Study of Autologous Mesenchymal Stem Cells to Treat Idiopathic Pulmonary Fibrosis

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT01919827
• Date of registration: 01/08/2013
• Prospective Registration: No
• Primary sponsor: Clinica Universidad de Navarra, Universidad de Navarra
• Public title: Study of Autologous Mesenchymal Stem Cells to Treat Idiopathic Pulmonary Fibrosis CMM/FPI
• Scientific title: Treatment of Idiopathic Pulmonary Fibrosis With Bone Marrow Derived Mesenchymal Stem Cells
• Date of first enrolment: March 2013
• Target sample size: 17
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT01919827
• Study type: Interventional
• Study design: Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: Phase 1

Countries of recruitment

Spain

Key inclusion & exclusion criteria

INCLUSION CRITERIA:

1. Capacity for signing informing consent and express the willing to fulfill all the
requirements of the study protocol during the study.

2. The patients should be, in the researcher opinion, capable to fulfill all the
requirements of the trial.

3. Male or female patients, 30 to 80 years old, inclusive.

4. Diagnosis of idiopathic pulmonary fibrosis according to the following criteria, based
on the ATS/ERS Guidelines:

1. Definite or probable usual interstitial pneumonia confirmed by surgical lung
biopsy.

2. In the absence of surgical lung biopsy, all the following:

i. High resolution CT (HRCT) showing definite findings for idiopathic pulmonary
fibrosis (FPI): bibasal reticular opacities with minimal ground glass opacities.

ii. Absence of other known causes of FPI including toxicity from drugs, environmental
exposure or connective tissue diseases.

iii. Pulmonary function tests showing ventilatory restrictive pattern and/or impaired
gas exchange (FVC and/or DLCO <90% of predicted)

5. FVC = 50% of predicted value with ratio of FEV1 to FVC = 0.70.

6. DLco (corrected for hemoglobin) = 35% predicted value.

7. Capability of performing a 6 minutes walk test at the time of inclusion.

EXCLUSION CRITERIA:

Any of the following:

1. Current pregnancy or lactation.

2. Findings that are diagnostic of an interstitial pneumonia or restrictive respiratory
disease condition other than UIP.

3. Obstructive pulmonary disease defined by FEV1/FVC < 0,7 or significant emphysema on
HRCT.

4. Evidence of sustained improvement in FPI defined by improvement of respiratory
function tests before inclusion, observed in >=2 test over the year prior to
inclusion.

5. Active or recent respiratory infection (less than 60 days before inclusion) or history
of frequent exacerbations of IPF from an infectious cause (more than 2/year over the
last 2 years)

6. Hospitalization in the 60 days prior to inclusion due to acute exacerbation of IPF.

7. Chronic cardiac failure (functional class NYHA III/IV) or left ventricular ejection
fraction < 25%.

8. Chronically receiving corticosteroid more than 10 mg of prednisone or equivalent,
immunosuppressors or antifibrotic agents, including pirfenidone, D-penicillamine,
colchicine, ciclosporin A, TNF-alpha antagonists, imatinib, IFN-gamma, azathioprine,
cyclophosphamide, within the 30 days prior to inclusion.

9. The patient requires hemodialysis, peritoneal dialysis or hemofiltration.

10. History of malignancy, with the exception of skin squamous or basocellular carcinoma
or cervix in situ carcinoma treated successfully.

11. History of ethanol abuse within the year prior to inclusion

12. The patient is participating in a clinical trial which includes other drugs or
research products within the 28 days prior to baseline assessment.

13. Comorbidities limiting life expectancy to less than 12 months from the baseline
assessment.

14. Medical or psychiatric condition serious or active which might interfere with the
treatment of study, assessment or protocol fulfillment.

15. Positive test for HBsAg, HCV antibody, syphilis screening essays, or HIV antibody at
screening.



Age minimum: 30 Years
Age maximum: 80 Years
Gender: All

Health Condition(s) or Problem(s) studied

Idiopathic Pulmonary Fibrosis

Intervention(s)

Biological: Endobronchial infusion of adult mesenchymal stem cells

Biological: Autologous mesenchymal stem cells derived from bone marrow

Primary Outcome(s)

Number of participants with adverse side effects. [Time Frame: Up to 12 months]

Secondary Outcome(s)

Efficacy of the infusion of mesenchymal stem cells in stopping the fall in pulmonary function in patients with mild to moderate IPF [Time Frame: Up to 12 months]

Secondary ID(s)

CMM/FPI

Source(s) of Monetary Support

Please refer to primary and secondary sponsors