Human Mesenchymal Stem Cells Infusion in Patients With Cystic Fibrosis (HAPI)
A Phase I, Randomized and Placebo-controlled Trial to Evaluate the Safety, Tolerability, and Potential Efficacy of Allogeneic Human MesenchymAl Stem Cells Infusion in Patients With Cystic Fibrosis – HAPI
Doctors at the University of Miami are seeking participants to trial a cell therapy treatment for cystic fibrosis. Mesenchymal stem cells (MSCs), drawn from healthy donors, will be a single infusion of (MSCs) at one of 4 doses or a placebo, with the goal of assessing the safest and most helpful dose.
For 30 days after the infusion, the patient must report any adverse reactions. Then for 6 to 12 months after, their overall pulmonary function and symptoms, as well as their overall health, will be followed. Approximately 9 visits to the treatment center are expected.
- Be 20 to 45 years of age
- Have a diagnosis of cystic fibrosis
- Not have received an organ transplant and not be actively listed to receive any organ EXCEPT for a lung transplant
THE STUDY INVOLVES:
- Prescreening tests to confirm eligibility and safety of the patient to participate.
- Mesenchymal stem cells will be peripherally (not a central line IV) infused
- After observation, the patient will be discharged and keep in contact to report any adverse reactions.
- Follow up visits will be required, with a total of 9 visits estimated, including screening.
LOCATIONS AND CONTACTS:
The study site is at the University of Miami. Map.
Joshua M Hare, MD | [email protected] | 305-243-7444
Matthias A Salathe, MD | [email protected] | 305-243-6388
Interdisciplinary Stem Cell Institute (ISCI) at the University of Miami
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