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RecruitingNCT05147688Updated Oct 16, 2026

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

A Phase 1 interventional study of cultured allogeneic adult umbilical cord or placental derived mesenchymal stem cells in Pulmonary Disease, Asthma and Chronic Obstructive Pulmonary Disease, sponsored by The Foundation for Orthopaedics and Regenerative Medicine. Recruiting at 2 sites in 2 countries. Per ClinicalTrials.gov, last updated 2026-10-16.

Sponsored by The Foundation for Orthopaedics and Regenerative Medicine · Phase 1, Interventional, and Treatment

From the registry’s dates

  • Started Dec 2021; still recruiting 4 years 11 months later.
Updated Oct 16, 2026First sites in Greece and United StatesNo longer in Antigua and Barbuda+7 moreGo to Updates ↓
Phase
Phase 1
Study type
Interventional
Enrollment
20
Allocation
Not applicable
Sex
All
01

Study summary

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

Read the detailed description

In this patient funded trial, patients with pulmonary disease will receive a single intravenous infusion of 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.

02

Conditions studied

  • Pulmonary Disease
  • Asthma
  • Chronic Obstructive Pulmonary Disease

Keywords

  • Pulmonary Disease
  • Asthma
  • stem cell treatment
  • Chronic Obstructive Pulmonary Disease
03

In context

Lung Diseases

1,158 studies on the registry are indexed under Lung Diseases; 182 are open to participants now.

This study's planned enrollment of 20 is below the median of 70 across 663 interventional studies indexed under Lung Diseases.

Browse Lung Diseases studies →

Lead sponsor

The Foundation for Orthopaedics and Regenerative Medicine is the lead sponsor of 33 studies on the registry; 20 are open to participants now.

Of its 6 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • Active infection
  • Active cancer
  • Chronic multisystem organ failure
  • Pregnancy
  • 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
  • Previous organ transplant
  • to sulfur
Terms in these criteria, in plain language(4)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Clinically significant

Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.

Contraception

Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.

Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.

Hypersensitivity

An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.

05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
20 participants (estimated)

Study arms

  • Experimental
    Treatment Group

    Single intravenous infusion

    Biological: cultured allogeneic adult umbilical cord or placental derived mesenchymal stem cells

Interventions

  • Biologicalcultured allogeneic adult umbilical cord or placental derived mesenchymal stem cells

    cultured allogeneic adult umbilical cord or placental derived mesenchymal stem cells

06

What researchers measure

Primary outcomes

  1. Safety (adverse events)

    Clinical monitoring of possible adverse events or complications

    Time frame: Four year follow-up

Secondary outcomes

  1. Efficacy: Forced vital capacity (FVC)

    It will be completed for each follow up point.

    Time frame: Four year follow-up

  2. Efficacy: Pulmonary function test

    It will be completed for each follow up point.

    Time frame: Four year follow-up

07

Study locations

2 of 2 sites recruiting
08

References and documents

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. PubMed 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. PubMed 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. PubMed 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. PubMed 26384398 ↗
09

Updates

1 registry update since Sep 25, 2026
Sites
2 sites added, 1 site removed — first sites in Greece and United States; no longer in Antigua and Barbuda
Show 2 added (1 United States, 1 Greece)
  • Prodromos Stem Cell Institute · Naples, United States
  • Prodromos Stem Cell Institute · Athens, Greece
Show 1 removed
  • Medical Surgical Associates Center · St. John's, Antigua and Barbuda
Oct 16, 2026
Primary completion
Dec 2025→Dec 2028
Oct 16, 2026
Study completion
Dec 2025→Dec 2028
Oct 16, 2026
Interventions
Added Biological: cultured allogeneic adult umbilical cord or placental derived mesenchymal stem cells; removed Biological: AlloRx
Oct 16, 2026
Contact
Study contact now listed: added c•••@thepsci.com · •••6810. See the current contact
Oct 16, 2026
Title
Safety of Cultured Allogeneic Adult Umbilical Cord or Placental Derived Mesenchymal Stem Cells for Pulmonary Diseases
Oct 16, 2026
Show all 1 update
  1. Oct 16, 2026
    2 sites added, 1 site removed — first sites in Greece and United States; no longer in Antigua and Barbuda
    Show 2 added (1 United States, 1 Greece)
    • Prodromos Stem Cell Institute · Naples, United States
    • Prodromos Stem Cell Institute · Athens, Greece
    Show 1 removed
    • Medical Surgical Associates Center · St. John's, Antigua and Barbuda
    Primary completion Dec 2025→Dec 2028
    Study completion Dec 2025→Dec 2028
    Interventions Added Biological: cultured allogeneic adult umbilical cord or placental derived mesenchymal stem cells; removed Biological: AlloRx
    Contact Study contact now listed: added c•••@thepsci.com · •••6810. See the current contact
    Title Safety of Cultured Allogeneic Adult Umbilical Cord or Placental Derived Mesenchymal Stem Cells for Pulmonary Diseases
    + 4 other changes: index terms, verification date, description and data sharing statement

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT05147688
Lead sponsor
The Foundation for Orthopaedics and Regenerative Medicine
Responsible party
Sponsor
First posted
Dec 7, 2021
Start date
Dec 1, 2021
Primary completion
Dec 2028 (estimated)
Completion
Dec 2028 (estimated)
Last update
Oct 16, 2026

Study contacts

Chadwick Prodromos, MD
Contact
care@thepsci.com
847-699-6810 ext. 202

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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