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Trial record 1 of 1 for:    SCM-010
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Study to Assess the Safety and Efficacy of an IT Administration of SCM-010 in SPMS

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ClinicalTrials.gov Identifier: NCT03696485
Recruitment Status : Not yet recruiting
First Posted : October 4, 2018
Last Update Posted : October 27, 2022
Sponsor:
Information provided by (Responsible Party):
Stem Cell Medicine Ltd.

Tracking Information
First Submitted Date  ICMJE September 30, 2018
First Posted Date  ICMJE October 4, 2018
Last Update Posted Date October 27, 2022
Estimated Study Start Date  ICMJE February 1, 2023
Estimated Primary Completion Date February 1, 2024   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 14, 2018)
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
Original Primary Outcome Measures  ICMJE
 (submitted: October 3, 2018)
Adverse Events (AEs) reported during the trial [ Time Frame: 48 weeks ]
Safety data will be collected following the one IT administration of MSC at baseline visit
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: October 3, 2018)
  • Change in MRI scans from baseline [ Time Frame: 24 weeks ]
    Changes in lesions from baseline MRI scan.
  • 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
  • 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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study to Assess the Safety and Efficacy of an IT Administration of SCM-010 in SPMS
Official Title  ICMJE 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)
Brief 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.
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  ICMJE Interventional
Study Phase  ICMJE Phase 1
Phase 2
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Secondary Progressive Multiple Sclerosis (SPMS)
Intervention  ICMJE Biological: SCM-010
SCM-010 is comprised of adipose derived expanded mesenchymal cells (ADSC), suspended in Plasma-Lyte and intended for intrathecal (IT) administration.
Study Arms  ICMJE
  • Experimental: group 1: low dose
    One intrathecal (IT) administration of SCM-010 at baseline visit
    Intervention: Biological: SCM-010
  • Experimental: group 2: high dose
    One intrathecal (IT) administration of SCM-010 at baseline visit
    Intervention: Biological: SCM-010
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Not yet recruiting
Estimated Enrollment  ICMJE
 (submitted: October 3, 2018)
12
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE February 1, 2024
Estimated Primary Completion Date February 1, 2024   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 60 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Arnon Karni, Dr. +972-36974380 arnonk@tlvmc.gov.il
Listed Location Countries  ICMJE Israel
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03696485
Other Study ID Numbers  ICMJE SPMS-SCM-010
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party Stem Cell Medicine Ltd.
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Stem Cell Medicine Ltd.
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Arnon Karni, Dr. Tel Aviv Medical Center
PRS Account Stem Cell Medicine Ltd.
Verification Date October 2022

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP