Clinical Safety and Efficacy of Umbilical Cord Mesenchymal Stromal Cells-derived Exosomes in Patients With Parkinson's Disease
NCT07923838, Phase 1, Phase 2, Active not recruiting, Shanghai Jiao Tong University School of Medicine
Trial 10
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
| Field | Value | Source |
|---|---|---|
| Title | Clinical Safety and Efficacy of Umbilical Cord Mesenchymal Stromal Cells-derived Exosomes in Patients With Parkinson's Disease | ClinicalTrials.gov |
| NCT number | NCT07923838 | ClinicalTrials.gov |
| Status | Active not recruiting | ClinicalTrials.gov |
| Phases | Phase 1, Phase 2 | ClinicalTrials.gov |
| Enrollment | 9 participants, actual | ClinicalTrials.gov |
| Lead sponsor | Shanghai Jiao Tong University School of Medicine | ClinicalTrials.gov |
| Conditions | Parkinson Disease (PD) | ClinicalTrials.gov |
| Interventions | Umbilical cord mesenchymal stromal cell-derived exosomes (UCMSC-Exo) | ClinicalTrials.gov |
| First posted | 2026-11-06 | ClinicalTrials.gov |
| Last updated | 2026-11-06 | ClinicalTrials.gov |
Registered outcomes 1
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description | Source |
|---|---|---|---|---|
| Primary | Incidence, severity, and relatedness of local and systemic adverse events and serious adverse events after intranasal UCMSC-Exo in early Parkinson's disease | 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. | ClinicalTrials.gov |
Outcomes 0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as | Source |
|---|
Results by group 0
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units | Source |
|---|
Participant flow 0
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted | Source |
|---|
Adverse events 0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events | Source |
|---|
Adverse event totals 0
The totals the trial posted for each group.
| Total | Group | Affected | At risk | Source |
|---|
Papers 0
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as | Source |
|---|
Grants 0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years | Source |
|---|
Trial comparisons 0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|
Tests 0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
| Test | Named as | Source |
|---|
Source 5
| Field | Value | Source |
|---|---|---|
| Release | trials-2026-11-12-0.4.0 | ClinicalTrials.gov |
| Release manifest SHA-256 | 0f4a8d8c48aee2a7573ae0fa94ecbeab70c1adbe449bbc95c424bc7d3e97b9d4 | ClinicalTrials.gov |
| Registry capture | 2026-11-12 | ClinicalTrials.gov |
| Results copy, AACT | 2026-03-23 | ClinicalTrials.gov |
| NIH clinical studies file | 2026-11-13 | ClinicalTrials.gov |
Release trials-2026-11-12-0.4.0
ClinicalTrials.gov's posted results, through CTTI's AACT: ClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299 ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
ClinicalTrials.gov: none stated ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
NIH RePORTER's clinical studies and project files: Public domain (NIH RePORTER)