NCT07923838Active, not recruitingPhase 1/2
Clinical Safety and Efficacy of Umbilical Cord Mesenchymal Stromal Cells-derived Exosomes in Patients With Parkinson's Disease
Source: ClinicalTrials.gov · Last updated 6 Nov 2026
Brief summary (registry, in English)
The goal of this clinical trial is to learn if intranasal umbilical cord mesenchymal stromal cell-derived exosomes (UCMSC-Exo) are safe and can help treat early Parkinson's disease in adults aged 50-75. It will also learn about the safety and tolerability of UCMSC-Exo. This is a single-center, open-label, dose-escalation study using a 3+3 design; there is no placebo and no blinding. The main questions it aims to answer are: 1. What local and systemic adverse events and serious adverse events occur with intranasal UCMSC-Exo? 2. Does intranasal UCMSC-Exo improve motor and non-motor symptoms, biomarkers, and imaging measures in Parkinson's disease? 3. Researchers will compare low-, medium-, and high-dose UCMSC-Exo groups sequentially to assess safety and preliminary efficacy. Participants will: 1. Receive UCMSC-Exo by nasal spray twice weekly (Monday/Thursday) for 12 weeks (24 administrations) at their assigned dose. 2. Continue their usual dopaminergic medication during the study. 3. Visit the clinic for safety assessments at weeks 4, 12, 16, and 48, and for efficacy assessments at weeks 12, 16, 24, 36, and 48. 4. Undergo blood sampling, symptom questionnaires, and PET-MR imaging at scheduled time points. 5. Be followed for a total of 48 weeks, including the 12-week treatment period and 36 weeks after treatment.
- Status (registry)
- Active, not recruiting
- Phase (registry)
- Phase 1/2
- Study type
- Interventional
- Enrollment
- 9 (actual)
- First submitted
- 2 Nov 2026
- Start date
- 28 Oct 2024
- Primary completion date
- 30 Jun 2027
- Lead sponsor
- Shanghai Jiao Tong University School of Medicine
- Diseases
- Parkinson disease
- NCT number
- NCT07923838
What you commit to
- Study type: Interventional · Phase 1/2
- Participants enrolled: 9
- From 28 Oct 2024 to the primary completion date, 30 Jun 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study design.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Previous treatment with allogeneic mesenchymal stromal cells or their exosomes.
Other illness
- Severe allergic constitution.
- Severe or poorly controlled comorbidities, including but not limited to cardiovascular, cerebrovascular, hepatic, renal, endocrine, hematologic, dermatologic, and other systemic diseases.
- Other neurological diseases, including but not limited to stroke, traumatic brain injury, parkinsonism, or cognitive impairment.
- 8、Severe psychiatric symptoms or hallucinations.
- 9、History of malignancy or markedly abnormal tumor markers.
- 10、Severe systemic infection within the past 3 months.
- 11、MRI contraindications, including but not limited to cardiac pacemaker, claustrophobia, or implanted metal devices.
- 12、Positive infectious disease screening for HIV, HBV, HCV, or Treponema pallidum (syphilis).
- 13、Drug abuse or addiction within the past 10 years.
- 14、Participation in another clinical trial within the past 6 months.
- 15、Current pregnancy or breastfeeding, or pregnancy/breastfeeding within the past 6 months.
- 16、Any condition that the investigator considers unsuitable for enrollment.
Lab values
- Any of the following laboratory abnormalities: neutrophil count <1.0×10\^9/L; platelet count <100×10\^9/L; serum albumin <30 g/L; serum creatinine > upper limit of normal; ALT/AST >2× upper limit of normal.
Other
- Severe depression.
Who the study is looking for
- Confirmed sporadic idiopathic Parkinson's disease according to the UK Brain Bank clinical diagnostic criteria.
- On dopaminergic therapy for ≥60 days.
- Hyposmia, defined as SS-16 score <9.
- Hoehn and Yahr stage ≤2.5.
- Age 50-75 years.
- MMSE score ≥25.
- Good general health with no clinically significant abnormalities on laboratory tests.
- No contraindications to MRI.
- No autoimmune immunosuppressive disease and no current use of any immunosuppressive drug.
- Able to independently and voluntarily provide dated informed consent.
- Willing to comply with study procedures and able to adhere to the full study and intervention period.
Age in the registry: 50 years to 75 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Ruijin Hospital Shanghai Jiao Tong Universtiy Coordinator of this site? Confirm its status | Shanghai | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.