Parkinson Disease (PD)Phase 1/2UC-MSC-Exos PDNCT07923838

Clinical Safety and Efficacy of Umbilical Cord Mesenchymal Stromal Cells-derived Exosomes in Patients With Parkinson's Disease

A Phase 1/2 study testing Umbilical cord mesenchymal stromal cell-derived exosomes (UCMSC-Exo) in people with Parkinson Disease (PD), run by Shanghai Jiao Tong University School of Medicine at 1 site in China.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record

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Trial summary

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. Read more about this study

Who is it for?: Ages 50 to 75 years
Conditions the study is for: Parkinson Disease (PD)
What is being tested?: Umbilical cord mesenchymal stromal cell-derived exosomes (UCMSC-Exo)
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 9 participants
Where: 1 siteChina
Study dates: 28 Oct 2024to 30 Jun 2027
Phase: Phase 1/2
Are there results?: Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 50 to 75 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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.

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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.

Who cannot join

Severe allergic constitution.
Previous treatment with allogeneic mesenchymal stromal cells or their exosomes.
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.
Severe or poorly controlled comorbidities, including but not limited to cardiovascular, cerebrovascular, hepatic, renal, endocrine, hematologic, dermatologic, and other systemic diseases.
Severe depression.
Other neurological diseases, including but not limited to stroke, traumatic brain injury, parkinsonism, or cognitive impairment.

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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.

Trial locations and contacts

1 site in 1 country.

China1 site

Ruijin Hospital Shanghai Jiao Tong Universtiy
Shanghai, Shanghai Municipality, 200025

Other trials in China

About this study

The main questions it aims to answer are:

What local and systemic adverse events and serious adverse events occur with intranasal UCMSC-Exo?
Does intranasal UCMSC-Exo improve motor and non-motor symptoms, biomarkers, and imaging measures in Parkinson's disease?
Researchers will compare low-, medium-, and high-dose UCMSC-Exo groups sequentially to assess safety and preliminary efficacy.

Participants will:

Receive UCMSC-Exo by nasal spray twice weekly (Monday/Thursday) for 12 weeks (24 administrations) at their assigned dose.
Continue their usual dopaminergic medication during the study.
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.
Undergo blood sampling, symptom questionnaires, and PET-MR imaging at scheduled time points.
Be followed for a total of 48 weeks, including the 12-week treatment period and 36 weeks after treatment.

Conditions: Parkinson Disease (PD)
Being tested: Umbilical cord mesenchymal stromal cell-derived exosomes (UCMSC-Exo)
Medical subject headings: Parkinson Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Umbilical cord mesenchymal stromal cell-derived exosomes (UCMSC-Exo)Biological
UCMSC-Exo is an open-label product of exosomes from umbilical cord mesenchymal stromal cells (UCMSCs) in saline. It is a transparent liquid given by intranasal spray, not intravenously, and contains no living cells. Each dose is 0.4 mL total (200 µL/nostril; 2 sprays/nostril at ~100 µL/spray), twice weekly (Mon/Thu) for 12 weeks (24 doses), with usual dopaminergic therapy continued. A 3+3 design tests low (5×10^8 particles/mL), medium (1×10^9 particles/mL), and high (2×10^9 particles/mL) concentrations; volume is identical, concentration differs. Escalation proceeds only with no DLT; 1 DLT expands a cohort to 6; >1 DLT stops escalation. Store at -80°C; use within 2 hours after thawing. Key distinctions: acellular UCMSC-derived exosomes, intranasal route, fixed twice-weekly 12-week regimen, sequential dose escalation, no placebo.

Study groups in NCT07923838
Study group	Role	What they receive
Low-dose intranasal UCMSC-Exo	Experimental	Open-label umbilical cord mesenchymal stromal cell-derived exosomes (UCMSC-Exo) given by intranasal spray at 5×10^8 particles/mL. Each administration is 0.4 mL total (200 µL per nostril), twice weekly (Monday/Thursday) for 12 weeks (24 doses). Participants continue their usual dopaminergic therapy. In the 3+3 design, the cohort expands to 6 participants if 1 dose-limiting toxicity (DLT) occurs; escalation stops if >1 DLT occurs. Receives: Biological: Umbilical cord mesenchymal stromal cell-derived exosomes (UCMSC-Exo)
Medium-dose intranasal UCMSC-Exo	Experimental	Open-label UCMSC-Exo given by intranasal spray at 1×10^9 particles/mL. Each administration is 0.4 mL total (200 µL per nostril), twice weekly (Monday/Thursday) for 12 weeks (24 doses). Participants continue their usual dopaminergic therapy. This cohort starts only if no DLT occurs in the low-dose cohort. In the 3+3 design, the cohort expands to 6 participants if 1 DLT occurs; escalation stops if >1 DLT occurs. Receives: Biological: Umbilical cord mesenchymal stromal cell-derived exosomes (UCMSC-Exo)
High-dose intranasal UCMSC-Exo	Experimental	Open-label UCMSC-Exo given by intranasal spray at 2×10^9 particles/mL. Each administration is 0.4 mL total (200 µL per nostril), twice weekly (Monday/Thursday) for 12 weeks (24 doses). Participants continue their usual dopaminergic therapy. This cohort starts only if no DLT occurs in the medium-dose cohort. In the 3+3 design, the cohort expands to 6 participants if 1 DLT occurs; escalation stops if >1 DLT occurs. Receives: Biological: Umbilical cord mesenchymal stromal cell-derived exosomes (UCMSC-Exo)

