Trial · NCT07883317
A First-in-Human Study to Evaluate the Safety and Efficacy of Left Ventricular Assist Device Combined With Exosome Therapy for Patients With Heart Failure（RESTORATION）
NCT07883317, Early phase 1, Not yet recruiting, Yining Yang
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. A First-in-Human Study to Evaluate the Safety and Efficacy of Left Ventricular Assist Device Combined With Exosome Therapy for Patients With Heart Failure（RESTORATION）. Trials, record NCT07883317. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT07883317
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A First-in-Human Study to Evaluate the Safety and Efficacy of Left Ventricular Assist Device Combined With Exosome Therapy for Patients With Heart Failure（RESTORATION）
- NCT number
- NCT07883317
- Status
- Not yet recruiting
- Phases
- Early phase 1
- Enrollment
- 24 participants, estimated
- Lead sponsor
- Yining Yang
- Conditions
- Heart Failure
- Interventions
- Exosome Preparation, Placebo
- First posted
- 2026-10-20
- Last updated
- 2026-10-20
Source ClinicalTrials.gov
Registered outcomes16
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Incidence of treatment-related serious adverse events within Day 28 after administration of the investigational exosome preparation. | within Day 28 after administration of the investigational exosome preparation | |
| Secondary | Incidence of all adverse events (AEs) and serious adverse events (SAEs) within Day 28 after administration of the investigational exosome preparation. | within Day 28 after administration of the investigational exosome preparation. | |
| Secondary | Incidence and severity of infusion-related reactions within 24 hours after administration of the investigational exosome preparation, including fever, chills, hypotension, hypersensitivity reactions, and cytokine release syndrome (CRS). | within 24 hours after administration of the investigational exosome preparation | |
| Secondary | Occurrence of clinically significant electrocardiographic abnormalities before and after administration of the investigational exosome preparation | Baseline (prior to study drug infusion), up to Day 28 post-administration | |
| Secondary | Occurrence of clinically significant echocardiographic abnormalities before and after administration of the investigational exosome preparation | Baseline (prior to study drug infusion), up to Day 28 post-administration | |
| Secondary | Laboratory abnormalities occurring before and after administration of the investigational exosome preparation | Baseline (prior to study drug infusion), up to Day 28 post-administration | |
| Secondary | Changes in vital signs (blood pressure, heart rate, respiratory rate, body temperature) | Baseline (prior to study drug infusion), up to Day 28 post-administration | |
| Secondary | Incidence of vital sign abnormalities | Baseline (prior to study drug infusion), up to Day 28 post-administration | |
| Secondary | Changes from baseline in Kansas City Cardiomyopathy Questionnaire (KCCQ) score | At 6 months and 12 months after administration of the investigational exosome preparation | KCCQ is a patient-reported health status scale with scores ranging from 0 to 100; higher scores indicate better health-related quality of life. |
| Secondary | Changes from baseline in EuroQol 5-Dimension Questionnaire (EQ-5D) utility index | At 6 months and 12 months after administration of the investigational exosome preparation | EQ-5D is a health status questionnaire. The utility index ranges from -0.594 to 1.0; higher utility index indicates better health status. |
1 to 10 of 16Source ClinicalTrials.gov
See all 16 registered outcomesOutcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
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.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.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.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT07883317
GET https://conductscience.org/api/trials/v1/NCT07883317/registered