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Umbilical cord cell infusion aims to prevent painful mouth sores in transplant patients

NCT ID NCT07400328

Prevention Sponsor: The First Affiliated Hospital of Soochow University 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests whether a one-time infusion of amimestrocel, made from donated umbilical cord cells, can prevent severe mouth and gut sores in people receiving a stem cell transplant. About 22 adults will get the infusion before their transplant, and researchers will monitor for sores, pain, and side effects for up to 100 days. The goal is to see if this cell therapy reduces the rate of severe oral mucositis, a common and painful complication of transplant conditioning.

What this could mean

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

Active substance
amimestrocel (umbilical cord mesenchymal stem cells)
What this could lead to
If it works, this could offer a way to prevent painful mouth and gut sores in patients undergoing stem cell transplants, reducing pain and infection risk.
What could go wrong
This is a small, early-phase study with only 22 participants, so results may not apply to everyone. The treatment may not reduce severe mouth sores, and there could be 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 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 22 people

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

Started

Feb 2026

Expected to finish

Jan 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. Aged 18 to 65 years. 2. Planned to undergo myeloablative allogeneic hematopoietic stem cell transplantation. 3. The conditioning regimen must contain total body irradiation (TBI) and/or melphalan. 4. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1. 5. Adequate organ function defined as:Left ventricular ejection fraction (LVEF) ≥ 50%.Serum total bilirubin ≤ 1.5 × upper limit of normal (ULN).Serum creatinine ≤ 1.5 × ULN or creatinine clearance ≥ 60 mL/min. 6. Voluntarily signs the informed consent form. Exclusion Criteria: 1. History of allergy to mesenchymal stem cells or any component of the Amimestrocel injection preparation. 2. Presence of active, uncontrolled bacterial, fungal, or viral infection. 3. History of other malignancies within the past 5 years, except for cured carcinoma in situ or basal cell skin cancer. 4. Pregnant or lactating women, or those planning pregnancy during the study period. 5. Previous receipt of any cell therapy product. 6. Severe psychiatric disorder or cognitive impairment that would limit the ability to provide informed consent or comply with study procedures. 7. Any condition that, in the investigator's judgment, makes the subject unsuitable for study participation.

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Conditions

The condition(s) this trial relates to.

mucositis stomatitis gastrointestinal mucositis prevention target

As listed by the trial registrant

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

Gastrointestinal mucositis Hematopoietic stem cell transplantation Oral mucositis Stomatitis

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

  • First Affiliated Hospital of Soochow University

    RECRUITING

    Suzhu, Jiangsu, 215006, China

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