ADSCs Therapy in Patients With CTD-ILD
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age20-80
SponsorChina Medical University Hospital
About this trial
Connective tissue disease (CTD), an autoimmune and inflammatory disease, usually accompanied by lung interstitial/alveolar inflammation and fibrosis (so called interstitial lung disease, ILD). The prevalence and mortality rate of CTD-ILD increase in recent several years. Although the use of corticosteroids and strong immunosuppressants can improve ILD in some patients with CTD, progressive lung fibrosis which needs lung transplantation and results in respiratory failure, even with mortality is observed. Currently, stem cell therapy is a breakthrough in the treatment of CTD-ILD, and the effective therapy with stem cells for patients with ILD have been reported.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Adult subjects aged between 20 and 80 years who meet the diagnostic criteria for connective tissue diseases such as dermatomyositis, polymyositis, scleroderma, systemic lupus erythematosus, rheumatoid arthritis, or Sjogren's syndrome.
Subjects with refractory or progressive fibrotic interstitial lung disease: Subjects have been treated with steroids and potent immunosuppressants for more than 24 months with continued deterioration of lung function or lung lesions on CT scan (defined as a forced vital capacity (FVC) decline of more than 10% from baseline, an FVC decline of 5-10% with a diffusing capacity for carbon monoxide (DLCO) decline of more than 15% from baseline, or enlargement of lung lesions on CT scan) ; Or subjects with rapidly progressive interstitial lung disease: treated with high-dose steroids (above 0.8 mg/kg/day) and potent immunosuppressants for more than 3 months with continued deterioration of lung function or lung lesions on CT scan (defined as an FVC decline of more than 5% from baseline, a DLCO decline of more than 10% from baseline, or enlargement of lung lesions on CT scan); subjects with rapidly worsening condition: Onset of pulmonary symptoms within one month, gradual worsening of dyspnea and decreased blood oxygen levels, or enlargement of lung lesions.
Subjects must have a well-established family support system confirmed by interviews with the principal investigator and social worker.
Negative high-sensitivity urine pregnancy test before the trial.
Disqualifiers
Subjects who are unwilling to sign the informed consent form after detailed explanation by the physician.
Patients younger than 20 or older than 80 years who show improvement in lung function or lung lesions on CT scan after 6 months of treatment with steroids and immunosuppressants.
Women who are pregnant or breastfeeding, and women of childbearing age who do not use contraception.
Subjects with abnormal liver function (serum GOT and GPT levels more than twice the upper limit of 40 units, except those caused by inflammatory myopathy) or poor kidney function (serum creatinine levels exceeding 1.4 units).
Trial design
Design model
Single group
Treatments tested in this trial
ADSC01
Biological/VaccineThe initial 3 subjects will receive low-dose AD-MSC (1x10E6 cells/kg) infusion therapy only once; if no adverse events after 4 weeks, the next 4-7 subjects will receive medium-dose AD-MSC (1x10E6 cells/kg) infusion therapy twice; if no adverse events after 4 weeks of the last infusion, the next 8-10 subjects will receive high-dose AD-MSC (1x10E6 cells/kg) infusion therapy three times.
Treatment groups
16 Participants
are divided into 1 treatment groupGroup A: ADSC01Experimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Safety profile (between the first infusion of AD-MSCs and 48 weeks after the last infusion of AD-MSCs)
1. Stable blood pressure: systolic pressure 90-120mmHg and diastolic pressure 60-80mmHg measured after resting for 10 minutes 2. Stable pulse rate: ranges 60-100/minute after resting for 10 minutes 3. Stable respiratory rate: ranges 12-20/minute after resting for 10 minutes 4. Normal body temperature 35.7℃-37.9℃. 5. Resting oxygen saturation≧90% without oxygen use. 6. Absence of AD-MSCs infusion-related serious adverse event.
Time frame
48 weeksSecondary outcomes
1
Efficacy profile (between the first infusion of AD-MSCs and 48 weeks after the last infusion of AD-MSCs)
1. Change of six-minute walking distance(6MWD): Increase of 6MWD≧5% from baseline at week 12, 8% at week 24, 10% at week 48. 2. St. George's Respiratory Questionnaire: Change of score≧5% from baseline at week 12, 10% at week 24, 15% at week 48. 3. Quality of life (SF-36): Increase of score≧5% from baseline at week 12, 8% at week 24, 10% at week 48. 4. Forced vital capacity (FVC): Decrement of FVC\<5% at week 12, increment ≧5% at week 24, increment ≧10% at week 48. 5. Diffusing capacity for carbon monoxide (DLco): Decrement of DLco \<5% at week 12, increment≧5% at week 24, increment≧10% at week 48 6. The extent of ILD (interstitial lung disease) lesion in HRCT: Decrement of ILD extent≧5% at week 24, and decrement of ILD extent≧10% at week 48.
Time frame
week 48.Sponsors and contacts
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Source ClinicalTrials.gov