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Cystic Fibrosis - Healing Genes
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Cystic Fibrosis

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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


DESCRIPTION:

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.


PATIENT MUST:

  • 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:

  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.

LOCATIONS AND CONTACTS:

The study site is at the University of Miami. Map.

Contacts:

Joshua M Hare, MD | [email protected] | 305-243-7444

Matthias A Salathe, MD | [email protected] | 305-243-6388

 

SPONSOR INFORMATION:

Interdisciplinary Stem Cell Institute (ISCI) at the University of Miami

 

Or go online:

https://clinicaltrials.gov/ct2/show/NCT03058068

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