Safety of Cultured Allogeneic Adult Umbilical Cord Derived Mesenchymal Stem Cells for Pulmonary Diseases

NCT05147688 | Recruiting Phase 1 FDA Drug

• 1 other identifier: ATG-1-MSC-013
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

This trial will study the safety and efficacy of intravenous infusion of cultured allogeneic adult umbilical cord derived mesenchymal stem cells for the treatment of Pulmonary Diseases

Conditions

Pulmonary Disease; Asthma; Chronic Obstructive Pulmonary Disease

Keywords

Pulmonary Disease; Asthma; stem cell treatment; Chronic Obstructive Pulmonary Disease

Outcome Measures

Primary Outcomes (1)

• Safety (adverse events)

  Clinical monitoring of possible adverse events or complications

  Four year follow-up

Secondary Outcomes (2)

• Efficacy: Forced vital capacity (FVC)

  Four year follow-up

• Efficacy: Pulmonary function test

  Four year follow-up

Study Arms (1)

Treatment Group

EXPERIMENTAL

Single intravenous infusion of 100 million cells

Biological: AlloRx

Interventions

AlloRx BIOLOGICAL

cultured allogeneic adult umbilical cord derived mesenchymal stem cells

Treatment Group

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosis of pulmonary disease
• Understanding and willingness to sign a written informed consent document

You may not qualify if:

• Active infection
• Active cancer
• Chronic multisystem organ failure
• Pregnancy
• Clinically significant Abnormalities on pre-treatment laboratory evaluation
• Medical condition that would (based on the opinion of the investigator) compromise patient's safety.
• Continued drug abuse
• Pre-menopausal women not using contraception
• Previous organ transplant
• Hypersensitivity to sulfur

Sponsors & Collaborators

• The Foundation for Orthopaedics and Regenerative Medicine: lead

Study Sites (1)

Medical Surgical Associates Center

St John's, Antigua and Barbuda

RECRUITING

Related Publications (4)

• Averyanov A, Koroleva I, Konoplyannikov M, Revkova V, Lesnyak V, Kalsin V, Danilevskaya O, Nikitin A, Sotnikova A, Kotova S, Baklaushev V. First-in-human high-cumulative-dose stem cell therapy in idiopathic pulmonary fibrosis with rapid lung function decline. Stem Cells Transl Med. 2020 Jan;9(1):6-16. doi: 10.1002/sctm.19-0037. Epub 2019 Oct 15.

  PMID: 31613055 BACKGROUND

• Fishman JE, Kim GJ, Kyeong NY, Goldin JG, Glassberg MK. Intravenous stem cell dose and changes in quantitative lung fibrosis and DLCO in the AETHER trial: a pilot study. Eur Rev Med Pharmacol Sci. 2019 Sep;23(17):7568-7572. doi: 10.26355/eurrev_201909_18877.

  PMID: 31539148 BACKGROUND

• Cruz FF, Borg ZD, Goodwin M, Sokocevic D, Wagner D, McKenna DH, Rocco PR, Weiss DJ. Freshly thawed and continuously cultured human bone marrow-derived mesenchymal stromal cells comparably ameliorate allergic airways inflammation in immunocompetent mice. Stem Cells Transl Med. 2015 Jun;4(6):615-24. doi: 10.5966/sctm.2014-0268. Epub 2015 Apr 29.

  PMID: 25925837 BACKGROUND

• Trzil JE, Masseau I, Webb TL, Chang CH, Dodam JR, Liu H, Quimby JM, Dow SW, Reinero CR. Intravenous adipose-derived mesenchymal stem cell therapy for the treatment of feline asthma: a pilot study. J Feline Med Surg. 2016 Dec;18(12):981-990. doi: 10.1177/1098612X15604351. Epub 2015 Sep 17.

  PMID: 26384398 BACKGROUND

MeSH Terms

Conditions

Lung Diseases; Asthma; Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Respiratory Tract Diseases; Bronchial Diseases; Lung Diseases, Obstructive; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Chadwick Prodromos, MD

  The Foundation for Orthopaedics and Regenerative Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 29, 2021
• First Posted: December 7, 2021
• Study Start: December 1, 2021
• Primary Completion: December 1, 2025
• Study Completion: December 1, 2025
• Last Updated: April 17, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

AN (1)