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Recruiting NCT05147688

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

Phase I Interventional Pulmonary Disease Asthma Chronic Obstructive Pulmonary Disease

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: AlloRx.
Who it may be relevant to
Registry conditions: Pulmonary Disease, Asthma, Chronic Obstructive Pulmonary Disease. Basic parameters: No limits · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Antigua and Barbuda
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Safety of Cultured Allogeneic Adult Umbilical Cord Derived Mesenchymal Stem Cell Intravenous Infusion for the Treatment of Pulmonary Diseases

Overview

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

Detailed description

In this patient funded trial, patients with pulmonary disease will receive a single intravenous infusion of UC-MSCs. The total dose will be 100 million cells. Patients will be evaluated within one month pre treatment and at 1, 6, 12, 24, 36, and 48 months post treatment for safety and efficacy.

Interventions

  • Biological AlloRx
    cultured allogeneic adult umbilical cord derived mesenchymal stem cells

Primary outcome measures

  • Safety (adverse events) [Time frame: Four year follow-up]
Secondary outcome measures (2)
  • Efficacy: Forced vital capacity (FVC) [Time frame: Four year follow-up]
  • Efficacy: Pulmonary function test [Time frame: Four year follow-up]

Eligibility criteria

Inclusion criteria

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

Exclusion criteria

  • 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

Antigua and Barbuda · 1 center
  • Medical Surgical Associates Center — St John's

Publications

  • 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
  • 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
  • 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
  • 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

Identifiers

NCT: NCT05147688 · ATG-1-MSC-013

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