AzTrials
AzTrials

Idiopathic Pulmonary FibrosisPhase 1CMM/FPINCT01919827

Study of Autologous Mesenchymal Stem Cells to Treat Idiopathic Pulmonary Fibrosis

A Phase 1 study testing Endobronchial infusion of adult mesenchymal stem cells and Autologous mesenchymal stem cells derived from bone marrow in people with Idiopathic Pulmonary Fibrosis, run by Clinica Universidad de Navarra, Universidad de Navarra at 2 sites in Spain.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

Clinical Trial Phase I, open, multicentric, non randomized, study with escalating doses, to evaluate the safety and feasibility of treatment with mesenchymal stem cells in patients with diagnosis of idiopathic pulmonary fibrosis. Read more about this study

Who is it for?
Ages 30 to 80 years
Conditions the study is for
Idiopathic Pulmonary Fibrosis
What is being tested?
Endobronchial infusion of adult mesenchymal stem cells and Autologous mesenchymal stem cells derived from bone marrow
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
17 participants
Where
2 sitesSpain
Study dates
Mar 2013to 1 May 2018
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 30 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Capacity for signing informing consent and express the willing to fulfill all the requirements of the study protocol during the study.
  • The patients should be, in the researcher opinion, capable to fulfill all the requirements of the trial.
  • Male or female patients, 30 to 80 years old, inclusive.
  • Diagnosis of idiopathic pulmonary fibrosis according to the following criteria, based on the ATS/ERS Guidelines:
  • Definite or probable usual interstitial pneumonia confirmed by surgical lung biopsy.
  • In the absence of surgical lung biopsy, all the following:
Show all 12Show fewer
  • High resolution CT (HRCT) showing definite findings for idiopathic pulmonary fibrosis (FPI): bibasal reticular opacities with minimal ground glass opacities.
  • Absence of other known causes of FPI including toxicity from drugs, environmental exposure or connective tissue diseases.
  • Pulmonary function tests showing ventilatory restrictive pattern and/or impaired gas exchange (FVC and/or DLCO <90% of predicted)
  • FVC ≥ 50% of predicted value with ratio of FEV1 to FVC ≥ 0.70.
  • DLco (corrected for hemoglobin) ≥ 35% predicted value.
  • Capability of performing a 6 minutes walk test at the time of inclusion.

Who cannot join

  • Any of the following:
  • Current pregnancy or lactation.
  • Findings that are diagnostic of an interstitial pneumonia or restrictive respiratory disease condition other than UIP.
  • Obstructive pulmonary disease defined by FEV1/FVC < 0,7 or significant emphysema on HRCT.
  • 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.
  • 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)
Show all 16Show fewer
  • Hospitalization in the 60 days prior to inclusion due to acute exacerbation of IPF.
  • Chronic cardiac failure (functional class NYHA III/IV) or left ventricular ejection fraction < 25%.
  • 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.
  • The patient requires hemodialysis, peritoneal dialysis or hemofiltration.
  • History of malignancy, with the exception of skin squamous or basocellular carcinoma or cervix in situ carcinoma treated successfully.
  • History of ethanol abuse within the year prior to inclusion
  • The patient is participating in a clinical trial which includes other drugs or research products within the 28 days prior to baseline assessment.
  • Comorbidities limiting life expectancy to less than 12 months from the baseline assessment.
  • Medical or psychiatric condition serious or active which might interfere with the treatment of study, assessment or protocol fulfillment.
  • Positive test for HBsAg, HCV antibody, syphilis screening essays, or HIV antibody at screening.

Trial locations and contacts

2 sites in 1 country.

Spain2 sites

  • Servicio de Neumología, Clínica Universidad de Navarra

    Pamplona, Navarre, 31008 Pamplona

  • Servicio de Neumología. Hospital Universitario de Salamanaca

    Salamanca

Other trials in Spain

About this study

Official title: Treatment of Idiopathic Pulmonary Fibrosis With Bone Marrow Derived Mesenchymal Stem Cells

Clinical Trial Phase I, open, multicentric, non randomized, study with escalating doses, to evaluate the safety and feasibility of treatment with mesenchymal stem cells in patients with diagnosis of idiopathic pulmonary fibrosis.

