DB-3Q for Crohn's Disease
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial explores a new treatment, DB-3Q, for individuals with Crohn's disease unresponsive to other medications. The goal is to determine if this approach, using a special product derived from bone marrow stem cells, is safe and effective. Participants will receive either the treatment or a placebo (a non-active substance) through an IV. This trial may suit those who have had Crohn's disease for at least six months and have not found relief from advanced immune therapies or can no longer use these treatments. As a Phase 2 trial, the research focuses on measuring the treatment's effectiveness in an initial, smaller group of people.
Do I need to stop my current medications for the trial?
Yes, you may need to stop some medications before joining the trial. For example, monoclonal therapies must be stopped for at least 8 weeks, and certain other medications like cyclosporine and JAK inhibitors must be stopped for at least 4 weeks. Please check with the trial team for specific guidance on your medications.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research shows that the safety of DB-3Q remains under investigation. This treatment uses tiny particles released by cells, derived from bone marrow stem cells. Although specific safety data for DB-3Q is not yet available, the current testing phase involves researchers closely monitoring participants' responses.
In similar studies, researchers carefully monitor participants to ensure safety, tracking and managing any unwanted effects. Since DB-3Q is not yet approved for use, understanding its safety is ongoing. Participants can expect thorough monitoring throughout the trial.12345Why do researchers think this study treatment might be promising?
DB-3Q is unique because it offers a new intravenous approach to treating Crohn's disease, potentially providing a more direct and potent effect. Current treatments often involve oral medications like corticosteroids and immunosuppressants, which can take time to work and may have significant side effects. Researchers are excited about DB-3Q because it targets the condition through different doses (15 mL, 30 mL, 45 mL), which could allow for personalized treatment strategies. This could make DB-3Q more adaptable and effective, potentially offering faster relief for patients compared to traditional therapies.
What evidence suggests that DB-3Q might be an effective treatment for Crohn's disease?
Research has shown that DB-3Q, a treatment derived from special cells in bone marrow, may benefit people with Crohn's disease. One study found that more than half of the patients with Crohn's disease responded positively to DB-3Q. This trial will test different dosages of DB-3Q—15 mL, 30 mL, and 45 mL—to evaluate its effectiveness. The treatment might also aid those with complex anal fistulas caused by Crohn's disease. It uses tiny particles to facilitate cell communication, reducing swelling and supporting healing. Although further research is necessary, early results appear promising for individuals with Crohn's disease unresponsive to other treatments.12367
Are You a Good Fit for This Trial?
This trial is for adults with Crohn's disease that has not improved with standard treatments. Participants should be medically stable and able to follow study procedures. People with certain infections, cancers, or other serious health issues may not qualify.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive DB-3Q or placebo intravenously to evaluate safety and effectiveness
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- DB-3Q
Trial Overview
The study compares a new treatment called DB-3Q—made from bone marrow stem cell-derived extracellular vesicles—to a placebo. The goal is to see if DB-3Q is safe and helps people whose Crohn's disease hasn't responded to usual therapies.
How Is the Trial Designed?
4
Treatment groups
Experimental Treatment
Placebo Group
Find a Clinic Near You
Who Is Running the Clinical Trial?
Direct Biologics, LLC
Lead Sponsor
Citations
DB-3Q bmMSC-EVs in Patients With Perianal Fistulizing ...
This is a double-blind, randomized, placebo-controlled, sequential cohort, ascending dose clinical trial to evaluate the safety and determine ...
DB-3Q for Crohn's Disease
One study found that more than half of the patients with Crohn's disease responded positively to this treatment. For those with complicated anal fistulas, ...
3.
ctv.veeva.com
ctv.veeva.com/study/db-3q-bmmsc-evs-in-patients-with-perianal-fistulizing-crohns-diseaseDB-3Q bmMSC-EVs in Patients With Perianal Fistulizing ...
evaluate the safety and determine the efficacy of ascending doses of DB-3Q for the treatment of Perianal Fistulizing Crohn's Disease.
Systematic review: outcomes and adverse events from ... - PMC
About 92.3% reported clinical efficacy endpoints. reporting reduced between periods (46.4%‐41.1%), creased (16.8%‐30.4%). Clinical response was an outcome in ...
DB-3Q bmMSC-EVs in Patients With Perianal Fistulizing ...
This is a double-blind, randomized, placebo-controlled, sequential cohort, ascending dose clinical trial to evaluate the safety and determine the efficacy ...
Our Clinical Trials
DB-3Q. Perianal Fistulizing Crohn's Disease. Preclinical. Phase 1. Phase 2. Phase 3. DB-3Q. Medically Refractory Crohn's Disease. Preclinical. Phase 1. Phase 2.
7.
mentalhealth.networkofcare.org
mentalhealth.networkofcare.org/Lake/CommunityResources/ClinicalTrials/Detail/NCT06918808?keyword=%22Perianal%20Fistula%20Due%20to%20Crohn%27s%20Disease%22DB-3Q bmMSC-EVs in Patients With Perianal Fistulizing ...
This is a double-blind, randomized, placebo-controlled, sequential cohort, ascending dose clinical trial to evaluate the safety and determine the efficacy ...
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