What is being measured

The primary outcome is the main question the study is designed to answer.

Incidence, severity, and relatedness of local and systemic adverse events and serious adverse events after intranasal UCMSC-Exo in early Parkinson's disease
Primary safety outcome: incidence, severity, and relationship to study intervention of local and systemic adverse events (AEs) and serious adverse events (SAEs) after intranasal UCMSC-Exo. Local AEs include pain, itching, sneezing, bleeding, allergy, and hyposmia. Systemic AEs include fever, systemic allergic reactions (rash, redness), abnormal inflammatory markers (WBC, CRP), hepatic impairment (ALT/AST >2× ULN), renal impairment (serum creatinine > ULN), anemia (Hb <120 g/L in men; <110 g/L in women), and abnormal tumor markers. SAEs include severe allergic reactions (edema, asthma). Safety is assessed by physical examination, vital signs, laboratory tests (CBC/CRP, liver and renal function, electrolytes, fasting glucose, IgE, EKG), and AE/SAE questionnaires at Weeks 4, 12, 16, and 48; tumor markers, cardiac markers, DIC, and lipids are assessed at Week 48.
Measured: From first dose through Week 48; safety assessments at Weeks 4, 12, 16, and 48

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

28 Oct 202430 Jun 2027

First posted6 Nov 2026
Study start28 Oct 2024
Primary completion30 Jun 2027 (estimated)
Study completion30 Jun 2027 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Parkinson Disease (PD)Studies of the same condition, open and under way.
More trials run by Shanghai Jiao Tong University School of MedicineThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1/2
Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Single group
Masking: None (open label)
Enrolment: 9 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT07923838
Sponsor's protocol ID: 2024-422
Acronym: UC-MSC-Exos PD
Status last verified: Oct 2026
First submitted: 2 Nov 2026
Last updated: 6 Nov 2026
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No: No IPD sharing is planned. The protocol does not include a data-sharing plan for individual participant data. Data will be stored securely with password protection and used only for this study; only aggregate/summary results will be published, and the trial will be registered publicly.

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 6 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Clinical Safety and Efficacy of Umbilical Cord Mesenchymal Stromal Cells-derived Exosomes in Patients With Parkinson's Disease
ClinicalTrials.gov ID: NCT07923838
Acronym / sponsor ID: UC-MSC-Exos PD / 2024-422
Conditions: Parkinson Disease (PD)
Phase: Phase 1/2
Study type: Interventional
Recruitment status: Active, not recruiting
Enrolment: 9 participants (actual)
Lead sponsor: Shanghai Jiao Tong University School of MedicineUniversity, hospital or other
Study start: 28 Oct 2024 (actual)
Primary completion: 30 Jun 2027 (estimated)
Study completion: 30 Jun 2027 (estimated)
First posted: 6 Nov 2026 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

The main questions it aims to answer are:

What local and systemic adverse events and serious adverse events occur with intranasal UCMSC-Exo?
Does intranasal UCMSC-Exo improve motor and non-motor symptoms, biomarkers, and imaging measures in Parkinson's disease?
Researchers will compare low-, medium-, and high-dose UCMSC-Exo groups sequentially to assess safety and preliminary efficacy.

Participants will:

Receive UCMSC-Exo by nasal spray twice weekly (Monday/Thursday) for 12 weeks (24 administrations) at their assigned dose.
Continue their usual dopaminergic medication during the study.
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.
Undergo blood sampling, symptom questionnaires, and PET-MR imaging at scheduled time points.
Be followed for a total of 48 weeks, including the 12-week treatment period and 36 weeks after treatment.

