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Pulmonary EmphysemaPhase 1/2NCT01849159

Clinical Study of the Efficacy and Safety of the Application of Allogeneic Mesenchymal (Stromal) Cells of Bone Marrow, Cultured Under the Hypoxia in the Treatment of Patients With Severe Pulmonary Emphysema

A Phase 1/2 study testing Mesenchymal stem cells and Reference therapy: 400 mL of 0.9% NaCl solution in people with Pulmonary Emphysema, run by Federal Research Clinical Center of Federal Medical & Biological Agency, Russia at 1 site in Russia.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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Trial summary

Actively developing stem cells (SCs) transplantation techniques cause natural interest to the problem of regeneration in the lungs. Numerous experimental studies proved the benefits of different types of SCs in experimental models of pulmonary emphysema (PE). G. Zhen et al. Read more about this study

Who is it for?
Ages 35 to 75 years
Conditions the study is for
Pulmonary Emphysema
What is being tested?
Mesenchymal stem cells and Reference therapy: 400 mL of 0.9% NaCl solution
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
0 participants
Where
1 siteRussia
Study dates
Mar 2014to Jun 2017
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 35 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • HRCT-confirmed diagnosis of lung emphysema by two independent radiologists
  • post-bronchodilator FEV1/FVC ratio < 0.7
  • post-bronchodilator FEV1 % predicted value ≥ 20% and < 50%
  • age 35 and 75 years of, of either sex, and of any race
  • current or ex-smoker, with a cigarette smoking history ≥ 10 pack-years

Who cannot join

  • • asthma or other clinically relevant lung disease other than COPD (e.g. restrictive lung diseases, sarcoidosis, tuberculosis, idiopathic pulmonary fibrosis, or lung cancer)
  • α1-Antitrypsin deficiency
  • Presence of bullae (more than 10 cm in the diameter)
  • active infection within 4 weeks of screening
  • significant exacerbation of COPD or has required mechanical ventilation within 4 weeks of screening
  • clinically relevant uncontrolled medical condition not associated with COPD
Show all 10Show fewer
  • documented history of uncontrolled heart failure
  • pulmonary hypertension due to left heart condition
  • Subject has evidence of active malignancy, or prior history of active malignancy
  • Subject has a life expectancy of < 6 months

Trial locations and contacts

1 site in 1 country.

Russia1 site

  • Federal Research Clinical Center of Federal Medical and Biological Agency of Russia

    Moscow, Moscow Oblast, 115682

Other trials in Russia

About this study

Actively developing stem cells (SCs) transplantation techniques cause natural interest to the problem of regeneration in the lungs. Numerous experimental studies proved the benefits of different types of SCs in experimental models of pulmonary emphysema (PE).

  1. Zhen et al. have shown that the transplantation of mesenchymal stem cells (MSCs) to rats with papain-induced emphysema leads to their migration into the lungs, differentiation into type 2 alveolocytes, and inhibition of apoptosis and prevention PE.
  2. Schweitzer et al. have proved the activity of inflammation in the airways, alveolocytes and endothelial cells apoptosis decreased after adipose SCs intravenous administration to mice with emphysema caused by chronic exposure to tobacco smoke or VEGF receptors blockade. The study of E.P. Ingenito et al. found that endobronchial installed MSCs engraft into the alveolar wall and peribronchial interstitium and release integrins, extracellular matrix components (collagen IV, laminin and fibrillin), platelet-derived growth factor receptor and transforming growth factor β2.
Read more

Our study also found reliable deterrent effect of allogeneic bone marrow MSCs on the development of elastase-induced emphysema in rats at different terms of transplantation.

After the success of pilot studies have started clinical trials. Currently, the website http://www. ClinicalTrials.gov reported three studies evaluating the efficacy and safety of MSC transplantation in patients with COPD and emphysema. Two of them have already been completed and the results of the first pilot project published.

Authors on the example of 4 patients showed a complete absence of adverse effects, improved quality of life and stability of functional parameters at 12 months after starting treatment One of the problems of MSC transplantation in patients with respiratory failure is an accelerated apoptosis of transplanted cells under the influence of proinflammatory cytokines and oxidative stress. Since it is proved that preconditioning MSCs under hypoxia increases their survival in hypoxic conditions, increases the expression of growth factors and antiinflammatory cytokines, we suppose that MSCs grown in hypoxic medium may have a significant positive effect on the disease.

Being tested
Mesenchymal stem cells, Reference therapy: 400 mL of 0.9% NaCl solution
Keywords
Mesenchymal stem cells, Hypoxia, Emphysema
Medical subject headings
Pulmonary Emphysema, Hypoxia, Emphysema

What participants receive

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

  • Mesenchymal stem cellsBiological

    Intravenous infusion of MSC suspension, pre-conditioned under 1% oxygen, in the amount of 200 mln. cells per 400 mL of sodium chloride physiological solution

  • Reference therapy: 400 mL of 0.9% NaCl solutionOther

Study groups in NCT01849159
Study groupRoleWhat they receive
MSC groupActive comparatorIntravenous infusion of MSC suspension, pre-conditioned under 1% oxygen, in the amount of 200 mln. cells per 400 mL of sodium chloride physiological solution. Infusions will be performed every 2 months for 1 year
Receives: Biological: Mesenchymal stem cells
Control GroupPlacebo comparator400 mL of 0.9% NaCl solution. Infusions will be performed every 2 months for 1 year
Receives: Other: Reference therapy: 400 mL of 0.9% NaCl solution

What is being measured

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

  1. Safety compared with placebo

    Mortality (Baseline and 2 years after procedure) Adverse effects and reactions to the treatment(Baseline and 2 years after procedure).

    Vital signs (pulse rate, systolic and diastolic arterial blood pressure) (Baseline and 2 years after procedure)

    Measured: 1 year

Secondary outcomes (9)

  1. Change from baseline in the lung tissue density measured by CT-densitometry at6, 12, 24 months

    Measured: 2 years

  2. DLCO change from baseline at 6, 12, 24 months

    Measured: 2 years

  3. Change from baseline in the functional parameters (FEV1, TLC, RV, FEV1/FVC) at 6,12,18,24 months

    Measured: 2 years

  4. Dynamics of the physical capacity (by the 6-min test results)

    Measured: 2 years

  5. Dynamics of the blood gas composition (PaO2, PaCO2)

    Measured: 2 years

  6. Dynamics of serum level IL-6, TNF-α, Leptin

    Measured: 2 years

  7. Quality of life indices by the questionnaire (SF-36)

    Measured: 2 years

  8. Number and frequency of exacerbations

    Measured: 2 years

  9. Body mass index

    Measured: 2 years

Timeline

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

  1. First posted8 May 2013 (estimated)
  2. Study startMar 2014
  3. Primary completionDec 2016 (estimated)
  4. Study completionJun 2017 (estimated)

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 1/2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01849159
Sponsor's protocol ID
MSC-HYP-01
Other IDs
FMBA-FRCC-MSC-01
Status last verified
Jan 2018
First submitted
24 Apr 2013
Last updated
9 Jan 2018
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing Mesenchymal stem cells and Reference therapy: 400 mL of 0.9% NaCl solution in people with Pulmonary Emphysema, 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 5 inclusion and 10 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: withdrawn, 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 was withdrawn before enrolling participants, so there are no results.

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 compared with placebo (time frame: 1 year). 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 NCT01849159.

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.

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