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Active, Not Recruiting

NCT Number: NCT06889857

Safety and Efficacy of Intravenous Administration of SHED-CM for ALS

This study evaluates the safety and efficacy of Stem Cell from Human Exfoliated Deciduous teeth Conditioned Media (SHED-CM) in patients with Amyotrophic Lateral Sclerosis (ALS), using the Japanese version of the revised ALS Functional Rating Scale (ALSFRS-R) as an indicator.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Amyotrophic Lateral Sclerosis Central Nervous System Diseases Metabolic Diseases Motor Neuron Disease Nervous System Diseases Neurodegenerative Diseases Neuromuscular Diseases Nutritional and Metabolic Diseases Proteostasis Deficiencies Spinal Cord Diseases TDP-43 Proteinopathies

Age range

20 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Early Phase 1

Primary location

Hitonowa Medical

Chiyoda City, Tokyo, 102-0085, Japan

About this study

The main objective of this study is to evaluate the safety and efficacy of Stem Cell from Human Exfoliated Deciduous teeth Conditioned Media in patients with Amyotrophic Lateral Sclerosis (ALS), Particular focus will be placed on improving neurological function, slowing the rate of symptom progression, and improving the patient's quality of life.

What are the advantages of this therapy over standard therapy? and for which patients it is most effective ?

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Patients who meet the following inclusion criteria (1) to (6) at the time of Informed consent

  • Patients who have provided written informed consent to participate in the study.
  • Patients who are at least 20 years of age at the time of obtaining informed consent.
  • Patients diagnosed with isolated or familial ALS and diagnosed as definite, the probable, or the probable laboratory-supported by updated Awaji criteria.
  • Patients with severity 1 or 2 on ALS severity criteria.
  • Outpatients.
  • Patients residing in Japan who can communicate in Japanese.

Exclusion criteria

Patients who do not meet any of the exclusion criteria (1) to (15) at the time of Informed consent

  • Patients with a tracheostomy
  • Patients with a history of non-invasive respiratory support
  • Patients with a percent FVC of 60 or less
  • Patients with chronic obstructive pulmonary disease (COPD)
  • Patients newly treated with edaravone or riluzole (oral) within 4 weeks prior to Informed consent
  • Patients receiving HAL medical leg type treatment
  • Patients receiving intravenous edaravone
  • Patients with cognitive impairment
  • Pregnant women or patients who may be pregnant
  • Patients with serious respiratory, cardiovascular, hepatic, or renal disease
  • Patients with malignant tumors
  • Patients with uncontrolled infection
  • Patients who have participated in other clinical trials within 12 weeks prior to obtaining consent
  • Patients with a history of drug allergy or severe allergic disease (e.g., anaphylactic shock) or concomitant history
  • Patients who are deemed inappropriate to participate in the study by the principal investigator or research coordinator.

Treatment and study plan

The study drug is SHED-CM manufactured by U-Factor

Biological

This study will involve informed consent, a 12-week observation period, a 12-week study drug administration period, and a 4-week follow-up period.

Primary outcomes

  1. All Adverse Events

    Time frame: Immediately after each administration and up to 4 weeks post-treatment

    This measure will check the total number of adverse events (AEs) reported during the study, categorized by CTCAE Ver 5.0 .

  2. Number of Clinically Significant Changes in Laboratory Test Results

    Time frame: Baseline, Week 4, Week 8, Week 12, and at follow-up (Week 16).

    This measure will track the number of events where clinically significant abnormalities are detected in laboratory test parameters, including blood count, biochemistry, and coagulation function tests. Changes from baseline to follow-up are evaluated based on predefined clinical thresholds.

  3. Number of Clinically Significant Changes in Vital Signs

    Time frame: Baseline, Week 4, Week 8, Week 12, and at follow-up (Week 16).

    This measure will evaluate the number of events where clinically significant changes in vital signs occur. Parameters include systolic blood pressure, diastolic blood pressure, pulse rate, body temperature, and SpO2. Each event will be assessed at two time points: immediately after treatment and after follow-up session, comparing values to baseline.

  4. Safety assessment during the study period: Adverse events - Self- and other findings

    Time frame: Immediately after each administration and up to 4 weeks post-treatment

    Medical examination, subjective findings, Other findings

Secondary outcomes

  1. Efficacy assessment: ALSFRS-R

    Time frame: Change from baseline ALSFRS-R at follow-up session

    The revised ALS Functional Rating Scale in ALS Patients. This scale is scored from 0 to 48, the higher the score the better.

  2. Efficacy assessment: %FVC

    Time frame: Change from baseline %FVC at follow-up session

    % forced vital capacity in ALS Patients

  3. Efficacy assessment: grip strength

    Time frame: Change from baseline grip strength at follow-up session

    grip strength in ALS Patients

Sponsors and collaborators

Lead sponsor

Hitonowa Medical

Other

Collaborators

  • U-Factor Co.,Ltd.

Registry information

Acronym: SCA202401

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Mar 21, 2025
Registry last updated
Sep 15, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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