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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
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
Awards & highlights
REGALS Trial 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.Check my eligibility
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.See study design
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.
REGALS Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
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.
REGALS Trial 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
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Combined assessment of function and survival (CAFS)
Treatment Limiting Toxicity (TLT)
Secondary outcome measures
ALS Functional Rating Scale-Revised (ALSFRS-R) Score
Amyotrophic Lateral Sclerosis Specific Quality of Life - Revised (ALSSQOL-R)
Handheld dynamometer (HHD)
+6 moreREGALS 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
Find a Location
Who is running the clinical trial?
Cellenkos, Inc.Lead Sponsor
4 Previous Clinical Trials
87 Total Patients Enrolled
Arthur Slutsky, MD MASc BAScStudy DirectorUniversity of Toronto
Neil Shneider, MD, PhDPrincipal InvestigatorColumbia University
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You need to have a score between 36 and 45 on a test called ALSFRSR at the beginning of the study.I am 18 years or older with ALS.I am not pregnant or breastfeeding.I have been diagnosed with ALS.My lung function, based on my age, sex, and height, is at least half of what is expected.You have a very low platelet count or other abnormal blood test results that make you unsuitable for the study.I am willing to follow all study procedures and cooperate with the research team.I have been on a stable dose of Riluzole, Edaravone, or Albrioza for at least 30 days.You have an infection that hasn't gotten better after seven days of treatment with the right antibiotics. The Protocol medical monitor will make the final decision about whether you can join the study.I have not taken any blood thinners, including low-dose aspirin, in the last 14 days.I haven't taken any experimental drugs or treatments recently.Your blood tests for clotting should be normal.My condition started less than 5 years ago.I haven't had cancer treatment in the last 5 years, except for cervical or skin cancer.
Research Study Groups:
This trial has the following groups:- Group 1: CK0803
- Group 2: Placebo
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Amyotrophic Lateral Sclerosis Patient Testimony for trial: Trial Name: NCT05695521 — Phase 1
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Does the protocol of this medical trial extend to those aged 75 and above?
"This trial is open to adult participants who are between 18 and 95 years old, in accordance with the eligibility parameters."
Answered by AI
Has CK0803 been ratified by the United States Food and Drug Administration?
"Due to limited data around safety and efficacy, CK0803 was rated a 1 on our internal scale. This is indicative of it being an early Phase 1 clinical trial."
Answered by AI
Who is qualified to take part in this research study?
"Prospective participants of this clinical trial must be diagnosed with ALS, between 18 and 95 years old. This research initiative is aiming to recruit 66 individuals."
Answered by AI
Are there still opportunities to join this medical research project?
"According to the data presented on clinicaltrials.gov, this trial has ceased recruiting patients as of January 23rd 2023. Despite no longer needing participants for this study, there are 518 other medical studies currently in need of volunteers."
Answered by AI
What results are investigators hoping to be able to demonstrate from this experiment?
"The primary outcome of this 24 week clinical trial is the Treatment Limiting Toxicity (TLT). Secondary objectives include tracking patient progress with the ALS Functional Rating Scale-Revised (ALSFRS-R) Score, Amyotrophic Lateral Sclerosis Specific Quality of Life - Revised (ALSSQOL-R), and Slow Vital Capacity (SVC). Each ALSSQOL-R item will be rated on a 0 to 10 point scale, while the ALSFRS-R score ranges from 0 to 48. The volume of air expired in complete expiration after maximal inspiration without forced or rapid effort will measure SVC."
Answered by AI
Who else is applying?
What state do they live in?
California
What site did they apply to?
Columbia University Irving Medical Center
What portion of applicants met pre-screening criteria?
Met criteria
How many prior treatments have patients received?
3+
Why did patients apply to this trial?
I am 68 female with bulbar palsy, I have lost my voice but no limb onset. I have the c9 mutation and have been in trial phase 2 for TPN-101 at uc Irvine where I’m treated.
PatientReceived 1 prior treatment
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