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

Study Purpose

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

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Interventional
Eligible Ages	N/A and Over
Gender	All

More Inclusion & Exclusion Criteria

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

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT05016817
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.	Phase 1
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	The Foundation for Orthopaedics and Regenerative Medicine
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	Chadwick Prodromos, MD
Principal Investigator Affiliation	The Foundation for Orthopaedics and Regenerative Medicine
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Other
Overall Status	Recruiting
Countries	Antigua and Barbuda, Argentina, Mexico
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Idiopathic Pulmonary Fibrosis

Additional Details

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 & Interventions

Arms

Experimental: Treatment Group

Single intravenous infusion of 100 million cells

Interventions

Biological: - AlloRx

cultured allogeneic adult umbilical cord derived mesenchymal stem cells

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.