Idiopathic Interstitial PneumoniaPhase 1/2NCT02594839
Safety and Efficacy of Allogeneic Mesenchymal Stem Cells in Patients With Rapidly Progressive Interstitial Lung Disease
A Phase 1/2 study testing Bone marrow mesenchymal stem cells in people with Idiopathic Interstitial Pneumonia and Interstitial Lung Disease, run by Federal Research Clinical Center of Federal Medical & Biological Agency, Russia at 1 site in Russia.
Trial summary
The study evaluates the safety and the efficacy of the addition of intravenous transplantation of donor bone marrow mesenchymal stem cells in patients with idiopathic interstitial pneumonia or connective tissue disease associated with interstitial lung disease, which have actively progressing disease with rapid loss… Read more about this study
- Who is it for?
- Ages 20 to 80 years
- Conditions the study is for
- Idiopathic Interstitial Pneumonia, Interstitial Lung Disease, Idiopathic Pulmonary Fibrosis
- What is being tested?
- Bone marrow mesenchymal stem cells
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 1 siteRussia
- Study dates
- Feb 2013to Jan 2018
- Phase
- Phase 1/2
- 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 20 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male and female patients 20-80 years old
- Diagnosis of idiopathic interstitial pneumonia or secondary to connective tissue diseases interstitial lung disease, based on:
- Clinical symptoms > 12 months duration,
- Histologically diagnosed or diagnostic chest HRCT features of interstitial pneumonia
- Forced Vital Capacity (FVC) ≥ 40% predicted and Diffusing Lung Capacity (DLCO) ≥20%
- Loss more than 10% of FVC (L) and DLCO during the last 12 months
- Signed informed consent.
Who cannot join
- Diagnosis of an interstitial lung disease other than idiopathic interstitial pneumonia or connective tissue disease associated with interstitial lung disease (sarcoidosis, pulmonary alveolar proteinosis, lymphangioleiomyomatosis, pulmonary amyloidosis, exposure-related lung disease etc)
- Obstructive lung disease: FEV1/FVC < 0.70
- Clinically significant medical condition, in the opinion of the investigator, may compromise the results of the study
- Evidence of active infection within 4 week prior to enrollment
- History of malignancy < 5 years prior to enrollment
- Unable to cooperate with any study procedures
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- Pregnant or breast-feeding
- Treatment with antiinflammatory or antifibrotic drugs including oral steroids, cytostatic drugs, pirfenidone, D penicillamine, colchicine, tumor necrosis factor α blockers, imatinib, interferon γ, monoclonal antibodies < 6 months prior to randomization.
- Active listing for transplant of any organ.
- Known history of alcohol abuse within 1 year prior to enrollment
- Participation in another clinical trial
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase I-II Study to Evaluate Safety and Efficacy of Allogeneic Bone-Marrow Mesenchymal Stem Cells in Patients With Rapidly Progressive Interstitial Lung Disease
The study evaluates the safety and the efficacy of the addition of intravenous transplantation of donor bone marrow mesenchymal stem cells in patients with idiopathic interstitial pneumonia or connective tissue disease associated with interstitial lung disease, which have actively progressing disease with rapid loss of pulmonary function on the background of routine treatment.
Read the detailed description
Despite significant progress in the treatment of interstitial lung disease, achieved thanks to new drugs, such as pirfenidone and nintedanib, there are many patients for whom these drugs are not available or poorly tolerated. In addition significant evidence of their effectiveness and safety is valid only for idiopathic pulmonary fibrosis. The transplantation of allogeneic stem cells is a promising direction in the modern medicine with the proven safety for different diseases. But the effectiveness of this therapy is still under research. We believe that in most severe cases of a rapidly progressive interstitial lung disease the transplantation of mesenchymal stem cells may be an effective technology due to their immunomodulatory properties.
