary Progressive Multiple Sclerosis (SPMS)
-
University College, LondonLondon School of Hygiene and Tropical Medicine; The Leeds Teaching Hospitals... and other collaboratorsActive, not recruitingSecondary Progressive Multiple Sclerosis (SPMS)United Kingdom
-
Novartis PharmaceuticalsCompletedSecondary Progressive Multiple Sclerosis (SPMS)Japan
-
BayerCompletedSecondary Progressive Multiple Sclerosis (SPMS) | Relapsing Remitting Multiple Sclerosis (RRMS)Portugal
-
University Hospital, Basel, SwitzerlandSwiss National Science FoundationRecruitingMultiple Sclerosis (MS) | Relapsing-remitting Multiple Sclerosis (RRMS) | Secondary-progressive Multiple Sclerosis (SPMS) | Primary Progressive Multiple Sclerosis (PPMS)Switzerland
-
Casa Sollievo della Sofferenza IRCCSNeurocenter of Southern Switzerland; Associazione Revert ONLUS; Fondazione Cellule...CompletedSecondary-progressive Multiple SclerosisItaly, Switzerland
-
Tiziana Life Sciences LTDWithdrawnMultiple Sclerosis | Primary Progressive Multiple Sclerosis | Secondary Progressive Multiple Sclerosis
-
BioMS Technology Corp.TerminatedMultiple Sclerosis, Secondary Progressive
-
State University of New York at BuffaloCompletedSecondary-progressive Multiple SclerosisUnited States
-
Novartis PharmaceuticalsActive, not recruitingRelapsing-remitting Multiple Sclerosis | Active Secondary Progressive Multiple SclerosisJapan
-
University of UtahCompletedMultiple Sclerosis | Multiple Sclerosis, Secondary Progressive | Secondary Progressive Multiple SclerosisUnited States
Clinical Trials on SCM-010
-
Michigan State UniversityMassachusetts General Hospital; University of Michigan; Saint Joseph Mercy Health... and other collaboratorsCompleted
-
SCM Lifescience Co., LTD.Active, not recruitingChronic Graft-versus-host-diseaseKorea, Republic of
-
SCM Lifescience Co., LTD.CompletedDermatitis, AtopicKorea, Republic of
-
SCM Lifescience Co., LTD.CompletedPancreatitis, AcuteKorea, Republic of
-
University of Texas at AustinBaylor College of Medicine; University of Kansas Medical CenterCompleted
-
Seoul National University HospitalCompletedCatheterization | Ipsilateral Nipple | Internal Jugular VeinKorea, Republic of
-
Icahn School of Medicine at Mount SinaiNational Institute of Mental Health (NIMH)Enrolling by invitationFirst Episode Psychosis (FEP) | Clinical High Risk for Psychosis (CHR)United States
-
Contera PharmaBukwang PharmaceuticalActive, not recruitingDyskinesiasFrance, Germany, Italy, Korea, Republic of, Spain
-
Synthetic Biologics Inc.CompletedIrritable Bowel Syndrome With Constipation (IBS-C)United States
-
Tianjin Chasesun Pharmaceutical Co., LTDEnrolling by invitation