- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05016817
Safety of Cultured Allogeneic Adult Umbilical Cord Derived Mesenchymal Stem Cell Intravenous Infusion for IPF
Safety of Cultured Allogeneic Adult Umbilical Cord Derived Mesenchymal Stem Cell Intravenous Infusion for the Treatment of Idiopathic Pulmonary Fibrosis
Study Overview
Status
Conditions
Intervention / Treatment
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
Study Type
Enrollment (Anticipated)
Phase
- Phase 1
Contacts and Locations
Study Locations
-
-
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St. John's, Antigua and Barbuda
- Recruiting
- Medical Surgical Associates Center
-
-
-
-
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Buenos Aires, Argentina
- Recruiting
- Center for Investigation in Tissue Engineering and Cellular Therapy
-
-
-
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N.L
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San Pedro Garza García, N.L, Mexico
- Recruiting
- Medyca Bosques
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Treatment Group
Single intravenous infusion of 100 million cells
|
cultured allogeneic adult umbilical cord derived mesenchymal stem cells
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Safety (adverse events)
Time Frame: Four year follow-up
|
Clinical monitoring of possible adverse events or complications
|
Four year follow-up
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Efficacy: Forced vital capacity (FVC)
Time Frame: Four year follow-up
|
It will be completed for each follow up point.
|
Four year follow-up
|
Efficacy: Oxygen saturation test
Time Frame: Four year follow-up
|
It will be completed for each follow up point.
|
Four year follow-up
|
Collaborators and Investigators
Publications and helpful links
General 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.
- 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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- SC-10-ATG-13-08
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Idiopathic Pulmonary Fibrosis
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St. Antonius HospitalZonMw: The Netherlands Organisation for Health Research and Development; Boeringer...RecruitingPulmonary Fibrosis Idiopathic FamilialNetherlands
-
Wake Forest University Health SciencesMayo Clinic; The University of Texas Health Science Center at San AntonioCompletedIdiopathic Pulmonary Fibrosis (IPF)United States
-
Sheba Medical CenterUnknownIDIOPATHIC PULMONARY FIBROSISIsrael
-
Theravance BiopharmaTerminatedIdiopathic Pulmonary Fibrosis (IPF)United Kingdom
-
University of California, San FranciscoCompletedIdiopathic Pulmonary Fibrosis (IPF)United States
-
BiogenCompletedIdiopathic Pulmonary Fibrosis (IPF)United States
-
Liminal BioSciences Ltd.CompletedIdiopathic Pulmonary Fibrosis (IPF)Canada
-
Bristol-Myers SquibbCompletedIdiopathic Pulmonary Fibrosis (IPF)United States
-
Angion Biomedica CorpNot yet recruitingIdiopathic Pulmonary Fibrosis (IPF)
-
Xfibra, Inc.Not yet recruitingIdiopathic Pulmonary Fibrosis (IPF)
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