Who sponsors or initiates the studies listed on this page?

Sponsor and investigator information is taken from each study's public registry record. The registered sponsor or institution is identified in the official record, and Echo Biotech should not be treated as the sponsor unless the registry explicitly states that role.

What is Echo Biotech's role in the listed clinical studies?

Echo Biotech's role is limited to the contribution disclosed for each study and may involve technical, material, manufacturing, or analytical collaboration. The official registry remains the authoritative source for sponsor, investigator, recruitment, and study-status information.

Does clinical-trial registration mean that a treatment or product has been approved?

No. Registration indicates that a study has been listed in a public registry. It does not by itself establish regulatory approval, market authorization, proven safety or efficacy, or endorsement by the registry. Study status and results should be checked in the official record.

Clinical Trials & Translational Research

Clinical Translation

Quick Facts

Publicly Registered Studies: Summarizes publicly registered collaborative exosome clinical studies.
Translational Collaboration: Connects exosome platform capabilities, quality control and clinical research needs.
Registry Verification: Directs users to ClinicalTrials.gov as the authoritative source.

Clinical Translation Overview

Echo Biotech works with leading academic hospitals to support publicly registered, investigator-led clinical studies evaluating human umbilical cord mesenchymal stem cell-derived exosomes across metabolic and neurological conditions.

The studies shown below are sponsored and led by the respective medical institutions. Echo Biotech is publicly listed as a collaborator. Registry records remain the authoritative source.

Publicly registered collaborative studies: 3

Total planned enrollment across studies: 137

Metabolic and neurological indications: 3

Administration routes under evaluation: 2

Evidence, transparency and responsible translation

Our role is to contribute exosome platform capabilities and technical collaboration within studies governed by hospital investigators, ethics requirements and public registration.

Science-led study design: Clinical objectives focus on safety, tolerability and preliminary efficacy, using defined study designs and outcome measures.

Quality and traceability: Product preparation and analytical controls are supported by Echo Biotech's exosome manufacturing and quality platforms.

Public registry disclosure: Study status, sponsors, enrollment targets and protocol details are linked directly to public ClinicalTrials.gov records.

Collaborative clinical research portfolio

Each study is presented as registered. No clinical outcomes or efficacy conclusions are implied, and no results have been posted for these studies at the time of this page review.

Registry information reviewed: 30 July 2026

Three studies, complementary translational questions

The portfolio explores different conditions, routes and study designs while maintaining a common emphasis on safety, rigorous assessment and prospective follow-up.

Study 01 · Metabolic Disease | NCT07693036 · HOPE-T2DM | hUC-MSC-Exosomes for Type 2 Diabetes | Official title: An Exploratory Clinical Study Assessing the Safety and Preliminary Efficacy of Human Umbilical Cord Mesenchymal Stem Cell-Derived Exosomes in the Treatment of Adult Type 2 Diabetes Mellitus | Status: Recruiting | Condition: Type 2 Diabetes Mellitus | Design: Sequential dose escalation + randomized comparative stage | Route: Intravenous administration | Planned enrollment: 66 | Sponsor: Peking University First Hospital | Echo Biotech role: Publicly listed collaborator | A two-stage clinical study evaluating safety and preliminary efficacy in adults with type 2 diabetes. The first stage uses sequential dose escalation; the second stage is designed as a randomized, blinded, active-comparator study. | Sponsor: Peking University First Hospital | Planned Enrollment: 66 participants | Treatment Schedule: Weekly for 8 weeks | Primary Endpoint: HbA1c change at Week 8 | Study design: Stage 1 includes three sequential dose cohorts. Subject to safety review, Stage 2 plans a 2:1 randomized comparison between exosome treatment and an active comparator. | Clinical focus: Safety, glycemic control, pancreatic islet function, metabolic parameters and longer-term follow-up are evaluated through defined clinical measures.

