Heart FailureEarly Phase 1NCT07883317
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）
A Early Phase 1 study testing Exosome Preparation in people with Heart Failure, run by Yining Yang.
Trial summary
A single-center, randomized, double-blind, placebo-controlled, dose-escalation clinical study to evaluate the safety and tolerability of intravenous infusion of different doses of the investigational exosome preparation in heart failure subjects receiving left ventricular assist device therapy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Failure
- What is being tested?
- Exosome Preparation
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 24 participants
- Where
- No sites listed yet
- Study dates
- 15 Jan 2027to 15 Jan 2029
- Phase
- Early Phase 1
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subject or legal representative has signed the Informed Consent Form (ICF).
- Age ≥ 18 years.
- Body Surface Area (BSA) ≥ 1.2 m².
- NYHA Class III B or NYHA Class IV.
- Left ventricular ejection fraction (LVEF) ≤ 25%.
- a) Inotrope-dependent; OR b) Cardiac Index (CI) < 2.2 L/min/m² in the absence of inotropes, and the subject must also meet one of the following:
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- Receiving optimal medical management per current heart failure guidelines for at least 45 days out of the preceding 60 days, with evidence of treatment failure;
- Advanced heart failure for at least 14 days AND dependent on intra-aortic balloon pump (IABP) support for at least 7 days.
- Females of childbearing potential must agree to use adequate contraception throughout the study.
Who cannot join
- Heart failure caused by thyroid disease, hypertrophic obstructive cardiomyopathy, pericardial disease, amyloidosis or restrictive cardiomyopathy.
- History of any solid organ transplantation (including heart transplantation).
- Moderate to severe aortic regurgitation that was not corrected concomitantly at the time of LVAD implantation.
- Irreversible severe right heart failure that cannot be corrected by medications or right ventricular assist device.
- Pre-existing technical barriers at the time of LVAD implantation conferring an abnormally high surgical risk as judged by the heart team.
- Planned biventricular assist device (Bi-VAD) support prior to LVAD implantation.
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- Presence of an aortic mechanical valve that was not replaced with a bioprosthesis or sutured closed during LVAD implantation.
- Presence of any risk factor indicating severe end-organ dysfunction or failure:
- INR ≥2.0 not attributable to anticoagulation therapy
- Total bilirubin>43 μmol/L (2.5 mg/dL), shock liver, or biopsy-proven liver cirrhosis
- History of severe chronic obstructive pulmonary disease (COPD): FEV1/FVC<0.7 and FEV1<50% of predicted value
- Fixed pulmonary hypertension with latest pulmonary vascular resistance (PVR) ≥8 Wood units and no response to pharmacotherapy
- History of stroke within 90 days prior to enrollment; or cerebrovascular disease with severe (>80%) uncorrected carotid artery stenosis
- Serum creatinine ≥221 μmol/L (2.5 mg/dL) or requirement for chronic renal replacement therapy
- Severe peripheral vascular disease (PVD) with rest pain or limb ulceration
- Abnormal nutritional status: If only one test result is available, prealbumin<150 mg/L (15 mg/dL) OR albumin<30 g/L (3 g/dL); if both results are available, prealbumin<150 mg/L (15 mg/dL) AND albumin<30 g/L (3 g/L).
- Untreated abdominal aortic aneurysm (AAA) diagnosed within 6 months prior to enrollment with diameter>5 cm.
- Inability to tolerate anticoagulation, antiplatelet therapy, or any other perioperative/postoperative treatment required by the investigator based on the subject's condition.
- Platelet count <100×10⁹/L (100,000/μL).
- Known hypocoagulable or hypercoagulable state, such as disseminated intravascular coagulation, heparin-induced thrombocytopenia.
- Active uncontrolled systemic infection, including but not limited to sepsis, active infective endocarditis, and LVAD-related pump infection.
- Confirmed malignancy with estimated survival less than 1 year.
- Receipt of mechanical circulatory support other than intra-aortic balloon pump (IABP) at enrollment.
- Presence of psychiatric disorders, irreversible cognitive impairment or psychosocial problems that may impair protocol compliance and left ventricular assist system (LVAS) management.
- History of severe hypersensitivity to the investigational product (exosome formulation) or excipients.
- Participation in another interventional clinical trial (device/cell/biological product) within 30 days prior to enrollment.
- Female subjects who are pregnant or breastfeeding; positive pregnancy test at screening for women of childbearing potential.
- Any other condition judged by the investigator to render the subject unsuitable for participation in this study.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
A single-center, randomized, double-blind, placebo-controlled, dose-escalation clinical study to evaluate the safety and tolerability of intravenous infusion of different doses of the investigational exosome preparation in heart failure subjects receiving left ventricular assist device therapy.
