Evaluating a new stem cell therapy for ALS

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

This study is testing a new stem cell therapy to see if it can help people with ALS feel better and slow down their symptoms.

Quick facts

• Phase: EARLY_PHASE1
• Study type: Interventional
• Enrollment: 10 (estimated)
• Ages: 20 Years and up
• Sex: All
• Sponsor: Hitonowa Medical (other)
• Locations: 1 site (Chiyoda, Tokyo)
• Trial ID: NCT06889857 on ClinicalTrials.gov

What this trial studies

This study assesses the safety and efficacy of Stem Cell from Human Exfoliated Deciduous teeth Conditioned Media (SHED-CM) in patients diagnosed with Amyotrophic Lateral Sclerosis (ALS). The research focuses on improving neurological function, slowing symptom progression, and enhancing the quality of life for participants. The Japanese version of the revised ALS Functional Rating Scale (ALSFRS-R) will be used to measure outcomes. Participants will receive intravenous administration of SHED-CM manufactured by U-Factor.

Who should consider this trial

Good fit: Ideal candidates for this study are Japanese-speaking adults aged 20 and older diagnosed with isolated or familial ALS at severity levels 1 or 2.

Not a fit: Patients with advanced respiratory issues or those recently treated with certain ALS medications may not benefit from this study.

Why it matters

Potential benefit: If successful, this therapy could provide a novel treatment option that improves neurological function and quality of life for ALS patients.

How similar studies have performed: While this approach is innovative, similar studies exploring stem cell therapies for ALS have shown promise, but results are still emerging.

Eligibility criteria

Inclusion Criteria:

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

1. Patients who have provided written informed consent to participate in the study.
2. Patients who are at least 20 years of age at the time of obtaining informed consent.
3. Patients diagnosed with isolated or familial ALS and diagnosed as definite, the probable, or the probable laboratory-supported by updated Awaji criteria.
4. Patients with severity 1 or 2 on ALS severity criteria.
5. Outpatients.
6. 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

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

Where this trial is running

Chiyoda, Tokyo

• Hitonowa Medical — Chiyoda, Tokyo, Japan (RECRUITING)

Study contacts

• Study coordinator: Yasuhiro Seta

Conditions: Amyotrophic Lateral Sclerosis, ALS - Amyotrophic Lateral Sclerosis, Stem Cells, Conditioned Medium, Therapy, Safety, Regenerative Medicine