Evidence map›Paper›PMID 37633275›Full record

ArticleCell reports. Medicine2023

A phase I, first-in-human study to evaluate the safety and tolerability, pharmacokinetics, and pharmacodynamics of MRG-001 in healthy subjects.

Ali R Ahmadi, George Atiee, Bart Chapman, Laurie Reynolds, John Sun, Andrew M Cameron, Russell N Wesson, James F Burdick, Zhaoli Sun

4 registry-linked trialsAbstract readClinical Trial, Phase I
In one paragraph

Article in Cell reports. Medicine, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 4 registered trials, which are not on this map. Cited by 4 papers.

0numbers the graph read from it
0cells of the map it votes in
4citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT04646603 phase2unknown statusnot on this map

A Phase IIa, Adaptive, Double-Blind, Randomized, Placebo-Controlled, Multi-Center Study in Hospitalized Patients Infected With Severe and Critical SARS-CoV-2 to Assess the Safety, Pharmacokinetics, Pharmacodynamics and Efficacy of MRG-001

TypeinterventionalSponsorMedRegen LLCRan2021 to 2022Enrolled40ConditionsCOVID-19, ARDS, Human, Stem Cells, RegenerationArmsMRG-001, Placebo
NCT06307522 phase2not yet recruitingnot on this mapstarted 2024, after this paper: background citation

An Open-Label, Dose-Escalation Study to Assess the Safety, Pharmacokinetics and Pharmacodynamics of MRG-001 in Patients With Alcoholic Hepatitis

TypeinterventionalSponsorMedRegen LLCRan2024 to 2026Enrolled32ConditionsAlcoholic Hepatitis, Acute Alcoholic HepatitisArmsMRG-001
NCT06308926 phase2not yet recruitingnot on this mapstarted 2024, after this paper: background citation

A Phase IIa, Double-Blind, Randomized, Multi-Center Study Comparing MRG-001 to Placebo in Patients With Acute Respiratory Distress Syndrome

TypeinterventionalSponsorMedRegen LLCRan2024 to 2026Enrolled60ConditionsAcute Respiratory Distress Syndrome, Respiratory Failure, Respiratory Distress Syndrome, Respiratory Tract DiseasesArmsMRG-001 (Low-dose), MRG-001 (High-dose), Placebo
NCT06315608 phase2not yet recruitingnot on this mapstarted 2025, after this paper: background citation

An Open-Label, Proof of Concept Study to Assess the Safety, Pharmacokinetics and Pharmacodynamics of MRG-001 in Patients With Amyotrophic Lateral Sclerosis

TypeinterventionalSponsorMedRegen LLCRan2025 to 2026Enrolled10ConditionsAmyotrophic Lateral Sclerosis, Lou Gehrig Disease, Motor Neuron Disease, Motor Neuron AtrophyArmsMRG-001
3 · Its place in the literature

Who cites it

4 citing papers in PubMed.

  1. Article
  2. Review
  3. Review
  4. Induction of Skin Allograft Chimerism by Pharmacological Mobilization of Endogenous Bone Marrow-Derived Stem Cells.Journal of burn care & research : official publication of the American Burn Association · 2024
    Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

9 authors.

Ali R AhmadiMedRegen LLC, Baltimore, MD, USA. Electronic address: ahmadi@medregenco.com.
George AtieeICON PLC, San Antonio, TX, USA.
Bart ChapmanICON PLC, San Antonio, TX, USA.
Laurie ReynoldsICON PLC, San Antonio, TX, USA.
John SunMedRegen LLC, Baltimore, MD, USA.
Andrew M CameronDepartment of Surgery, Johns Hopkins School of Medicine, Baltimore, MD 21205, USA.
Russell N WessonDepartment of Surgery, Johns Hopkins School of Medicine, Baltimore, MD 21205, USA.
James F BurdickMedRegen LLC, Baltimore, MD, USA.
Zhaoli SunDepartment of Surgery, Johns Hopkins School of Medicine, Baltimore, MD 21205, USA.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Preclinical studies demonstrate that pharmacological mobilization and recruitment of endogenous bone marrow stem cells and immunoregulatory cells by a fixed-dose drug combination (MRG-001) improves wound healing, promotes tissue regeneration, and prevents allograft rejection. In this phase I, first-in-human study, three cohorts receive subcutaneous MRG-001 or placebo, every other day for 5 days. The primary outcome is safety and tolerability of MRG-001. Fourteen subjects received MRG-001 and seven received a placebo. MRG-001 is safe over the selected dose range. There are no clinically significant laboratory changes. The intermediate dose group demonstrates the most significant white blood cell, stem cell, and immunoregulatory cell mobilization. PBMC RNA sequencing and gene set enrichment analysis reveal 31 down-regulated pathways in the intermediate MRG-001 dose group compared with no changes in the placebo group. MRG-001 is safe across all dose ranges. MRG-001 may be a clinically useful therapy for immunoregulation and tissue regeneration (ClinicalTrials.gov: NCT04646603).

Indexed as

Leukocytes, MononuclearStem CellsHealthy VolunteersHumansTransplantation, Homologousclinical trialhealthy volunteersMRG-001pharmacodynamicspharmacokineticsphase Iplerixaforsafetystem cellstacrolimus

Identifiers

PMID37633275
PMCPMC10518600

What OpenQuestion holds

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LicenceCC BY
Read underepoch 390

Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.