Study 02 · Neuroimmunology | NCT07131683 · MESAE | hUC-MSC-Exosomes for Autoimmune Encephalitis | Official title: Human Umbilical Cord Mesenchymal Stem Cell-derived Exosomes for Autoimmune Encephalitis: a Phase I/IIa Clinical Trial | Status: Recruiting | Condition: Autoimmune Encephalitis | Design: Phase I/IIa dose escalation + blinded expansion | Route: Intranasal administration | Planned enrollment: 38 | Sponsor: Xuanwu Hospital, Beijing | Echo Biotech role: Publicly listed collaborator | A multicenter clinical program evaluating intranasal hUC-MSC-derived exosomes for safety, tolerability, dose exploration and preliminary clinical outcomes in autoimmune encephalitis. | Sponsor: Xuanwu Hospital, Beijing | Planned Enrollment: 38 participants | Administration: Intranasal, 4-week treatment | Primary Measures: DLT and mRS at 24 weeks | Study design: Dose-escalation cohorts are followed by a randomized, double-blind, placebo-controlled expansion phase, with dose selection informed by safety review. | Clinical focus: Safety and neurological function are assessed using mRS, CASE, ADL, MMSE, MoCA and relapse-related measures.

Study 03 · Neurodegeneration | NCT07638813 | MSC-Exosome Therapy for Frontotemporal Dementia | Official title: A Randomized, Double-Blind, Placebo-Controlled Trial to Evaluate the Safety and Efficacy of Umbilical Cord Mesenchymal Stem Cell-Derived Exosomes Via Intranasal Administration in Patients With Frontotemporal Dementia | Status: Recruiting | Condition: Frontotemporal Dementia | Design: Phase I/II randomized, double-blind, placebo-controlled | Route: Intranasal administration | Planned enrollment: 33 | Sponsor: Ruijin Hospital | Echo Biotech role: Publicly listed collaborator | A three-arm study evaluating two intranasal dosing schedules against placebo in people with frontotemporal dementia, with a safety lead-in before enrollment in the higher-frequency arm. | Sponsor: Ruijin Hospital | Planned Enrollment: 33 participants | Treatment Period: Intranasal for 24 weeks | Primary Measures: Clinical function and safety | Study design: Randomized, double-blind and placebo-controlled, with low-frequency and high-frequency intranasal administration groups plus placebo. | Clinical focus: The study evaluates change in CDR plus NACC FTLD score, treatment-emergent adverse events and exploratory structural and functional neuroimaging outcomes.

Connecting platform capabilities with clinical research

Echo Biotech supports translational collaborations through integrated exosome preparation, analytical characterization and technical development capabilities.

Scientific alignment: Define the clinical question, exosome source, delivery route and critical product attributes with investigators.

Process and quality strategy: Establish scalable preparation, purification, formulation and analytical controls appropriate to the study.

Study material support: Prepare characterized investigational materials and study documentation within the agreed collaboration framework.

Ongoing technical support: Support product-related technical questions, quality review and translational learning throughout the study.

Clinical registry records are the authoritative source

Clinical study information changes over time. Visitors should refer to ClinicalTrials.gov for the most recent recruitment status, eligibility criteria, locations, contacts and protocol information.

Study sponsorship and medical decisions remain with the named clinical institutions and investigators.

Registration does not establish safety, efficacy, regulatory approval or commercial availability.

Participation inquiries should be directed to the study contacts listed in each official registry record.

Verify study information: Open the official ClinicalTrials.gov records to review current status, contacts, eligibility and full protocol details.

Explore translational exosome collaborations

Connect with our team to discuss research collaboration, CMC development, quality analytics and scalable exosome manufacturing.

Important Disclaimer

The information on this page is provided for scientific and corporate communication purposes only. The products and interventions described are investigational and are not represented as approved, safe or effective for routine clinical use. Study information is summarized from public registry records and may change.

FAQ

Who sponsors or initiates the studies listed on this page?: Sponsor and investigator information is taken from each study's public registry record. The registered sponsor or institution is identified in the official record, and Echo Biotech should not be treated as the sponsor unless the registry explicitly states that role.
What is Echo Biotech's role in the listed clinical studies?: Echo Biotech's role is limited to the contribution disclosed for each study and may involve technical, material, manufacturing, or analytical collaboration. The official registry remains the authoritative source for sponsor, investigator, recruitment, and study-status information.
Does clinical-trial registration mean that a treatment or product has been approved?: No. Registration indicates that a study has been listed in a public registry. It does not by itself establish regulatory approval, market authorization, proven safety or efficacy, or endorsement by the registry. Study status and results should be checked in the official record.