Subjects will receive exosome or placebo once daily for 3 consecutive days, in addition to optimal medical therapy (OMT). The drug category, dosage and administration of OMT will be recorded as concomitant medications and entered into the Case Report Form (CRF). The OMT regimen (including drug type, dosage, route of administration, treatment duration, etc.) will be documented throughout the study. During the study, subjects will undergo efficacy and safety assessments and/or sample collection. After completion of treatment, follow-up visits will be conducted at Day 28, 6 months and 12 months.
- Conditions
- Heart Failure
- Being tested
- Exosome Preparation, Placebo
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exosome PreparationBiological
Subjects will receive exosome preparation once daily for 3 consecutive days
PlaceboOther
Subjects will receive placebo once daily for 3 consecutive days
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | Not described Receives: Biological: Exosome Preparation |
| Control group | Placebo comparator | Not described Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of treatment-related serious adverse events within Day 28 after administration of the investigational exosome preparation.
Measured: within Day 28 after administration of the investigational exosome preparation
Secondary outcomes (15)
Incidence of all adverse events (AEs) and serious adverse events (SAEs) within Day 28 after administration of the investigational exosome preparation.
Measured: within Day 28 after administration of the investigational exosome preparation.
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).
Measured: within 24 hours after administration of the investigational exosome preparation
Occurrence of clinically significant electrocardiographic abnormalities before and after administration of the investigational exosome preparation
Measured: Baseline (prior to study drug infusion), up to Day 28 post-administration
Occurrence of clinically significant echocardiographic abnormalities before and after administration of the investigational exosome preparation
Measured: Baseline (prior to study drug infusion), up to Day 28 post-administration
Laboratory abnormalities occurring before and after administration of the investigational exosome preparation
Measured: Baseline (prior to study drug infusion), up to Day 28 post-administration
Changes in vital signs (blood pressure, heart rate, respiratory rate, body temperature)
Measured: Baseline (prior to study drug infusion), up to Day 28 post-administration
Incidence of vital sign abnormalities
Measured: Baseline (prior to study drug infusion), up to Day 28 post-administration
Changes from baseline in Kansas City Cardiomyopathy Questionnaire (KCCQ) score
KCCQ is a patient-reported health status scale with scores ranging from 0 to 100; higher scores indicate better health-related quality of life.
Measured: At 6 months and 12 months after administration of the investigational exosome preparation
Changes from baseline in EuroQol 5-Dimension Questionnaire (EQ-5D) utility index
EQ-5D is a health status questionnaire. The utility index ranges from -0.594 to 1.0; higher utility index indicates better health status.
Measured: At 6 months and 12 months after administration of the investigational exosome preparation
Changes from baseline in New York Heart Association (NYHA) functional class
NYHA functional classification (Class I, II, III, IV) assessing heart failure symptom severity.
Measured: At 6 months and 12 months after administration of the investigational exosome preparation
Changes from baseline in NT-proBNP levels at 6 and 12 months after administration of the investigational exosome preparation
Measured: at 6 and 12 months after administration of the investigational exosome preparation
Changes from baseline in echocardiographic parameters including LVEF, LVEDD, and LVESD at 6 and 12 months after administration of the investigational exosome preparation
Measured: at 6 and 12 months after administration of the investigational exosome preparation
Changes from baseline in 6-minute walk test (6MWT) distance at 6 and 12 months after administration of the investigational exosome preparation
Measured: at 6 and 12 months after administration of the investigational exosome preparation
Time from administration of the investigational exosome preparation to the first occurrence of all-cause death or debilitating stroke
Measured: at 12 months after administration of the investigational exosome preparation
Time from administration of the investigational exosome preparation to all-cause death
Measured: at 12 months after administration of the investigational exosome preparation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Oct 2026
- Study start15 Jan 2027 (estimated)
- Primary completion15 Feb 2028 (estimated)
- Study completion15 Jan 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart FailureStudies of the same condition, open and under way.
- 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
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yining Yang
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Yining Yang, People's Hospital of Xinjiang Uygur Autonomous Region
- Investigators
- Yining Yang, MD, PhD, Principal investigator, People's Hospital of Xinjiang Uygur Autonomous Region
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07883317
- Sponsor's protocol ID
- RESTORATION
- Status last verified
- Oct 2026
- First submitted
- 2 Oct 2026
- Last updated
- 20 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 20 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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）
- ClinicalTrials.gov ID
- NCT07883317
- Acronym / sponsor ID
- RESTORATION
- Conditions
- Heart Failure
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- Yining YangUniversity, hospital or other
- Study start
- 15 Jan 2027 (estimated)
- Primary completion
- 15 Feb 2028 (estimated)
- Study completion
- 15 Jan 2029 (estimated)
- First posted
- 20 Oct 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.
A single-center, randomized, double-blind, placebo-controlled, dose-escalation clinical study to evaluate the safety and tolerability of intravenous infusion of different doses of the investigational exosome preparation in heart failure subjects receiving left ventricular assist device therapy.
