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A drug after transplant may stop scleroderma from coming back

NCT ID NCT07734012

Disease control Sponsor: Ottawa Hospital Research Institute Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 29, 2026 · Last updated Aug 07, 2026 · Updated 2 times

Summary

This pilot trial tests whether giving the immunosuppressant drug mycophenolate mofetil (MMF) for six months after a stem cell transplant can prevent systemic sclerosis from relapsing. Six adults with scleroderma who are undergoing a stem cell transplant will take MMF starting 90 days after the transplant. The study aims to see if a larger trial is feasible and whether this approach reduces signs of disease activity.

What this could mean

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

Active substance
mycophenolate mofetil (MMF), an immunosuppressant drug
What this could lead to
If this approach works, it could offer a way to prevent disease relapse after stem cell transplant for systemic sclerosis.
What could go wrong
This is a very small pilot study with only 6 participants, so results may not apply broadly. MMF can cause side effects like low blood counts and kidney problems.

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 6 people

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

Expected to start

Aug 2026

An estimate. Start dates often move.

Expected to finish

Dec 2029

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 years and older

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: * Consenting participants 18 years of age or older who are initiating AHSCT at The Ottawa Hospital for management of SSc. Exclusion Criteria: * Exclusion criteria are focused on patient safety, namely inability to receive treatment with MMF due to contraindications as determine at time of randomization (day 90 / clinic visit #3) including: * Renal insufficiency (eGFR \<25 mL/minute/1.73m2) or * Neutropenia (ANC \<1.0 x 103/mcL) or * Thrombocytopenia (platelet count \<50 000/mcL) * Previously documented intolerance. * Pregnant or breastfeeding - Women of childbearing potential who are not willing to use a highly effective method of contraception for the duration of study participation will be excluded

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Conditions

The condition(s) this trial relates to.

systemic sclerosis

As listed by the trial registrant

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

Systemic sclerosis (SSC)

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

  • The Ottawa Hospital

    Ottawa, Ontario, Canada

More trials for these conditions

Other studies related to the condition(s) this trial covers.