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Not yet recruitingNCT07883317Updated Oct 20, 2026

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）

An Early Phase 1 interventional study of Exosome Preparation and Placebo in Heart Failure, sponsored by Yining Yang. Not yet recruiting. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-20.

Sponsored by Yining Yang · Early Phase 1, Interventional, and Treatment

Updated Oct 20, 2026Newly registeredGo to Updates ↓
Phase
Early Phase 1
Study type
Interventional
Enrollment
24
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

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.

02

Conditions studied

  • Heart Failure

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03

In context

Heart Failure

5,803 studies on the registry are indexed under Heart Failure; 1,222 are open to participants now.

This study's planned enrollment of 24 is below the median of 72 across 3,790 interventional studies indexed under Heart Failure.

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Lead sponsor

This is the only study on the registry with Yining Yang as lead sponsor.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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.

Inclusion criteria

  1. Subject or legal representative has signed the Informed Consent Form (ICF).
  2. Age ≥ 18 years.
  3. Body Surface Area (BSA) ≥ 1.2 m².
  4. NYHA Class III B or NYHA Class IV.
  5. Left ventricular ejection fraction (LVEF) ≤ 25%.

  6. 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:

    • 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.
  7. Females of childbearing potential must agree to use adequate contraception throughout the study.

Exclusion criteria

Exclusion Criteria:

  1. Heart failure caused by thyroid disease, hypertrophic obstructive cardiomyopathy, pericardial disease, amyloidosis or restrictive cardiomyopathy.
  2. History of any solid organ transplantation (including heart transplantation).
  3. Moderate to severe aortic regurgitation that was not corrected concomitantly at the time of LVAD implantation.
  4. Irreversible severe right heart failure that cannot be corrected by medications or right ventricular assist device.
  5. Pre-existing technical barriers at the time of LVAD implantation conferring an abnormally high surgical risk as judged by the heart team.
  6. Planned biventricular assist device (Bi-VAD) support prior to LVAD implantation.
  7. Presence of an aortic mechanical valve that was not replaced with a bioprosthesis or sutured closed during LVAD implantation.

  8. Presence of any risk factor indicating severe end-organ dysfunction or failure:

    1. INR ≥2.0 not attributable to anticoagulation therapy
    2. Total bilirubin>43 μmol/L (2.5 mg/dL), shock liver, or biopsy-proven liver cirrhosis
    3. History of severe chronic obstructive pulmonary disease (COPD): FEV1/FVC\<0.7 and FEV1\<50% of predicted value
    4. Fixed pulmonary hypertension with latest pulmonary vascular resistance (PVR) ≥8 Wood units and no response to pharmacotherapy
    5. History of stroke within 90 days prior to enrollment; or cerebrovascular disease with severe (>80%) uncorrected carotid artery stenosis
    6. Serum creatinine ≥221 μmol/L (2.5 mg/dL) or requirement for chronic renal replacement therapy
    7. Severe peripheral vascular disease (PVD) with rest pain or limb ulceration
  9. 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).
  10. Untreated abdominal aortic aneurysm (AAA) diagnosed within 6 months prior to enrollment with diameter>5 cm.
  11. Inability to tolerate anticoagulation, antiplatelet therapy, or any other perioperative/postoperative treatment required by the investigator based on the subject's condition.
  12. Platelet count \<100×10⁹/L (100,000/μL).
  13. Known hypocoagulable or hypercoagulable state, such as disseminated intravascular coagulation, heparin-induced thrombocytopenia.
  14. Active uncontrolled systemic infection, including but not limited to sepsis, active infective endocarditis, and LVAD-related pump infection.
  15. Confirmed malignancy with estimated survival less than 1 year.
  16. Receipt of mechanical circulatory support other than intra-aortic balloon pump (IABP) at enrollment.
  17. Presence of psychiatric disorders, irreversible cognitive impairment or psychosocial problems that may impair protocol compliance and left ventricular assist system (LVAS) management.
  18. History of severe hypersensitivity to the investigational product (exosome formulation) or excipients.
  19. Participation in another interventional clinical trial (device/cell/biological product) within 30 days prior to enrollment.
  20. Female subjects who are pregnant or breastfeeding; positive pregnancy test at screening for women of childbearing potential.
  21. Any other condition judged by the investigator to render the subject unsuitable for participation in this study.
05

Study design

Phase
Early Phase 1
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
24 participants (estimated)

Study arms

  • Experimental
    Intervention group

    Biological: Exosome Preparation

  • Placebo comparator
    Control group

    Other: Placebo

Interventions

  • BiologicalExosome Preparation

    Subjects will receive exosome preparation once daily for 3 consecutive days

  • OtherPlacebo

    Subjects will receive placebo once daily for 3 consecutive days

06

What researchers measure

Primary outcomes

  1. 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

Secondary outcomes

  1. 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.

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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

  7. Incidence of vital sign abnormalities

    Time frame: Baseline (prior to study drug infusion), up to Day 28 post-administration

  8. 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.

    Time frame: At 6 months and 12 months after administration of the investigational exosome preparation

  9. 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.

    Time frame: At 6 months and 12 months after administration of the investigational exosome preparation

  10. Changes from baseline in New York Heart Association (NYHA) functional class

    NYHA functional classification (Class I, II, III, IV) assessing heart failure symptom severity.

    Time frame: At 6 months and 12 months after administration of the investigational exosome preparation

  11. 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

  12. 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

  13. 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

  14. 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

  15. Time from administration of the investigational exosome preparation to all-cause death

    Time frame: at 12 months after administration of the investigational exosome preparation

07

Study locations

No study locations are listed for this record.

08

References and documents

Individual participant data

Plan to share: Yes

Supporting information: Study protocol, Statistical analysis plan

No publications or documents are linked to this record.

09

Updates

1 registry update since Sep 25, 2026
Registered
First appeared on the registry. No changes since
Oct 20, 2026
Show all 1 update
  1. Oct 20, 2026
    First appeared on the registry

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 ↗

10

Registry details

Key details

Study ID
NCT07883317
Lead sponsor
Yining Yang
Responsible party
Yining Yang (President, People's Hospital of Xinjiang Uygur Autonomous Region) — Sponsor-investigator
First posted
Oct 20, 2026
Start date
Jan 15, 2027 (estimated)
Primary completion
Feb 15, 2028 (estimated)
Completion
Jan 15, 2029 (estimated)
Last update
Oct 20, 2026

Study contacts

Jing Tao, MD, PhD
Contact
taojing_xj@163.com
8618935903292
Yining Yang, MD, PhD
principal investigator · People's Hospital of Xinjiang Uygur Autonomous Region

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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