An Early Phase 1 interventional study of GD-iExo-001 and normal saline in Atopic Dermatitis, sponsored by Peking Union Medical College Hospital. Recruiting at 1 site in China. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2023-08-01.
Sponsored by Peking Union Medical College Hospital · Early Phase 1, Interventional, and Treatment
Evaluate the safety, tolerability, and preliminary efficacy of GD-iExo-001 in the treatment of atopic dermatitis
Atopic dermatitis (AD) is a chronic inflammatory skin disease that is characterised by intense itching and recurrent eczematous lesions. Although it most often starts in infancy and affects two of ten children, it is also highly prevalent in adults. It is the leading non-fatal health burden attributable to skin diseases, inflicts a substantial psychosocial burden on patients and their relatives, and increases the risk of food allergy, asthma, allergic rhinitis, other immune-mediated inflammatory diseases, and mental health disorders. Originally regarded as a childhood disorder mediated by an imbalance towards a T-helper-2 response and exaggerated IgE responses to allergens, it is now recognised as a lifelong disposition with variable clinical manifestations and expressivity, in which defects of the epidermal barrier are central. Present prevention and treatment focus on restoration of epidermal barrier function, which is best achieved through the use of emollients. Topical corticosteroids are still the first-line therapy for acute flares, but they are also used proactively along with topical calcineurin inhibitors to maintain remission.
Exosomes are nano-sized biovesicles released into surrounding body fluids upon fusion of multivesicular bodies and the plasma membrane. They were shown to carry cell-specific cargos of proteins, lipids, and genetic materials, and can be selectively taken up by neighboring or distant cells far from their release, reprogramming the recipient cells upon their bioactive compounds. Therefore, the regulated formation of exosomes, specific makeup of their cargo, cell-targeting specificity are of immense biological interest considering extremely high potential of exosomes as non-invasive diagnostic biomarkers, as well as therapeutic nanocarriers.
Induced pluripotent stem cells (iPSCs) are pluripotent stem cells generated from adult cells by reprogramming. iPSCs have the same properties as embryonic stem cells, and therefore self-renew and can differentiate into all cell types of the body except for cells in extra-embryonic tissues such as the placenta. iPSC-derived exosomes contain TGF- β、 BDNF etc., which can inhibit cell apoptosis, inhibit inflammatory response, promote angiogenesis, inhibit fibrosis, and enhance tissue repair potential, with a wide range of potential applications. iPSC-derived exosomes have emerged as an important paracrine factor for iPSCs to repair injured cells through the delivery of bioactive components.
The purpose of this trial is to evaluate the safety, tolerability, and preliminary efficacy of iPSC-derived exosomes in the treatment of atopic dermatitis.
1,419 studies on the registry are indexed under Dermatitis, Atopic; 258 are open to participants now.
This study's planned enrollment of 20 is below the median of 83 across 1,125 interventional studies indexed under Dermatitis, Atopic.
Browse Dermatitis, Atopic studies →Peking Union Medical College Hospital is the lead sponsor of 1,115 studies on the registry; 463 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Group1 (low-dose group), 8 papatients are treated with 10 μg/mL GD-iExo-001. Group2 (high-dose group), 8 papatients are treated with 50 μg/mL GD-iExo-001. One drop (about 50 μL) of GD-iExo-001 was given to the affected skin area of 2-4 cm2 for 14 consecutive days, twice per day.
Drug: GD-iExo-001
Group1 (low-dose group), 2 papatients are treated with normal saline. Group2 (high-dose group), 2 papatients are treated with normal saline. One drop (about 50 μL) of normal saline was given to the affected skin area of 2-4 cm2 for 14 consecutive days, twice per day.
Other: normal saline
One drop (about 50 μL) of GD-iExo-001 was given to the affected skin area of 2-4 cm2 for 14 consecutive days, twice per day.
One drop (about 50 μL) of normal saline was given to the affected skin area of 2-4 cm2 for 14 consecutive days, twice per day.
adverse events as assessed by CTCAE
all potentially treated subjects to assess the safety
Time frame: 42 days from post-administration
The proportion of subjects whose IGA score improved by 2 points or more compared with the baseline score.
Time frame: Screening, after the first administration 8 day, 15 days, 21 days, 42 days
The proportion of subjects with an IGA score of 0-1 and an improvement of 2 or more over the baseline score
Time frame: Screening, after the first administration 8 day, 15 days, 21 days, 42 days
The proportion of subjects whose EASI score improved by more than 50% compared with the baseline period
Time frame: Screening, after the first administration 8 day, 15 days, 21 days, 42 days
The proportion of subjects whose EASI score improved by more than 75% compared with the baseline period
Time frame: Screening, after the first administration 8 day, 15 days, 21 days, 42 days
The proportion of subjects whose EASI score improved by more than 90% compared with the baseline period
Time frame: Screening, after the first administration 8 day, 15 days, 21 days, 42 days
Change in the score of the NRS
Time frame: Screening, after the first administration 8 day, 15 days, 21 days, 42 days
Change in the score of the DLQI
Time frame: Screening, after the first administration 8 day, 15 days, 21 days, 42 days
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Peking Union Medical College Hospital