Trial document




drksid header

  DRKS00008790

Trial Description

start of 1:1-Block title

Title

Safety and clinical effectiveness of autologous mesenchymal stromal cell infusion as adjunct
treatment in patients with Idiopathic Pulmonary Fibrosis

end of 1:1-Block title
start of 1:1-Block acronym

Trial Acronym

[---]*

end of 1:1-Block acronym
start of 1:1-Block url

URL of the Trial

[---]*

end of 1:1-Block url
start of 1:1-Block public summary

Brief Summary in Lay Language

Idiopathic pulmonary fibrosis (IPF) is a chronic disease characterized by a progressive decline in lung function and associated with a poor prognosis. A number of treatments have been investigated in the past for IPF but these are no longer considered effective treatment options. Many studies suggest the hypothesis that IPF is an inflammatory disorder with following fibrosis of lung tissue. The study motivation came from evidence that mesenchymal stromal cells (MSC) can repair damaged lung tissue, reduce inflammation and prevent fibrosis in the lungs. MSC will be extracted from IPF patients’ bone marrow, cultured and re-infused to the patients. Safety and clinical effectiveness of MSC treatment will be assessed and compared with conventional treatment for IPF.

end of 1:1-Block public summary
start of 1:1-Block scientific synopsis

Brief Summary in Scientific Language

Idiopathic pulmonary fibrosis (IPF) is defined as a specific form of chronic, progressive fibrosing interstitial pneumonia of unknown cause, occurring primarily in older adults, and limited to the lungs. It is characterized by progressive worsening of dyspnea and lung function and is associated with a poor prognosis. A number of treatments have been investigated in the past for IPF, including interferon gamma-1β, bosentan, ambrisentan, and anticoagulants, but these are no longer considered effective treatment options. Many studies are based on the hypothesis that IPF is an inflammatory disorder. Some preclinical studies have shown that MSC can reduce inflammation-induced damage in the lungs, they also can prevent pulmonary fibrosis by decreasing expression of transforming growth factor β1. In this clinical trial patients with IPF will receive infusion of autologous bone marrow derived MSC. Safety and clinical effectiveness of MSC treatment will be assessed and compared with conventional treatment for IPF.

end of 1:1-Block scientific synopsis
start of 1:1-Block organizational data

Organizational Data

  •   DRKS00008790
  •   2015/07/13
  •   [---]*
  •   yes
  •   Approved
  •   EC-01 RRPCPTB, Ethic Committee of the Republican Research and Practical Centre for Pulmonology and TB, Minsk, Belarus
end of 1:1-Block organizational data
start of 1:n-Block secondary IDs

Secondary IDs

  • [---]*
end of 1:n-Block secondary IDs
start of 1:N-Block indications

Health Condition or Problem studied

  •   J84.1 -  Other interstitial pulmonary diseases with fibrosis
end of 1:N-Block indications
start of 1:N-Block interventions

Interventions/Observational Groups

  •   Single infusion of autologous MSC will be given to patients with IPF in addition to conventional therapy. Conventional therapy can include: non-pharmacological (oxygen, if hypoxic; pulmonary rehabilitation); pharmacological (prescribed after specialists discussion in accordance with “An Official ATS/ERS/JRS/ALAT Statement: Idiopathic Pulmonary Fibrosis: Evidence-based Guidelines for Diagnosis and Management” and based on patients’ individual values and preferences); treatment of comorbidities (pulmonary hypertension and gastroesophageal reflux) and symptoms control.
  •   Patients with IPF on conventional therapy. Conventional therapy can include: non-pharmacological (oxygen, if hypoxic; pulmonary rehabilitation); pharmacological (prescribed after specialists discussion in accordance with “An Official ATS/ERS/JRS/ALAT Statement: Idiopathic Pulmonary Fibrosis: Evidence-based Guidelines for Diagnosis and Management” and based on patients’ individual values and preferences); treatment of comorbidities (pulmonary hypertension and gastroesophageal reflux) and symptoms control.
end of 1:N-Block interventions
start of 1:1-Block design

Characteristics

  •   Interventional
  •   [---]*
  •   Randomized controlled trial
  •   Open (masking not used)
  •   [---]*
  •   Active control
  •   Treatment
  •   Parallel
  •   I-II
  •   N/A
end of 1:1-Block design
start of 1:1-Block primary endpoint

