Idopathic pulmonary fibrosis interstitial pneumonia
Conditions
Interventions
After getting consent, assess pre-trial examination, and register the cases who are qualified for this clinical trial.
ADR-001 is given on day 1, and observe safety until day 8 as inpatients.
The tre
stem cells
Sponsors
Miyahara Nobuaki
ROHTO Pharmaceutical Co., Ltd
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) no less than 40 years old. 2) informed consent of this study 3) diagnosis of IPF 4) FVC no less than 50% of predicted value 5) %DLCO 30~37% 6) PO2 no less than 55mmHg 7) Patiens with treatment history of anti-fibrotic treatment but who discontined because of its side effects or getting no enough efficacy.
Exclusion criteria
Exclusion criteria: 1)Obstructive pulmonary dysfunction:FEV1/FVC<0.7 2)Patiens who need exygen therapy15 hours a day or more. 3)History of acute exacerbation within 6 weeks of getting consent or examination 2 4)Habing infection which need to be treated at getting consent or at examination 2 5)HB, HCV, HIV, or HTLV-1 antibody positive at examination 1 6)History of organ, bone marrow or other cell transplantation, or cell therapy 7)Possibiity of getting lung transplantation during clinical trial period 8)Mortality less than 2.5 years due to other diseases than IPF 9)Treatment with anti-fibrotic drugs (nintedanib, pirfenidone), tacrolimus, cyclophosphamide, or mycophenolate mofetil wihin 8 weeks of getting consent 10)Treatment with other Investigational new drugs within 4 weeks of getting consent 11)Treatment with more than 10 mg of predonizolone within 8 weeks of getting consent. Dose change of predonizolone within 8 weeks of getting consent even if the dose is less than 10 mg/day 12)Severe liver, renal, heart diseases, severe organ failure, or severe complications as follows: T-bil 1.5 times more than value more than normal limit. Cr value more than 2mg Congestive Heart failure (NYHA:Class III-IV) except for the patients who have dyspnea due to IPF. Active conorary artery diseases Uncontrolled hypertention Arrhythmia: Grade 2 or more in TCAE ver 5.0 13)Getiing treatment of malignancy, history of malignancy treatment within 5 years, except for cervical intraepithelial carcinoma and gastric mucosal cancer following comlete recection, and basal cell carcinoma and squamous cell carcinoma of the skin following appropriate treatment 14)During pregnancy or lactating. Fertile female patients who do not prevent pregnancy during a month from the point of time of examination 1. 15) Male fertile patients who do not use a condom during clinical trial period 16)Abuce of alchohol or substance 17)Difficulty of getting consent due to mental illness 18)Allergy for penicillin, aminoglycosidee antibiotics, or dimethylsulfoxide 19)patients who are judged as unqualified cases by the doctors involved in he clinical trial
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safty: MTD, DLT, adversed effects. | — |
Secondary
| Measure | Time frame |
|---|---|
| Efficacy (symptoms, PaO2, Chest CT findings, &MD, respiratory function test, Japanese version of SGRQ-1) | — |
Contacts
Public ContactAkihiko Taniguchi
Department of Allergy and Respiratory Medicine, Okayama University Hospital
Outcome results
None listed