36 Participants NeededMy employer runs this trial

DB-3Q for Crohn's Disease

BA
Overseen ByBill Arana
Age: 18+
Sex: Any
Trial Phase: Phase 2
Sponsor: Direct Biologics, LLC
Must be taking: Immunomodulators, Corticosteroids
Prior Safety DataThis treatment has passed at least one previous human trial

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.12345

Why 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

Written informed consent from participant
I have had Crohn's disease for over 6 months and did not improve with advanced therapy.
My budesonide dose has not changed for at least 2 weeks.
See 10 more

Exclusion Criteria

PT, aPTT, or INR >1.5 times upper limit of normal at screening
AST or ALT >3 times upper limit of normal at screening
Lack of informed consent
See 27 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive DB-3Q or placebo intravenously to evaluate safety and effectiveness

12 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

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

Group I: DB-3Q 45 mL IVExperimental Treatment1 Intervention
Group II: DB-3Q 30 mL IVExperimental Treatment1 Intervention
Group III: DB-3Q 15 mL IVExperimental Treatment1 Intervention
Group IV: Placebo IVPlacebo Group1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Direct Biologics, LLC

Lead Sponsor

Trials
11
Recruited
1,100+

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, ...

DB-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.

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 ...