Safety of Cultured Allogeneic Adult Umbilical Cord Derived Mesenchymal Stem Cell Intravenous Infusion for IPF

NCT05016817 — Phase 1, Terminated, 20 participants, The Foundation for Orthopaedics and Regenerative Medicine

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

Registry	NCT05016817
Status	Terminated - Inadequate treatment response observed in preliminary data did not justify enrolling further study participants
Phase	Phase 1
Study type	Interventional; na, single group, masking: none, treatment
Enrollment	20 (Actual)
Sponsor	The Foundation for Orthopaedics and Regenerative Medicine (Other)
Conditions	Idiopathic Pulmonary Fibrosis
Interventions	AlloRx (Biological)
Dates	start 2022-07-03, primary completion 2025-11-30, completion 2025-11-30, first posted 2021-08-23, last updated 2026-10-20
Locations	1 site in Antigua and Barbuda

-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

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+Detailed description

Studies have shown that stem cell treatment is safe for Idiopathic pulmonary fibrosis (IPF) and can improve the prognosis of afflicted patients. Patients with IPF will receive a single intravenous infusion of cultured allogeneic adult umbilical cord derived mesenchymal stem cells. 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.

For patients with more severe disease requiring chemotherapeutic drugs such as methotrexate, an autologous T Cell vaccine will be utilized created from the patient's own T cells obtained by apheresis

+Arms and interventions

Arm	Type	Interventions	Description
Treatment Group	Experimental	Biological: AlloRx	Single intravenous infusion of 100 million cells

AlloRx (Biological): cultured allogeneic adult umbilical cord derived mesenchymal stem cells

+Outcome measures

Primary outcomes

Safety (adverse events) [Four year follow-up]: Clinical monitoring of possible adverse events or complications

Secondary outcomes

Efficacy: Forced vital capacity (FVC) [Four year follow-up]: It will be completed for each follow up point.
Efficacy: Oxygen saturation test [Four year follow-up]: It will be completed for each follow up point.

+Eligibility

Sex: All

Inclusion Criteria:

* Diagnosis of Idiopathic Pulmonary Fibrosis
* 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

+Locations (1)

Facility	City	Country	Status
Medical Surgical Associates Center	St John's	Antigua and Barbuda

+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

+Investigators

Chadwick Prodromos, MD, Principal investigator, The Foundation for Orthopaedics and Regenerative Medicine