Primary Outcome

The primary end points are the following: the adverse events, the changes in vital capacity and DLCO between baseline and month 6, 12.

end of 1:1-Block primary endpoint
start of 1:1-Block secondary endpoint

Secondary Outcome

Chest X-ray and CT scan at baseline, 6 and 12 months, and mortality during 12 months

end of 1:1-Block secondary endpoint
start of 1:n-Block recruitment countries

Countries of Recruitment

  •   Belarus
end of 1:n-Block recruitment countries
start of 1:n-Block recruitment locations

Locations of Recruitment

  • University Medical Center 
end of 1:n-Block recruitment locations
start of 1:1-Block recruitment

Recruitment

  •   Planned
  •   2015/08/31
  •   40
  •   Multicenter trial
  •   National
end of 1:1-Block recruitment
start of 1:1-Block inclusion criteria

Inclusion Criteria

  •   Both, male and female
  •   21   Years
  •   75   Years
end of 1:1-Block inclusion criteria
start of 1:1-Block inclusion criteria add

Additional Inclusion Criteria

Patients 21 through 75 years of age with diagnose of IPF based on diagnostic criteria of “An Official ATS/ERS/JRS/ALAT Statement: Idiopathic Pulmonary Fibrosis: Evidence-based Guidelines for Diagnosis and Management”. The duration of the disease should be more than three months, bilateral predominantly basilar inspiratory crackles should be present. In addition, the following functional abnormalities should be present: dyspnea, vital capacity of no more than 80 percent of the predicted value, single-breath carbon monoxide diffusing capacity (DLCO) less than 80 percent of the predicted value.

end of 1:1-Block inclusion criteria add
start of 1:1-Block exclusion criteria

Exclusion Criteria

Any one of the criteria below makes the patient non-eligible for enrolment into the study:
1. HIV positivity
2. Hepatitis B or C positivity
3. Tuberculosis
4. Autoimmune or systemic diseases
5. Pregnancy
6. liver, renal or other organ/system failure(s)
7. Sepsis
8. Cancer
9. Younger than 21 years and older than 75 years

end of 1:1-Block exclusion criteria
start of 1:n-Block addresses

Addresses

  • start of 1:1-Block address primary-sponsor
    • The Republican Research and Practical Centre for Pulmonology and TB
    • Dr.  Alena  Skrahina 
    • Dolginovski trakt, 157
    • 220053  Minsk
    • Belarus
    end of 1:1-Block address primary-sponsor
    start of 1:1-Block address contact primary-sponsor
    end of 1:1-Block address contact primary-sponsor
  • start of 1:1-Block address scientific-contact
    • The Republican Research and Practical Centre for Pulmonology and TB
    • Dr.  Alena  Skrahina 
    • Dolginovski trakt, 157
    • 220053  Minsk
    • Belarus
    end of 1:1-Block address scientific-contact
    start of 1:1-Block address contact scientific-contact
    end of 1:1-Block address contact scientific-contact
  • start of 1:1-Block address public-contact
    • The Rupublican Research and Practical Centre for Pulmonology and TB
    • Dr.  Alena  Skrahina 
    • Dolginovski trkt, 157
    • 220053  Minsk
    • Belarus
    end of 1:1-Block address public-contact
    start of 1:1-Block address contact public-contact
    end of 1:1-Block address contact public-contact
end of 1:n-Block addresses
start of 1:n-Block material support

Sources of Monetary or Material Support

  • start of 1:1-Block address materialSupport
    • State Committee on Science and Technology of the Republic of Belarus
    • 1 Akademitcheskaya str.
    • 220072  Minsk
    • Belarus
    end of 1:1-Block address materialSupport
    start of 1:1-Block address contact materialSupport
    end of 1:1-Block address contact materialSupport
end of 1:n-Block material support
start of 1:1-Block state

Status

  •   Recruiting planned
  •   [---]*
end of 1:1-Block state
start of 1:n-Block publications

Trial Publications, Results and other Documents

  • [---]*
end of 1:n-Block publications
* This entry means the parameter is not applicable or has not been set.