Asthma Clinical Trial
Official title:
Safety of Cultured Allogeneic Adult Umbilical Cord Derived Mesenchymal Stem Cell Intravenous Infusion for the Treatment of Pulmonary Diseases
| Verified date | August 2021 |
| Source | The Foundation for Orthopaedics and Regenerative Medicine |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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 Pulmonary Diseases
| Status | Recruiting |
| Enrollment | 20 |
| Est. completion date | December 2025 |
| Est. primary completion date | December 2025 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | N/A and older |
| Eligibility | 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 |
| Country | Name | City | State |
|---|---|---|---|
| Antigua and Barbuda | Medical Surgical Associates Center | St. John's |
| Lead Sponsor | Collaborator |
|---|---|
| The Foundation for Orthopaedics and Regenerative Medicine |
Antigua and Barbuda,
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. — View Citation
Cruz FF, Borg ZD, Goodwin M, Sokocevic D, Wagner D, McKenna DH, Rocco PR, Weiss DJ. Freshly thawed and continuously cultured human bone marrow-derived mesenchymal stromal cells comparably ameliorate allergic airways inflammation in immunocompetent mice. Stem Cells Transl Med. 2015 Jun;4(6):615-24. doi: 10.5966/sctm.2014-0268. Epub 2015 Apr 29. — View Citation
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. — View Citation
Trzil JE, Masseau I, Webb TL, Chang CH, Dodam JR, Liu H, Quimby JM, Dow SW, Reinero CR. Intravenous adipose-derived mesenchymal stem cell therapy for the treatment of feline asthma: a pilot study. J Feline Med Surg. 2016 Dec;18(12):981-990. Epub 2015 Sep 17. — View Citation
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Safety (adverse events) | Clinical monitoring of possible adverse events or complications | Four year follow-up | |
| Secondary | Efficacy: Forced vital capacity (FVC) | It will be completed for each follow up point. | Four year follow-up | |
| Secondary | Efficacy: Pulmonary function test | It will be completed for each follow up point. | Four year follow-up |
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