HB-adMSCs for Crohn's Disease

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Hope Biosciences

Disqualifiers: Diabetes, Heart failure, Cancer, others

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 20

Duration: 16 weeks

46 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment called HB-adMSCs, a type of cell therapy, to determine its effectiveness for people with Crohn's Disease symptoms, such as diarrhea and abdominal pain. Participants will receive either the active treatment or a placebo through IV infusions over 16 weeks. The trial aims to assess the safety and effectiveness of this treatment in improving symptoms. Individuals who have had Crohn's Disease for at least six months and experience symptoms like frequent diarrhea or abdominal pain may be suitable for this study. As a Phase 2 trial, this research focuses on evaluating the treatment's effectiveness in an initial, smaller group, offering participants a chance to contribute to important medical advancements.

Will I have to stop taking my current medications?

The trial requires that you stay on your current Crohn's Disease treatment if you have one, and you must maintain it throughout the study.

Is there any evidence suggesting that this treatment is likely to be safe for humans?

Research has shown that HB-adMSCs, stem cells derived from fat tissue, have been studied for safety in various conditions. One study found these cells safe when administered intravenously as a single dose, with no serious side effects reported. Another study is investigating how these stem cells might reduce inflammation and improve the quality of life for individuals with Crohn's Disease.

Overall, evidence suggests that HB-adMSCs are well-tolerated in humans. Most participants in these studies did not experience serious side effects. These findings are promising, especially for those considering joining a trial involving these treatments. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for Crohn's Disease?

Researchers are excited about HB-adMSCs for Crohn's Disease because this treatment uses allogeneic adipose-derived mesenchymal stem cells, which offer a novel way to potentially heal the gut. Unlike standard treatments that primarily focus on reducing inflammation with medications like corticosteroids or immunosuppressants, HB-adMSCs aim to promote tissue repair and modulate the immune response. Delivered intravenously, these stem cells can home in on areas of inflammation, offering a targeted approach that could lead to improved outcomes for patients.

What evidence suggests that HB-adMSCs might be an effective treatment for Crohn's Disease?

Research has shown that HB-adMSCs, stem cells from human fat tissue, might help treat Crohn's Disease. In this trial, participants will receive either the experimental treatment of allogeneic adipose-derived HB-adMSCs or a placebo comparator of 0.9% sodium chloride. Other studies have found these stem cells effective in improving health in conditions like Rheumatoid Arthritis by reducing inflammation. These cells may repair and calm the overactive immune response seen in Crohn's Disease. While specific data for Crohn's is still being collected, early results in similar conditions are promising. This suggests that HB-adMSCs could help manage symptoms and improve the quality of life for those with Crohn's. ^{1 2 4 6 7}

Who Is on the Research Team?

Thanh Cheng, MD

Principal Investigator

Hope Biosciences Research Foundation

Are You a Good Fit for This Trial?

This trial is for individuals with Crohn's Disease who are eligible to receive stem cell therapy. The study will include 46 participants, split into two groups. Specific eligibility details aren't provided, but typically participants must meet certain health criteria and not have conditions that could interfere with the treatment or skew results.

Inclusion Criteria

Having an elevated CRP value at the screening visit of ≥1 mg/L and/or an abnormal ESR value at the screening visit

My Crohn's Disease is mild or moderate based on my CDAI score.

I am between 18 and 65 years old.

Exclusion Criteria

I have a specific lung condition.

I will not donate sperm during the study or for 6 months after.

CDAI scores of < 150 or > 450 at the screening visit

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive multiple intravenous infusions of allogeneic HB-adMSCs or placebo for the treatment of Crohn's Disease

16 weeks

Regular visits as per protocol

Follow-up

Participants are monitored for safety and effectiveness after treatment

52 weeks

Visits at Week 20 and Week 52

What Are the Treatments Tested in This Trial?

Interventions

• HB-adMSCs

Trial Overview The trial is testing the safety and effectiveness of HB-adMSCs (stem cells derived from human fat tissue) compared to a placebo (0.9% sodium chloride solution). Participants will be randomly assigned to either the stem cell group or placebo group, without knowing which one they're in.

How Is the Trial Designed?

Group I: Allogeneic adipose-derived HB-adMSCs Experimental Treatment 1 Intervention

Allogeneic HB-adMSCs (Hope Biosciences adipose derived mesenchymal stem cells), Intravenous

Group II: 0.9% sodium chloride Placebo Group 1 Intervention

0.9% sodium chloride, Intravenous

Who Is Running the Clinical Trial?

Hope Biosciences

Lead Sponsor

Trials

27

Recruited

470+

Hope Biosciences Research Foundation

Lead Sponsor

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT07077746

HB-adMSCs for the Treatment of Crohn's Disease To evaluate the efficacy of intravenous infusions of allogeneic HB-adMSCs vs placebo in patients with Crohn's Disease as determined by improvements in fecal ...

2. hope.bio hope.bio/post/tbi-research-update

Open for Hope! A Spring 2024 TBI Research Update Hope Biosciences banks, cultures, and supports FDA-authorized studies using mesenchymal stem cells (MSCs) · taken from adipose (fat) tissue and ...

3. withpower.com withpower.com/trial/phase-2-crohn-disease-8-2025-ba2ce

HB-adMSCs for Crohn's Disease Trial Overview The trial is testing the safety and effectiveness of HB-adMSCs (stem cells derived from human fat tissue) compared to a placebo (0.9% sodium ...

4. hope.bio hope.bio/post/fda-approval-to-commence-first-stem-cell-clinical-trial-for-protection-against-covid-19

Stem Cell FDA approved trial In a recent Phase I/II clinical trial for Rheumatoid Arthritis, results appeared to show that HB-adMSCs were safe and effective in attenuating ...

5. hopebio.org hopebio.org/artifact?id=a1TRi000000QCLhMAO

Hope Biosciences Research Foundation The trial successfully met its primary endpoint, demonstrating statistically significant improvements in both physical and mental health for the treatment ...

6. finance.yahoo.com finance.yahoo.com/news/hope-biosciences-research-foundation-opens-120000221.html

Hope Biosciences Research Foundation Opens Enrollment ... Phase II study to evaluate the potential of HB-adMSCs in reducing inflammation and improving quality of life for adults living with Crohn's ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8896321/

Safety and efficacy of autologous, adipose-derived ... The results indicated that a single, intravenous administration of autologous adMSCs is safe and efficacious for improvement in joint function in patients with ...