Study design

Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Single group
Masking: None (open label)
Number of arms: 3

Arm	Type	Receives
Low-dose intranasal UCMSC-Exo	Experimental	Biological: Umbilical cord mesenchymal stromal cell-derived exosomes (UCMSC-Exo)Open-label umbilical cord mesenchymal stromal cell-derived exosomes (UCMSC-Exo) given by intranasal spray at 5×10^8 particles/mL. Each administration is 0.4 mL total (200 µL per nostril), twice weekly (Monday/Thursday) for 12 weeks (24 doses). Participants continue their usual dopaminergic therapy. In the 3+3 design, the cohort expands to 6 participants if 1 dose-limiting toxicity (DLT) occurs; escalation stops if >1 DLT occurs.
Medium-dose intranasal UCMSC-Exo	Experimental	Biological: Umbilical cord mesenchymal stromal cell-derived exosomes (UCMSC-Exo)Open-label UCMSC-Exo given by intranasal spray at 1×10^9 particles/mL. Each administration is 0.4 mL total (200 µL per nostril), twice weekly (Monday/Thursday) for 12 weeks (24 doses). Participants continue their usual dopaminergic therapy. This cohort starts only if no DLT occurs in the low-dose cohort. In the 3+3 design, the cohort expands to 6 participants if 1 DLT occurs; escalation stops if >1 DLT occurs.
High-dose intranasal UCMSC-Exo	Experimental	Biological: Umbilical cord mesenchymal stromal cell-derived exosomes (UCMSC-Exo)Open-label UCMSC-Exo given by intranasal spray at 2×10^9 particles/mL. Each administration is 0.4 mL total (200 µL per nostril), twice weekly (Monday/Thursday) for 12 weeks (24 doses). Participants continue their usual dopaminergic therapy. This cohort starts only if no DLT occurs in the medium-dose cohort. In the 3+3 design, the cohort expands to 6 participants if 1 DLT occurs; escalation stops if >1 DLT occurs.

Who may qualify

Ages: 50 to 75 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (11 listed)

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.

Key exclusion criteria (15 listed)

Severe allergic constitution.
Previous treatment with allogeneic mesenchymal stromal cells or their exosomes.
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.
Severe or poorly controlled comorbidities, including but not limited to cardiovascular, cerebrovascular, hepatic, renal, endocrine, hematologic, dermatologic, and other systemic diseases.
Severe depression.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Umbilical cord mesenchymal stromal cell-derived exosomes (UCMSC-Exo)UCMSC-Exo is an open-label product of exosomes from umbilical cord mesenchymal stromal cells (UCMSCs) in saline. It is a transparent liquid given by intranasal spray, not intravenously, and contains no living cells. Each dose is 0.4 mL total (200 µL/nostril; 2 sprays/nostril at ~100 µL/spray), twice weekly (Mon/Thu) for 12 weeks (24 doses), with usual dopaminergic therapy continued. A 3+3 design tests low (5×10^8 particles/mL), medium (1×10^9 particles/mL), and high (2×10^9 particles/mL) concentrations; volume is identical, concentration differs. Escalation proceeds only with no DLT; 1 DLT expands a cohort to 6; >1 DLT stops escalation. Store at -80°C; use within 2 hours after thawing. Key distinctions: acellular UCMSC-derived exosomes, intranasal route, fixed twice-weekly 12-week regimen, sequential dose escalation, no placebo.	Biological	High-dose intranasal UCMSC-Exo, Low-dose intranasal UCMSC-Exo, Medium-dose intranasal UCMSC-Exo

Primary outcome

Incidence, severity, and relatedness of local and systemic adverse events and serious adverse events after intranasal UCMSC-Exo in early Parkinson's disease
Time frame: From first dose through Week 48; safety assessments at Weeks 4, 12, 16, and 48
Primary safety outcome: incidence, severity, and relationship to study intervention of local and systemic adverse events (AEs) and serious adverse events (SAEs) after intranasal UCMSC-Exo. Local AEs include pain, itching, sneezing, bleeding, allergy, and hyposmia. Systemic AEs include fever, systemic allergic reactions (rash, redness), abnormal inflammatory markers (WBC, CRP), hepatic impairment (ALT/AST >2× ULN), renal impairment (serum creatinine > ULN), anemia (Hb <120 g/L in men; <110 g/L in women), and abnormal tumor markers. SAEs include severe allergic reactions (edema, asthma). Safety is assessed by physical examination, vital signs, laboratory tests (CBC/CRP, liver and renal function, electrolytes, fasting glucose, IgE, EKG), and AE/SAE questionnaires at Weeks 4, 12, 16, and 48; tumor markers, cardiac markers, DIC, and lipids are assessed at Week 48.

Results and safety

This study is still under way. Results are not available in the source record yet.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 6 Nov 2026.
Individual participant dataSharing planned: No. No IPD sharing is planned. The protocol does not include a data-sharing plan for individual participant data. Data will be stored securely with password protection and used only for this study; only aggregate/summary results will be published, and the trial will be registered publicly.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 11 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 6 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Incidence, severity, and relatedness of local and systemic adverse events and serious adverse events after intranasal UCMSC-Exo in early Parkinson's disease (time frame: From first dose through Week 48; safety assessments at Weeks 4, 12, 16, and 48). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07923838.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Nov 2026.