Subjects will receive exosome or placebo once daily for 3 consecutive days, in addition to optimal medical therapy (OMT). The drug category, dosage and administration of OMT will be recorded as concomitant medications and entered into the Case Report Form (CRF). The OMT regimen (including drug type, dosage, route of administration, treatment duration, etc.) will be documented throughout the study. During the study, subjects will undergo efficacy and safety assessments and/or sample collection. After completion of treatment, follow-up visits will be conducted at Day 28, 6 months and 12 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Biological: Exosome Preparation |
| Control group | Placebo comparator | Other: Placebo |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Subject or legal representative has signed the Informed Consent Form (ICF).
- Age ≥ 18 years.
- Body Surface Area (BSA) ≥ 1.2 m².
- NYHA Class III B or NYHA Class IV.
- Left ventricular ejection fraction (LVEF) ≤ 25%.
Key exclusion criteria (28 listed)
- Heart failure caused by thyroid disease, hypertrophic obstructive cardiomyopathy, pericardial disease, amyloidosis or restrictive cardiomyopathy.
- History of any solid organ transplantation (including heart transplantation).
- Moderate to severe aortic regurgitation that was not corrected concomitantly at the time of LVAD implantation.
- Irreversible severe right heart failure that cannot be corrected by medications or right ventricular assist device.
- Pre-existing technical barriers at the time of LVAD implantation conferring an abnormally high surgical risk as judged by the heart team.
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 |
|---|---|---|
| Exosome PreparationSubjects will receive exosome preparation once daily for 3 consecutive days | Biological | Intervention group |
| PlaceboSubjects will receive placebo once daily for 3 consecutive days | Other | Control group |
Primary outcome
Incidence of treatment-related serious adverse events within Day 28 after administration of the investigational exosome preparation.
Time frame: within Day 28 after administration of the investigational exosome preparation
15 secondary outcomes
Incidence of all adverse events (AEs) and serious adverse events (SAEs) within Day 28 after administration of the investigational exosome preparation.
Time frame: within Day 28 after administration of the investigational exosome preparation.
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).
Time frame: within 24 hours after administration of the investigational exosome preparation
Occurrence of clinically significant electrocardiographic abnormalities before and after administration of the investigational exosome preparation
Time frame: Baseline (prior to study drug infusion), up to Day 28 post-administration
Occurrence of clinically significant echocardiographic abnormalities before and after administration of the investigational exosome preparation
Time frame: Baseline (prior to study drug infusion), up to Day 28 post-administration
Laboratory abnormalities occurring before and after administration of the investigational exosome preparation
Time frame: Baseline (prior to study drug infusion), up to Day 28 post-administration
Changes in vital signs (blood pressure, heart rate, respiratory rate, body temperature)
Time frame: Baseline (prior to study drug infusion), up to Day 28 post-administration
Incidence of vital sign abnormalities
Time frame: Baseline (prior to study drug infusion), up to Day 28 post-administration
Changes from baseline in Kansas City Cardiomyopathy Questionnaire (KCCQ) score
Time frame: At 6 months and 12 months after administration of the investigational exosome preparation
Changes from baseline in EuroQol 5-Dimension Questionnaire (EQ-5D) utility index
Time frame: At 6 months and 12 months after administration of the investigational exosome preparation
Changes from baseline in New York Heart Association (NYHA) functional class
Time frame: At 6 months and 12 months after administration of the investigational exosome preparation
Changes from baseline in NT-proBNP levels at 6 and 12 months after administration of the investigational exosome preparation
Time frame: at 6 and 12 months after administration of the investigational exosome preparation
Changes from baseline in echocardiographic parameters including LVEF, LVEDD, and LVESD at 6 and 12 months after administration of the investigational exosome preparation
Time frame: at 6 and 12 months after administration of the investigational exosome preparation
Changes from baseline in 6-minute walk test (6MWT) distance at 6 and 12 months after administration of the investigational exosome preparation
Time frame: at 6 and 12 months after administration of the investigational exosome preparation
Time from administration of the investigational exosome preparation to the first occurrence of all-cause death or debilitating stroke
Time frame: at 12 months after administration of the investigational exosome preparation
Time from administration of the investigational exosome preparation to all-cause death
Time frame: at 12 months after administration of the investigational exosome preparation
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 20 Oct 2026.
- Individual participant dataSharing planned: Yes
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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.
Yining Yang, MD, PhD principal investigator
People's Hospital of Xinjiang Uygur Autonomous Region
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Exosome Preparation in people with Heart Failure, run by Yining Yang.
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 9 inclusion and 28 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: opening soon, as of the sponsor's last update on 20 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
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?
Contact Jing Tao, MD, PhD (8618935903292, taojing_xj@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of treatment-related serious adverse events within Day 28 after administration of the investigational exosome preparation. (time frame: within Day 28 after administration of the investigational exosome preparation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 20 Oct 2026.