Safety of Cultured Allogeneic Adult Umbilical Cord Derived Mesenchymal Stem Cell Intravenous Infusion for IPF
1 other identifier
interventional
20
1 country
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 Idiopathic pulmonary fibrosis
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_1
Started Jul 2022
Typical duration for phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 17, 2021
CompletedFirst Posted
Study publicly available on registry
August 23, 2021
CompletedStudy Start
First participant enrolled
July 3, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2025
CompletedApril 17, 2025
April 1, 2025
3.3 years
August 17, 2021
April 14, 2025
Conditions
Keywords
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: Oxygen saturation test
Four year follow-up
Study Arms (1)
Treatment Group
EXPERIMENTALSingle intravenous infusion of 100 million cells
Interventions
cultured allogeneic adult umbilical cord derived mesenchymal stem cells
Eligibility Criteria
You may qualify if:
- Diagnosis of Idiopathic Pulmonary Fibrosis
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Medical Surgical Associates Center
St John's, Antigua and Barbuda
Related Publications (2)
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: 31613055BACKGROUNDFishman 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: 31539148BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Chadwick Prodromos, MD
The Foundation for Orthopaedics and Regenerative Medicine
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
August 17, 2021
First Posted
August 23, 2021
Study Start
July 3, 2022
Primary Completion
November 1, 2025
Study Completion
November 1, 2025
Last Updated
April 17, 2025
Record last verified: 2025-04