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

NCT03696485 | Withdrawn Phase 1 DMC

• 1 other identifier: SPMS-SCM-010
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Secondary Progressive Multiple Sclerosis (SPMS)

Keywords

Secondary Progressive Multiple Sclerosis (SPMS), safety

Outcome Measures

Primary Outcomes (1)

• Adverse Events (AEs) reported during the trial

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

  48 weeks

Secondary Outcomes (3)

• Change in MRI scans from baseline

  24 weeks

• Change from baseline in EDSS score

  24 weeks

• Time to Confirmed Disease Progression (CDP)

  24 weeks

Study Arms (2)

group 1: low dose

EXPERIMENTAL

One intrathecal (IT) administration of SCM-010 at baseline visit

Biological: SCM-010

group 2: high dose

EXPERIMENTAL

One intrathecal (IT) administration of SCM-010 at baseline visit

Biological: SCM-010

Interventions

SCM-010 BIOLOGICAL

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

group 1: low dose; group 2: high dose

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Stem Cell Medicine Ltd.: lead

Study Sites (1)

Tel Aviv Medical Center

Tel Aviv, Israel

Location

MeSH Terms

Conditions

Multiple Sclerosis, Chronic Progressive

Condition Hierarchy (Ancestors)

Multiple Sclerosis; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Arnon Karni, Dr.

  Tel Aviv Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 30, 2018
• First Posted: October 4, 2018
• Study Start: February 1, 2024
• Primary Completion: February 1, 2025
• Study Completion: February 1, 2025
• Last Updated: April 18, 2024

Record last verified: 2024-04

Locations

IL (1)