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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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19 February 2015 |
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Main ID: |
NCT02135380 |
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Date of registration:
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08/05/2014 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Evaluate Safety and Efficacy of Intravenous Autologous ADMSc for Treatment of Idiopathic Pulmonary Fibrosis
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Scientific title:
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A Prospective, Multicentric, Phase I/II, Open Label, Randomized, Interventional Study to Evaluate the Safety and Efficacy of Intravenous Autologous Adipose Derived Adult Stem Cells for Treatment of Idiopathic Pulmonary Fibrosis (IPF). |
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Date of first enrolment:
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August 2014 |
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Target sample size:
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60 |
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Recruitment status: |
Recruiting |
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URL:
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http://clinicaltrials.gov/show/NCT02135380 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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Phase:
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Phase 1/Phase 2
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Countries of recruitment
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India
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Contacts
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Name:
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Dr. Pankaj A Thakur, PhD |
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Address:
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Telephone:
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+91-(022)-411 73463 |
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Email:
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pankaj.thakur@kasiakresearch.com |
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Affiliation:
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Name:
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Dr.Sujeet K Rajan, M.B.B.S.M.D. |
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Address:
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Telephone:
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Email:
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Affiliation:
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Bhatia General Hospital |
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Name:
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Dr. Ashok A Mahashur, M.B.B.S.M.D. |
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Address:
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Telephone:
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Email:
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Affiliation:
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P.D. Hinduja National Hospital and Medical Research Centre |
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Name:
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Dr. Pratibha S Singhal, M.B.B.S.M.D. |
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Address:
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Telephone:
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Email:
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Affiliation:
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Bombay Hospital and Medical Research Council |
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Name:
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Dr.Pankaj A Thakur, PhD |
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Address:
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Telephone:
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+91-(022)-411 73463 |
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Email:
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pankaj.thakur@kasiakresearch.com |
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Affiliation:
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Name:
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Dr. Kartik B Shah, M.B.B.S.M.D. |
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Address:
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Telephone:
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Email:
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Affiliation:
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Cumballa Hill Hospital And Heart Institute |
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Key inclusion & exclusion criteria
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Inclusion:
1. Subjects aged 30 to 70 years.
2. Diagnosed subjects of IPF (HRCT scan suggestive or consistent with a probable
diagnosis of usual interstitial pneumonia)
3. Diagnosis of IPF = three months before enrolment in the study. In addition, the
following functional abnormalities must be present:
- Dyspnoea score of at least 2, on a scale of 0 (minimum) to 4 (maximum) on
Modified Medical Research Council (MRC) scale
- Forced Vital Capacity (FVC) of no more than 50 to 80 percent of the predicted
value
- Diffusing Lung Capacity for Carbon Monoxide (DLCO) 30 to 80 percent of the
predicted value
4. The subject should be stable and able to walk = 50 meters in the 6MWT. If
supplemental oxygen is needed, this should not exceed 4 litres per min at rest.
5. Subjects with adequate subcutaneous fat available for liposuction as assessed by the
Plastic Surgeon before liposuction procedure.
6. Subjects who have been found medically fit by the chest physician for the use
sedation and/ local anesthetic before the Liposuction procedure, INR value of below
2 before liposuction procedure
7. Subject who are not currently on or have discontinued treatment with
immune-suppressants and/or corticosteroids within at least 20 days prior to
screening.
8. Non-pregnant, non-lactating females of age =18 years, and woman of childbearing
potential
9. Men who are sexually active and agree to routinely use barrier method from screening
and throughout the course of the study or who have undergone sterilization.
Exclusion:
1. Newly diagnosed subjects of IPF who have not received any treatment for the disease
or are drug naïve subjects of IPF.
2. Subjects with a diagnosis of severe Pulmonary hypertension and a Mean Pulmonary
Arterial Pressure (mPAP) of >50 mm of Hg by 2D-Echo.
3. Forced Vital Capacity (FVC) less than 50 percent of the predicted value
4. Diffusing Lung Capacity for Carbon Monoxide (DLCO) less than 30 percent of the
predicted value
5. History of interstitial pulmonary fibrosis due to collagen vascular disease,
connective tissue disorders and autoimmune disease
6. Subjects with any type of cancer or other serious concomitant diseases including
tuberculosis, granulomatous lung disease (e.g. Sarcoidosis) or any condition in the
investigator's opinion that will make the ineligible for the study
7. History of clinically significant environmental exposure, ingestion of a drug or
cases of pulmonary fibrosis due to hypersensitivity pneumonitis
8. History of unstable or deteriorating cardiac or pulmonary disease other than IPF
within the 6 months prior to enrolment.
9. Subjects who are pregnant, breast-feeding or have childbearing potential and have had
a positive pregnancy test prior to receiving the therapy.
10. Subject who has received treatment with an investigational drug within prior 3 months
or is otherwise participating in another clinical study
11. Subject who has undergone surgery within 30 days prior to screening or has planned
major surgery.
12. Subject/Subject's LAR/impartial witness not willing or able to give written informed
consent to participate in the study
Age minimum:
30 Years
Age maximum:
70 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Idiopathic Pulmonary Fibrosis
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Intervention(s)
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Biological: Autologous Adipose Derived MSCs (ADMSCs)
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Biological: Autologous Stromal Vascular Fraction (SVF)
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Other: Control
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Primary Outcome(s)
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Safety
[Time Frame: 9 Month]
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Secondary Outcome(s)
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Efficacy
[Time Frame: 9 Month]
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Secondary ID(s)
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KRPL/IPF/11-12/002
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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