A Phase 1/2 interventional study of Umbilical cord mesenchymal stromal cell-derived exosomes (UCMSC-Exo) in Parkinson Disease (PD), sponsored by Shanghai Jiao Tong University School of Medicine. Active, not recruiting at 1 site in China. Open to participants aged 50 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-11-06.
Sponsored by Shanghai Jiao Tong University School of Medicine · Phase 1/2, Interventional, and Treatment
Among 278 studies in Parkinson Disease with a site in China — 129 open to participants now, 136 under way, 3 of them phase 3. Parkinson Disease · China.
Among the 278 studies in Parkinson Disease with a site in China, this one is the 191st largest by enrollment of the 210 interventional ones that give a count, is one of 31 that started in 2024, is one of 9 in phase 1/2, reaches primary completion later than 95 of the 135 other live ones, and was the 278th registered.
4,573 studies on the registry are indexed under Parkinson Disease; 1,086 are open to participants now.
This study's enrollment of 9 is below the median of 40 across 3,353 interventional studies indexed under Parkinson Disease.
Browse Parkinson Disease studies →129 of the 278 studies in Parkinson Disease with a site in China are open now.
A study can be open while its sites in China have not opened yet or have stopped. Only those recruiting at a site in China →
Of the 748 Parkinson Disease studies recruiting now, 311 (42%) set no upper age limit and 127 (17%) stop at 75 or younger; 63 take children under 18; 189 take healthy volunteers.
This study: 50 Years to 75 Years · all sexes · no healthy volunteers.
The full table on the hub →278 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 48 · Phase 2 27 · Phase 3 23 · Phase 4 11
First in 2003; this study’s year is marked. 31 started in 2024.
Median enrollment 48 across the 210 interventional studies, 215 across the 68 observational. Of the 95 that completed or were terminated, 19 (20%) have results posted.
63 of 278 have an industry lead sponsor. The 10 most frequent:
Shanghai Jiao Tong University School of Medicine is the lead sponsor of 374 studies on the registry; 110 are open to participants now.
Shanghai Jiao Tong University School of Medicine has 1 study filed under Parkinson Disease — fewer than ten, so there is no comparison to draw.
41 of the studies in Parkinson Disease with a site in China that are under way reach primary completion within a year, 1 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT07725562Phase 3Zhejiang Vimgreen Pharmaceuticals, Ltd.VG081821AC Tablets for Early to Mid-stage Parkinson's Disease | 2027-10-01 |
| NCT07028632iRegene Therapeutics Co., Ltd.The Safety, Feasibility and Efficacy of NouvNeu001 for Parkinson's Disease | 2026-12 |
| NCT07604116Synusight Biotech (Shanghai) Co., Ltd.A Study to Evaluate Satety, Tolerability, Biodistribution, Radiation Dosimetry, and Pharmacokinetics of SST001 in Healthy Volunteers, Patients With PD and Patients With MSA | 2026-12 |
| NCT06642454Anhui Medical UniversityA Randomized Double-Blind Active-Controlled Crossover Trial of Respiratory-Gated Versus Non-Gated Transcutaneous Auricular Vagus Nerve Stimulation for the Treatment of Motor and Non-Motor Symptoms in Parkinson's Disease | 2026-12-01 |
| NCT07384429YangPanEffects of Lemborexant on Motor-sleep Comorbidity in Parkinson's Disease | 2026-12-01 |
Among the 278 studies in Parkinson Disease with a site in China, from their registry updates:
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:
Participants will:
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
8、Severe psychiatric symptoms or hallucinations.
9、History of or markedly abnormal tumor markers.
10、Severe systemic infection within the past 3 months.
11、MRI , including but not limited to cardiac pacemaker, claustrophobia, or implanted metal devices.
12、Positive infectious disease screening for , , , 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.
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Short tests of memory and thinking, each scored out of 30. Lower scores suggest more difficulty; criteria give a range, either to include people with memory problems or to leave them out.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
The number of neutrophils, white blood cells that help fight infection, in a given amount of blood. Too few raises the risk of infection.
It is a count, not a percentage of the white cells. Limits are written in units that mean the same: ≥ 1.5 × 10⁹/L is ≥ 1,500 per mm³ (µL). Each lab has its own reference range.
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
MMSE and MoCA
Short tests of memory and thinking, each scored out of 30. Lower scores suggest more difficulty; criteria give a range, either to include people with memory problems or to leave them out.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Autoimmune disease
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Absolute neutrophil count (ANC)
The number of neutrophils, white blood cells that help fight infection, in a given amount of blood. Too few raises the risk of infection.
It is a count, not a percentage of the white cells. Limits are written in units that mean the same: ≥ 1.5 × 10⁹/L is ≥ 1,500 per mm³ (µL). Each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Platelets
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ULN (upper limit of normal)
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ALT and AST (liver enzymes)
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis B tests
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis C tests
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
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.
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.
Biological: 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.
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.
Time frame: From first dose through Week 48; safety assessments at Weeks 4, 12, 16, and 48
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: 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.
Started Oct 2024 (actual). Primary completion is estimated for Jun 2027, 32 months after the start.
Of 55 phase 1/2 interventional studies under Parkinson Disease, half reached primary completion within 25 months of starting (the median), counting those still running; a quarter within 12 and three quarters within 53. This study's planned 32 months is above that.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is active, not recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
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Shanghai Jiao Tong University School of Medicine →