- Conditions
- Idiopathic Interstitial Pneumonia, Interstitial Lung Disease, Idiopathic Pulmonary Fibrosis
- Being tested
- Bone marrow mesenchymal stem cells, Placebo
- Keywords
- interstitial lung disease, idiopathic interstitial pneumonia, idiopathic pulmonary fibrosis, stem cells
- Medical subject headings
- Idiopathic Interstitial Pneumonias, Lung Diseases, Interstitial, Idiopathic Pulmonary Fibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bone marrow mesenchymal stem cellsDrug
Bone marrow will be harvested in healthy donors followed by separation and cultivation of MSCs. Before infusion cells will be suspended in 400 mL saline
PlaceboDrug
intravenous infusion of 400 mL saline
| Study group | Role | What they receive |
|---|---|---|
| MSCs | Experimental | 2 intravenous infusions of suspension of 200 000 000 MSCs each at interval of 7 days. Infusions will be repeated every 3 months for 1 year. Receives: Drug: Bone marrow mesenchymal stem cells |
| placebo | Placebo comparator | 2 intravenous infusions of 400 mL saline each at interval of 7 days. Infusions will be repeated every 3 months for 1 year. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety: Number of serious adverse events
registration of adverse events related to infusion and 12 months follow-up
Measured: 12 months
Secondary outcomes (3)
DLCO changes from baseline
Assessment of the diffusing lung capacity at 3, 6, 9, 12 months of treatment
Measured: 12 months
FVC changes from baseline
Assessment of spirometry at 3, 6, 9, 12 months of treatment
Measured: 12 months
exercise capacity changes
Assessment of 6MWD at 3, 6, 9, 12 months of treatment
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Nov 2015 (estimated)
- Study startFeb 2013
- Primary completionJan 2018
- Study completionJan 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Idiopathic Interstitial PneumoniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Federal Research Clinical Center of Federal Medical & Biological Agency, Russia
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02594839
- Sponsor's protocol ID
- ILD-01
- Status last verified
- Jan 2018
- First submitted
- 1 Nov 2015
- Last updated
- 9 Jan 2018
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 9 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I-II Study to Evaluate Safety and Efficacy of Allogeneic Bone-Marrow Mesenchymal Stem Cells in Patients With Rapidly Progressive Interstitial Lung Disease
- ClinicalTrials.gov ID
- NCT02594839
- Acronym / sponsor ID
- ILD-01
- Conditions
- Idiopathic Interstitial Pneumonia, Interstitial Lung Disease, Idiopathic Pulmonary Fibrosis
- Keywords
- interstitial lung disease, idiopathic interstitial pneumonia, idiopathic pulmonary fibrosis, stem cells
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Federal Research Clinical Center of Federal Medical & Biological Agency, RussiaOther government
- Study start
- Feb 2013
- Primary completion
- Jan 2018 (actual)
- Study completion
- Jan 2018 (actual)
- First posted
- 3 Nov 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The study evaluates the safety and the efficacy of the addition of intravenous transplantation of donor bone marrow mesenchymal stem cells in patients with idiopathic interstitial pneumonia or connective tissue disease associated with interstitial lung disease, which have actively progressing disease with rapid loss of pulmonary function on the background of routine treatment.
Detailed description
Despite significant progress in the treatment of interstitial lung disease, achieved thanks to new drugs, such as pirfenidone and nintedanib, there are many patients for whom these drugs are not available or poorly tolerated. In addition significant evidence of their effectiveness and safety is valid only for idiopathic pulmonary fibrosis. The transplantation of allogeneic stem cells is a promising direction in the modern medicine with the proven safety for different diseases. But the effectiveness of this therapy is still under research. We believe that in most severe cases of a rapidly progressive interstitial lung disease the transplantation of mesenchymal stem cells may be an effective technology due to their immunomodulatory properties.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| MSCs | Experimental | Drug: Bone marrow mesenchymal stem cells2 intravenous infusions of suspension of 200 000 000 MSCs each at interval of 7 days. Infusions will be repeated every 3 months for 1 year. |
| placebo | Placebo comparator | Drug: Placebo2 intravenous infusions of 400 mL saline each at interval of 7 days. Infusions will be repeated every 3 months for 1 year. |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Male and female patients 20-80 years old
- Diagnosis of idiopathic interstitial pneumonia or secondary to connective tissue diseases interstitial lung disease, based on:
- Forced Vital Capacity (FVC) ≥ 40% predicted and Diffusing Lung Capacity (DLCO) ≥20%
- Loss more than 10% of FVC (L) and DLCO during the last 12 months
- Signed informed consent.
Key exclusion criteria (11 listed)
- Diagnosis of an interstitial lung disease other than idiopathic interstitial pneumonia or connective tissue disease associated with interstitial lung disease (sarcoidosis, pulmonary alveolar proteinosis, lymphangioleiomyomatosis, pulmonary amyloidosis, exposure-related lung disease etc)
- Obstructive lung disease: FEV1/FVC < 0.70
- Clinically significant medical condition, in the opinion of the investigator, may compromise the results of the study
- Evidence of active infection within 4 week prior to enrollment
- History of malignancy < 5 years prior to enrollment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Bone marrow mesenchymal stem cellsBone marrow will be harvested in healthy donors followed by separation and cultivation of MSCs. Before infusion cells will be suspended in 400 mL saline | Drug | MSCs |
| Placebointravenous infusion of 400 mL saline | Drug | placebo |
Primary outcome
Safety: Number of serious adverse events
Time frame: 12 months
registration of adverse events related to infusion and 12 months follow-up
3 secondary outcomes
DLCO changes from baseline
Time frame: 12 months
FVC changes from baseline
Time frame: 12 months
exercise capacity changes
Time frame: 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jan 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Bone marrow mesenchymal stem cells in people with Idiopathic Interstitial Pneumonia and Interstitial Lung Disease, run by Federal Research Clinical Center of Federal Medical & Biological Agency, Russia at 1 site in Russia.
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 7 inclusion and 11 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 9 Jan 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Russia. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined 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.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Safety: Number of serious adverse events (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 9 Jan 2018.