Primary endpoint: The aim is to evaluate the safety and feasibility of the endobronchial administration of mesenchymal autolog stem cells derived from bone marrow (BM-MSC)in patients with mild-to-moderate idiopathic pulmonary fibrosis.

Secondary endpoint:Assess the possible effect of the infusion of BM-MSC in stopping the fall of pulmonary function in patients with mild-to-moderate idiopathic pulmonary fibrosis.

Being tested
Endobronchial infusion of adult mesenchymal stem cells, Autologous mesenchymal stem cells derived from bone marrow
Keywords
Idiopathic pulmonary fibrosis, Stem cells, Mesenchymal stem cells
Medical subject headings
Idiopathic Pulmonary Fibrosis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Endobronchial infusion of adult mesenchymal stem cellsBiological

  • Autologous mesenchymal stem cells derived from bone marrowBiological

Study groups in NCT01919827
Study groupRoleWhat they receive
MSC endobronchial infusionExperimentalNot described
Receives: Biological: Endobronchial infusion of adult mesenchymal stem cells; Biological: Autologous mesenchymal stem cells derived from bone marrow

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of participants with adverse side effects.

    Number of participants with adverse side effects, and according to the level of severity:

    1. Low level: Increase in cough, fever or skin reactions
    2. Medium level: Infections not requiring hospital admission, mild alterations of renal or liver function
    3. High level: Death or major side effects requiring hospitalization:
    4. Worsening dyspnea with >=10% reduction in forced vital capacity, reduction in arterial pressure oxygen >= 10 mmHg and radiology progression between 3 months separated visits.
    5. Need for hospitalization due to respiratory failure requiring mechanical ventilation, worsening in gases exchange or lung infection.
    6. Carcinogenesis at 12 months after the endobronchial infusion of mesenchymal stem cells.

    Measured: Up to 12 months

Secondary outcomes (1)

  1. Efficacy of the infusion of mesenchymal stem cells in stopping the fall in pulmonary function in patients with mild to moderate IPF

    Measures of efficacy:

    1. Fall in forced vital capacity as a continuous variable
    2. Progression of the disease defined by: Death, need for transplantation or deterioration in pulmonary function defined by fall in forced vital capacity (FVC) > 10% or in lung diffusion capacity (DLCO) > 15%.

    Measured: Up to 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Aug 2013 (estimated)
  2. Study startMar 2013
  3. Primary completion1 May 2018
  4. Study completion1 May 2018

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
17 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01919827
Sponsor's protocol ID
CMM/FPI
Acronym
CMM/FPI
Status last verified
May 2018
First submitted
1 Aug 2013
Last updated
3 May 2018
Results posted
No
Data monitoring committee
Yes

Publications

  • Campo A, Gonzalez-Ruiz JM, Andreu E, Alcaide AB, Ocon MM, De-Torres J, Pueyo J, Cordovilla R, Villaron E, Sanchez-Guijo F, Barrueco M, Nunez-Cordoba J, Prosper F, Zulueta JJ. Endobronchial autologous bone marrow-mesenchymal stromal cells in idiopathic pulmonary fibrosis: a phase I trial. ERJ Open Res. 2021 Jun 28;7(2):00773-2020. doi: 10.1183/23120541.00773-2020. eCollection 2021 Apr.

    PubMed 34195252

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Endobronchial infusion of adult mesenchymal stem cells and Autologous mesenchymal stem cells derived from bone marrow in people with Idiopathic Pulmonary Fibrosis, run by Clinica Universidad de Navarra, Universidad de Navarra at 2 sites in Spain.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 12 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 3 May 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of participants with adverse side effects. (time frame: Up to 12 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01919827, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 May 2018.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in