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MRG-001 in Patients With Amyotrophic Lateral Sclerosis

ConditionsAmyotrophic Lateral SclerosisLou Gehrig DiseaseMotor Neuron DiseaseMotor Neuron Atrophy
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorMedRegen LLC

About this trial

The proposed study is an Open-Label, Single-Dose Study to Assess the Safety, and Pharmacodynamics (PD) signals of MRG-001 in Patients with Amyotrophic Lateral Sclerosis (ALS). MRG-001 will be administered subcutaneously 3 times per week for 2 weeks. This cycle will be repeated for 3 months. In total, patients are expected to receive 18 injections over the span of 3 months.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Able to provide written informed consent (either from patient or patient's legally acceptable representative and complying with study procedures, in the PI's opinion.

Male or female patients between 18-75 years.

Sporadic or familial ALS diagnosed as clinically possible, probable, lab-supported probable, or definite ALS defined by revised El Escorial criteria.

Time since onset of weakness due to ALS ≤ 48 months at the time of the Screening Visit

Disqualifiers

Participation in another interventional clinical trial (drug or device) within 30 days of Screening and at any time during the study.

Lung: Receiving supplemental home oxygen therapy at baseline for pre-existing medical condition (other than COVID-19), as documented in medical record.

Heart: Pre-existing congestive heart failure defined as an ejection fraction <20% as documented in the medical record. Clinically significant ventricular arrhythmias (ventricular tachycardia, ventricular fibrillation), unstable angina, myocardial infarction (past 3 months), heart and coronary vessel surgery (past 3 months), significant valvular heart disease, uncontrolled arterial hypertension with systolic blood pressure >180 mm Hg and diastolic blood pressure >110 mm Hg.

Renal: End-stage renal disease requiring renal replacement therapy or creatinine clearance <50 mL/min.

Trial design

Design model

Single group

Treatments tested in this trial

  • MRG-001

    Drug

    MRG-001 is a clear liquid solution for subcutaneous injection

Treatment groups

10 Participants
are divided into 1 treatment group
Group A: MRG-001 (0.01 mL/kg)Experimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Assessment of Treatment-Emergent Adverse Events

Assess the safety and tolerability of MRG-001 in patients with Amyotrophic Lateral Sclerosis (ALS) as determined by the absence of serious adverse events (SAE)

Time frame
3 Months

Secondary outcomes

1

Stem Cell Mobilization

The absolute change in numbers of CD34+ hematopoetic stem cells as measured by flow cytometry

Time frame
24 hours
2

Regulatory T-cell Mobilization

The absolute change in numbers of FOXP3+ regulatory T-cells as measured by flow cytometry

Time frame
24 hours
3

Change in Disease Progression

Change in disease severity over time as measured by the ALS Functional Rating Scale-Revised (ALSFRS-R) at Baseline, 1, 2 and 3 months. Each type of function is scored from 4 (normal) to 0 (no ability), with a maximum total score of 48 and a minimum total score of 0. Patients with higher scores have more physical function. Positive data means the reversal of ALS disease, negative data means disease progression, zero means stabilization of disease.

Time frame
3 Months

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

MedRegen LLC

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: