TerminatedPhase 1

Study of ExoFlo for the Treatment of Medically Refractory Ulcerative Colitis

Stopped: Enrollment challenges.

United States4 participantsStarted 2022-12-19

Plain-language summary

Protocol Summary * Title: A Phase I study of ExoFlo, an ex vivo culture-expanded adult allogeneic bone marrow mesenchymal stem cell derived extracellular vesicle isolate product, for the treatment of medically refractory ulcerative colitis. * Short Title: ExoFlo for ulcerative colitis * Phase: 1 * Methodology: Open label * Study Duration: 24 months * Subject Participation: 58 weeks * Single or Multi-Site: Multi-Site

Who can participate

Age range18 Years – 75 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. Males and Females 18-75 years of age
✓. Ulcerative colitis of at least 6 months duration with medically refractory symptoms
✓. Failed to have improvement of disease while receiving at least one monoclonal antibody (infliximab, adalimumab, certolizumab, golimumab, vedolizumab, ustekinumab) or tofacitinib for 8 weeks duration prior to enrollment.
✓. Or is intolerant or has a contra-indication to monoclonal antibodies
✓. Exposure to corticosteroids, 5-ASA drugs, thiopurines, methotrexate, anti-TNF therapy, anti-integrin and anti-interleukin in the past are permitted but a washout period of 8 weeks for any monoclonal antibody is necessary.
✓. If receiving conventional immunomodulators (ie, AZA, 6-MP, or MTX), must have been taking them for ≥12 weeks, and be on a stable dose for at least 4 weeks prior to receiving the first dose of the study drug.
✓. If AZA, 6-MP, or MTX has been recently discontinued, it must have been stopped for at least 4 weeks prior to receiving the first dose of the study drug.
✓. If receiving oral 5-ASA compounds, the dose must have been stable for at least 4 weeks prior to receiving the first dose of the study drug.

Exclusion criteria

What they're measuring

Safety of intravenous ExoFlo in subjects with medically refractory ulcerative colitis who have failed, or are intolerant, or have a contraindication to one or more monoclonal antibodies.

Timeframe: 58 Weeks

Feasibility of intravenous ExoFlo in subjects with medically refractory ulcerative colitis who have failed, or are intolerant, or have a contraindication to one or more monoclonal antibodies.

Timeframe: 58 Weeks

Trial details

NCT IDNCT05176366

SponsorDirect Biologics, LLC

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2024-12-01

View on ClinicalTrials.gov More Ulcerative Colitis trials

Plain-language summary

Who can participate

Age range18 Years – 75 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. Males and Females 18-75 years of age
✓. Ulcerative colitis of at least 6 months duration with medically refractory symptoms
✓. Failed to have improvement of disease while receiving at least one monoclonal antibody (infliximab, adalimumab, certolizumab, golimumab, vedolizumab, ustekinumab) or tofacitinib for 8 weeks duration prior to enrollment.
✓. Or is intolerant or has a contra-indication to monoclonal antibodies
✓. Exposure to corticosteroids, 5-ASA drugs, thiopurines, methotrexate, anti-TNF therapy, anti-integrin and anti-interleukin in the past are permitted but a washout period of 8 weeks for any monoclonal antibody is necessary.
✓. If receiving conventional immunomodulators (ie, AZA, 6-MP, or MTX), must have been taking them for ≥12 weeks, and be on a stable dose for at least 4 weeks prior to receiving the first dose of the study drug.
✓. If AZA, 6-MP, or MTX has been recently discontinued, it must have been stopped for at least 4 weeks prior to receiving the first dose of the study drug.
✓. If receiving oral 5-ASA compounds, the dose must have been stable for at least 4 weeks prior to receiving the first dose of the study drug.

Exclusion criteria

What they're measuring

Safety of intravenous ExoFlo in subjects with medically refractory ulcerative colitis who have failed, or are intolerant, or have a contraindication to one or more monoclonal antibodies.

Timeframe: 58 Weeks

Feasibility of intravenous ExoFlo in subjects with medically refractory ulcerative colitis who have failed, or are intolerant, or have a contraindication to one or more monoclonal antibodies.

Timeframe: 58 Weeks