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Could tiny stem cell particles help control diabetes?

NCT ID NCT07693036

Disease control Sponsor: Peking University First Hospital Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jul 09, 2026 · Last updated Jul 10, 2026 · Updated 1 time

Summary

This trial investigates whether exosomes—tiny particles from human umbilical cord stem cells—can safely improve blood sugar control in adults with type 2 diabetes. Participants receive weekly intravenous infusions of the exosome product or a control for eight weeks. The study measures changes in HbA1c, a key marker of long-term blood sugar levels, and monitors for side effects.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
human umbilical cord mesenchymal stem cell-derived exosomes (GoldenExo NATX)
What this could lead to
If successful, this could point toward a new way to improve blood sugar control and reduce diabetes complications without daily injections.
What could go wrong
This is an early-phase trial with a small number of participants, so results may not apply to everyone. Exosome therapy is experimental and could have unknown side effects.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1/2

Runs two stages together: safety and dose first, then whether the treatment works.

Participants

About 66 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jun 2026

Expected to finish

Jun 2028

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 65 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Age 18-65 years, diagnosed with T2DM for ≥5 years (\<20 years). 2. Regular diet and exercise control combined with the following intensive treatment regimens, with screening HbA1c remaining between 7.5% and 9.0% (FBG \<13.9mmol/L):Stable dose of insulin (basal or premixed) (\<1.5u/kg·d) combined with ≥1 oral antidiabetic drug (OAD) (e.g., Metformin, SGLT2i) for ≥3 months; or Insulin combined with a GLP-1RA (maximum tolerated dose, ≤1mg Qw); or GLP-1RA (maximum tolerated dose, ≤1mg Qw) combined with ≥1 OAD for ≥3 months; or Stable dose of ≥3 OADs (must include Metformin) for ≥3 months. 3. Fasting C-peptide ≥1.0 ng/mL. 4. Glutamic acid decarboxylase (GAD) antibody and Islet cell antibody (IAA) negative. 5. Body Mass Index (BMI) 18.5-35 kg/m ². 6. Subjects voluntarily participate in the study and sign the informed consent form. 7. Female subjects of childbearing potential and non-sterilized male subjects must agree to use highly effective contraceptive methods during the study period and for 1 year following the final infusion. Exclusion Criteria: 1. Type 1 diabetes or other specific types of diabetes. 2. Occurrence of severe hypoglycemia or diabetic ketoacidosis within the past 6 months. 3. Severe cardiovascular/cerebrovascular diseases, hepatic or renal insufficiency (e.g., eGFR \<30 mL/min·1.73m²). 4. Active malignancy, coagulation disorders, immune system diseases. 5. Pregnant or lactating women. 6. Individuals with allergic constitution. 7. Exclusion of subjects currently participating in other clinical trials. 8. Subjects deemed unsuitable for participation by the investigator.

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Conditions

The condition(s) this trial relates to.

type 2 diabetes mellitus

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Type 2 diabetes mellitus (T2DM)

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Peking University first Hospital

    RECRUITING

    Beijing, China

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