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Cell Therapy

Regulatory T Cells for ALS (REGALS Trial)

Phase 1

Recruiting

Led By Neil Shneider, MD, PhD

Research Sponsored by Cellenkos, Inc.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Adult ALS subjects (≥18 years of age)

Diagnosis of ALS, according to the Revised El Escorial Criteria for ALS

Must not have

Female subjects who are pregnant or currently breastfeeding

Antiplatelet or anticoagulant therapy within the 14 days prior to Day 1 or anticipated use during the study, including but not limited to daily aspirin including low dose aspirin (defined as ≤ 150 mg/day), clopidogrel, dipyridamole, warfarin, dabigatran, rivaroxaban and apixaban

Timeline

Screening 3 weeks

Treatment Varies

Follow Up each measured at baseline and at weeks 5, 8, 12 and/or 13, 16, 20, 24 and/or 25, 36 and 48 from first infusion and/or at eot12 months

Summary

This trial tests a potential new treatment for ALS using cells from umbilical cord blood to see if it is safe and effective.

Who is the study for?

This trial is for adults diagnosed with ALS within the last 5 years, who meet specific criteria (Revised El Escorial Criteria). They must not be on certain medications or have participated in other trials recently. Stable doses of Riluzole, Edaravone, or Albrioza are required if used. Participants need to agree to contraception during and after the study.

What is being tested?

The trial tests CK0803 cells derived from umbilical cord blood as a treatment for ALS. It starts with a safety phase for 6 patients followed by a larger double-blind phase where participants randomly receive either CK0803 or an inactive substance without knowing which one they get.

What are the potential side effects?

As this is an early-phase trial primarily assessing safety, potential side effects are being investigated but may include immune reactions due to cell transplantation and typical risks associated with infusion procedures.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am 18 years or older with ALS.

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I have been diagnosed with ALS.

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My lung function, based on my age, sex, and height, is at least half of what is expected.

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My condition started less than 5 years ago.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am not pregnant or breastfeeding.

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I have not taken any blood thinners, including low-dose aspirin, in the last 14 days.

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I haven't taken any experimental drugs or treatments recently.

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I haven't had cancer treatment in the last 5 years, except for cervical or skin cancer.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ each measured at baseline and at weeks 5, 8, 12 and/or 13, 16, 20, 24 and/or 25, 36 and 48 from first infusion and/or at eot12 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~each measured at baseline and at weeks 5, 8, 12 and/or 13, 16, 20, 24 and/or 25, 36 and 48 from first infusion and/or at eot12 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and each measured at baseline and at weeks 5, 8, 12 and/or 13, 16, 20, 24 and/or 25, 36 and 48 from first infusion and/or at eot12 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Combined assessment of function and survival (CAFS)

Treatment Limiting Toxicity (TLT)

Secondary study objectives

ALS Functional Rating Scale-Revised (ALSFRS-R) Score

Amyotrophic Lateral Sclerosis Specific Quality of Life - Revised (ALSSQOL-R)

Handheld dynamometer (HHD)

+6 more

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: CK0803Experimental Treatment1 Intervention

CK0803 (cryopreserved, allogeneic, cord blood derived T regulatory cells that express neurotropic homing markers) will be administered intravenously Dose: 100 million Treg cells (fixed dose) Dose regimen: * Induction: one infusion every 7 days (+/-3) x 4 doses * Consolidation: one infusion every 28 days (+/-3) x 5 doses

Group II: PlaceboPlacebo Group1 Intervention

Excipient

0 / 8Eligibility criteria met