Stem cells tested for a tough Crohn's complication – but trial stopped early

NCT ID NCT04519697

Terminated Disease control Sponsor: Anthony Lembo Source: ClinicalTrials.gov ↗

First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tested whether stem cells from donated bone marrow could safely heal rectovaginal fistulas in women with Crohn's disease. These fistulas are abnormal connections between the rectum and vagina that cause pain, infections, and poor quality of life. The trial planned to enroll 20 women but was terminated early, so we don't have clear results on whether the treatment works.

What this could mean

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

Active substance: allogeneic bone marrow derived mesenchymal stem cells
What this could lead to: If successful, this approach could offer a new way to heal rectovaginal fistulas in Crohn's disease, potentially reducing pain and improving quality of life.
What could go wrong: This was a very early (Phase 1/2) trial with only 20 participants, and it was terminated early, so we have limited data on safety and effectiveness. Stem cell treatments also carry risks like infection or immune reactions.

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

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Conditions

The condition(s) this trial relates to.

Crohn disease Fistula Rectovaginal Fistula

As listed by the trial registrant

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

CROHN DISEASE CROHN DISEASE OF VULVA RECTOLABIAL; FISTULA RECTOVAGINAL FISTULA

Contacts and locations

Locations

Cleveland Clinic

Cleveland, Ohio, 44195, United States

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