Clinical trial Recruiting at 2 sites Phase 1 Interventional

Using stem cells from umbilical cords to treat lung diseases

Official title: Safety of Cultured Allogeneic Adult Umbilical Cord or Placental Derived Mesenchymal Stem Cell Intravenous Infusion for the Treatment of Pulmonary Diseases

Run by The Foundation for Orthopaedics and Regenerative Medicine · NCT05147688 · Data updated 2026-11-12

This study is testing if a single infusion of stem cells from umbilical cords can help people with lung diseases like asthma and COPD feel better and improve their health over time.

Quick facts

PhasePhase 1
Study typeInterventional
SexAll
Enrollment20 (estimated)
SponsorThe Foundation for Orthopaedics and Regenerative Medicine
Academic / other
Locations2 sites (Naples, Florida and 1 other locations)
StatusRecruiting
StartedDecember 1, 2021
Main results expectedDecember 2028
Study endsDecember 2028
Registry record updatedOctober 16, 2026
Trial IDNCT05147688 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates are individuals diagnosed with pulmonary diseases who are willing to provide informed consent.

Probably not a fit

Patients with active infections, cancers, or other serious health conditions may not benefit from this treatment.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This trial investigates the safety and efficacy of intravenous infusions of cultured allogeneic adult umbilical cord-derived mesenchymal stem cells (UC-MSCs) for patients with pulmonary diseases such as asthma and chronic obstructive pulmonary disease (COPD). Participants will receive a single infusion of 100 million UC-MSCs and will be monitored for safety and effectiveness over a period of up to 48 months. Evaluations will occur at multiple time points to assess the treatment's impact on their condition.

Why it matters

Potential benefit: If successful, this treatment could provide a novel therapeutic option for patients suffering from pulmonary diseases.

How similar studies have gone: While the use of stem cells for pulmonary diseases is an emerging field, this specific approach is relatively novel and has not been extensively tested in prior studies.

Who can join: the full rules

Show full inclusion / exclusion 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

Where it's running

  • Prodromos Stem Cell Institute
    Naples, Florida, United States
    Recruiting
  • Prodromos Stem Cell Institute
    Athens, Greece
    Recruiting

Study contacts

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How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.