Using stem cell-derived exosomes to treat atopic dermatitis

Exploratory Clinical Study on Induced Pluripotent Stem Cell Derived Exosomes (GD-iExo-001) for the Treatment of Atopic Dermatitis

This study is testing a new treatment made from stem cells to see if it can help adults with atopic dermatitis feel better.

Quick facts

• Phase: Early Phase 1
• Study type: Interventional
• Enrollment: 20 (estimated)
• Ages: 18 Years to 70 Years
• Sex: All
• Sponsor: Peking Union Medical College Hospital (Academic / other)
• Drugs / interventions: immunotherapy
• Locations: 1 site (Beijing, Beijing)
• Trial ID: NCT05969717 on ClinicalTrials.gov

What this trial studies

This clinical trial evaluates the safety, tolerability, and preliminary efficacy of GD-iExo-001, an exosome treatment derived from induced pluripotent stem cells, for patients with atopic dermatitis. The study aims to address the chronic inflammatory nature of atopic dermatitis, which significantly impacts patients' quality of life. Participants will receive either the GD-iExo-001 treatment or normal saline as a control. The trial will include adults aged 18 to 70 who meet specific health criteria and have been diagnosed with atopic dermatitis.

Who should consider this trial

Good fit: Ideal candidates for this study are adults aged 18 to 70 with a diagnosis of atopic dermatitis and specific severity criteria.

Not a fit: Patients with active infections or other significant health issues may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a novel therapeutic option for patients suffering from atopic dermatitis, potentially improving their skin condition and overall quality of life.

How similar studies have performed: While the use of exosomes in treatment is a novel approach, similar studies have shown promise in other conditions, indicating potential for success in this area.

Eligibility criteria

Inclusion Criteria:

* Age 18 to 70 years, body mass index (BMI) between 18 and 35 kg/m2 (including boundary values);
* Overall good health except AD;
* Participants diagnosed with atopic dermatitis (AD) as defined by the Hanifin and Rajka criteria;
* Investigator overall assessment (IGA) score of 2 to 3;
* Participants with a history of subacute or chronic AD symptoms for at least 6 months;
* Participants with body surface area (BSA) of AD involvement of ≤5% at screening and baseline;
* Participants and their partners agreed to use effective contraception throughout the study period (from screening to 3 months after completion of treatment);
* Participants understood and voluntarily signed the informed consent form.

Exclusion Criteria:

* There are obvious active systemic or local infections, including but not limited to the infection of AD secondary infection, local bacterial infection in target lesion, local viral infection in target lesion, and local fungal infection in target lesion. Note: After the infection resolves, the patients can be re-screened;
* Presence of any of the following conditions: HB surface antigen (HBsAg) positive and / or HB e antigen (HBeAg) positive, HB e antibody (HBeAb) and / or hepatitis B core antibody (HBcAb) positive and hepatitis B virus deoxyribonucleic acid (HBV-DNA) copy number\> 2000 IU / mL; limited hepatitis C virus (HCV) antibody positive and peripheral blood hepatitis C virus (HCV) RNA positive; positive human immunodeficiency virus (HIV) antibody; positive for syphilis (TPA) test;
* Inoculate live or attenuated vaccine within 4 weeks before screening or during the study period;
* Received allergen specific immunotherapy within 6 months before screening;
* Use of topical drugs known or may affect AD within 2 weeks before screening (including but not limited to topical glucocorticoids; calcineurin inhibitors: such as tacrolimus, pirolimus, etc.);
* Use of immunosuppressants and Janus kinase inhibitors within 4 weeks before screening;
* Use of any biological agent (such as IL-4 receptor inhibitors, IL-13 inhibitors) for 12 weeks before screening or 5 half-lives (whichever is longer);
* Received systemic or local Chinese medicine treatment (including Chinese medicine immersion treatment) within 2 weeks before screening;
* Treated with UV and photochemistry within 4 weeks prior to screening;
* Required systemic treatment of antiviral, antiparasitic, antigenic, or antifungals within 4 weeks prior to screening;
* With significant abnormal findings or laboratory values and clinical significance, such as white blood cell count \<3.0e9 / L; neutrophils \<1 LLN; hemoglobin \<90g / L; platelet \<100e9 / L; serum creatinine\> 1.5 ULN, ALT or AST 2 ULN; QTcF\> 450 msec (male) or QTcF\> 470 msec (female);
* Other combined (or co-occurrence) skin diseases that may affect the study evaluation, such as acne, psoriasis, lupus erythematosus, etc.; or large tattoos, birthmarks, skin scars, skin ulcers and other conditions that may affect the judgment of the investigator;
* Except for AD, any history of clinical major disease or clinically significant circulatory system abnormality, endocrine system abnormality, neurological or hematological disorders, immune system disease, psychiatric illness and metabolic instability; clinical significance is defined as the risk of the safety of the subject or aggravating the disease / disease during the study;
* Patients with a history of severe skin allergy and / or allergy to any ingredients of the product;
* History of cancer in the past 5 years (except for surgically removed squamous cell carcinoma, basal cell carcinoma, or skin carcinoma in situ);
* Any major surgery within 8 weeks before screening; or subjects expected to undergo surgery during the trial or within 4 weeks after the end of the trial; or 400 mL nonphysiological blood loss (including trauma, blood collection, blood donation within 12 weeks before screening);
* Pregnant women, lactating women, or women who plan to become pregnant during the study (fertile women must have a urine pregnancy test with negative results);
* Subjects who are currently participating in other clinical trials or who have participated in other clinical trials within 90 days;
* The investigator judged any other condition not suitable to participate in this study.

Where this trial is running

Beijing, Beijing

• Chinese Academy of Medical Science & Peking Union Medical College Hospital — Beijing, Beijing, China (Recruiting)

Study contacts

• Principal investigator: Hongzhong Jin, MD — Peking Union Medical College Hospital
• Study coordinator: Ju Qiao, PhD

Conditions Atopic Dermatitis