Cystic Fibrosis - Healing Genes

Cystic Fibrosis

Share This Post

Share on facebook
Share on linkedin
Share on twitter
Share on email

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

Phase 1


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


  1. Prescreening tests to confirm eligibility and safety of the patient to participate.
  2. Mesenchymal stem cells will be peripherally (not a central line IV) infused
  3. After observation, the patient will be discharged and keep in contact to report any adverse reactions.
  4. Follow up visits will be required, with a total of 9 visits estimated, including screening.


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


Or go online:

Subscribe To Our Newsletter

Get updates and learn from the best

More To Explore

Vanquishing the Virus: 160+ COVID-19 Drug and Vaccine Candidates in Development

While President Trump continues to promote antimalarial drugs such as hydroxychloroquine sulfate and azithromycin to treat COVID-19—“What do you have to lose?” he exclaimed during the April 4 Coronavirus Task Force Briefing—the global community of drug discovery researchers and biopharmas is developing a much broader