Idiopathic Pulmonary Fibrosis Clinical Trial
Official title:
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).
Despite intense research efforts and clinical trials, there is still no effective treatment
that can prolong the survival of patients with IPF. Conventional therapeutic approach
includes combination of corticosteroids, anti-oxidants, immunodepressants and immune
modulatory anti-fibrotic agents to be discontinued 20 days before screening. The only, so
far, therapeutic approach that has been proven effective in terms of prolonging patient's
survival is lung transplantation. Nonetheless, not all the patients with IPF are eligible
for lung transplantation; there is a significant proportion of these patients that finally
succumb while waiting in a lung transplantation list. Therefore, there is critical need for
more effective and reliable therapeutic modalities5. Adult Stem Cells (ASCs) seem to
represent one of these. Therefore, it is conceivable to assume that adult-stem cells can be
easily and safely be applied as a novel therapeutic agent in chronic and fatal lung
diseases, including chronic obstructive pulmonary disease (COPD) and IPF.
Therefore, there is an urgent need to provide a safe, effective and affordable treatment
option for IPF patients. New diagnostic, prognostic and therapeutic strategies need to be
developed to reduce the burden of IPF. Given the present lack of appropriate treatment
adjunctive in the therapy of IPF, adipose derived stromal vascular fraction provides new
opportunities for development of the same.
MSCs are having anti-fibrotic activity and hence may be excellent source to tackle pulmonary
fibrosis and hence could be explored for their therapeutic potential for treating Idiopathic
pulmonary fibrosis. MSC's also display membrane-bound and insoluble secreted molecules
involved with cell attachment to neighbouring cells and to the extra cellular matrix.18 This
cell surface configuration may enable mesenchymal stem cells to home from bloodstream to
mesenchymal tissue.14
As limited clinical information is available about use of SVF and MSC in the IPF patients
hence this Open Label, Prospective, Randomized multi center comparative study has been
undertaken to explore the tolerability & effectiveness of SVF in one treatment arm and MSC
in second treatment arm in IPF patients.
Adipose derived stromal vascular fraction and Mesenchymal Stem Cells has been found in
preclinical studies to be safe and effective
Status | Recruiting |
Enrollment | 60 |
Est. completion date | |
Est. primary completion date | August 2015 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 30 Years to 70 Years |
Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
India | Kasiak Research Pvt Ltd | Thane | Maharashtra |
Lead Sponsor | Collaborator |
---|---|
Kasiak Research Pvt. Ltd. |
India,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Safety | The Incidence of treatment emergent Adverse Event (AE) in the study. | 9 Month | Yes |
Secondary | Efficacy | Change in predicted FVC% at EOS Change in predicted DLCO% at EOS Change in the 6MWT at EOS Changes in the disease extent and severity as reflected by HRCT (64 SLICE) at EOS from randomisation. | 9 Month | No |
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