Crohn Disease (CD)
Donor-Derived Stem Cell Infusions for Adults With Crohn's Disease
This phase 2 study is investigating whether repeated intravenous infusions of donor-derived HB-adMSCs affect Crohn's disease activity and safety outcomes in adults with mild or moderate disease, compared with placebo.
Registry title: HB-adMSCs for the Treatment of Crohn's Disease
1 recruiting U.S. site ↓Study at a glance
- Age
- 18 Years–65 Years
- Treatment
- HB-adMSCs - Hope Biosciences Adipose Derived Mesenchymal Stem Cells or 0.9% sodium chloride
- Design
- Randomized · Quadruple
- Central study contact
- David Gonzalez, RN346-900-0340david@hopebio.org
- Sponsor
- Hope Biosciences Research Foundation
Research question
Do intravenous donor-derived HB-adMSC infusions, compared with placebo, change Crohn's disease activity while meeting the study's safety objectives through week 52?
Participant snapshot
Who the study is looking for
- The study is looking for adults ages 18 through 65.
- Participants must have had a Crohn's disease diagnosis for at least six months, supported by specified medical-record evidence.
- The study seeks people with a screening Crohn's Disease Activity Index (CDAI) score from 150 through 450, described by the registry as mild or moderate disease.
- Participants may be untreated or taking an established Crohn's disease regimen that has remained stable for at least three months before screening.
- The listed recruiting location is in Sugar Land, Texas.
Participation overview
What participation may involve
Participation includes a screening period of up to 35 days, six intravenous administrations during a 16-week treatment period, and safety and efficacy follow-up through 52 weeks after the first treatment. What participation may involve: - Receive either HB-adMSCs or saline placebo by intravenous infusion at weeks 0, 2, 4, 8, 12, and 16. - Complete assessments of Crohn's Disease Activity Index scores from baseline through week 52. - Undergo safety monitoring that includes adverse-event review, laboratory testing, vital signs, weight, and physical examinations. - Provide samples or measurements for fecal calprotectin, C-reactive protein, and erythrocyte sedimentation rate assessments. The registry reports up to 35 days of screening, 16 weeks of treatment, and follow-up through 52 weeks after the first treatment. Infusions are scheduled at six timepoints through week 16, and outcome descriptions identify week 0 as Visit 1 and week 52 as Visit 9; the complete visit-by-visit schedule is not provided.
Study interventions
What participants may receive or do
- HB-adMSCs - Hope Biosciences Adipose Derived Mesenchymal Stem Cells: Participants assigned to this group receive 200 million donor-derived adipose mesenchymal stem cells, within the stated dosing tolerance, by intravenous infusion at weeks 0, 2, 4, 8, 12, and 16.
- 0.9% sodium chloride: Participants assigned to the placebo group receive intravenous 0.9% sodium chloride at weeks 0, 2, 4, 8, 12, and 16.
Study design
How the comparison works
This is a phase 2, parallel-group study comparing HB-adMSC infusions with intravenous saline placebo in an estimated 46 participants, with 23 planned in each arm. Participants are randomly assigned between two parallel groups; the registry plans 23 participants in each group. The registry labels masking as quadruple and lists participants, care providers, investigators, and outcome assessors as masked, while its narrative calls the study double-blinded and says participants and researchers do not know assignments. The comparison group receives intravenous 0.9% sodium chloride on the same reported administration weeks as the HB-adMSC group. The placebo is 0.9% sodium chloride, diluted to the same reported total volume of 270 mL and administered intravenously at weeks 0, 2, 4, 8, 12, and 16.
Reported activities
Procedures and tests
- Intravenous infusions at weeks 0, 2, 4, 8, 12, and 16.
- Crohn's Disease Activity Index assessments.
- Complete blood count, comprehensive metabolic panel, and coagulation testing.
- Vital-sign measurements, including respiratory rate, heart rate, temperature, blood pressure, and oxygen saturation.
- Weight measurement and physical examinations covering multiple body systems.
- Fecal calprotectin testing.
- C-reactive protein and erythrocyte sedimentation rate testing.
- Screening may include review of recent Crohn's disease diagnostic imaging or procedure records and confirmation of specified laboratory and disease-activity criteria.
Eligibility highlights
Details that may affect whether you contact the study
These are selected highlights, not a complete eligibility check. Exact criteria remain in the full registry record below.
Common requirements
- Participants must be 18 through 65 years old.
- Crohn's disease must have been diagnosed at least six months before screening and supported by at least one of the specified forms of medical-record evidence.
- The screening Crohn's Disease Activity Index score must be from 150 through 450.
- Participants may have no established Crohn's treatment or must have used a stable Crohn's therapy dose for at least three months before screening.
- Participants must agree to maintain their established Crohn's treatment, or lack of treatment, throughout the study.
- Screening must show C-reactive protein of at least 1 mg/L and/or an abnormal erythrocyte sedimentation rate above the sex-specific threshold stated by the registry.
- Participants must provide their latest Crohn's diagnostic imaging or procedure records from within three years before screening.
- People who could become pregnant, or whose partners could become pregnant, must follow one of the listed contraceptive measures during participation and for six months after the last study-product administration.
Possible reasons someone may not be able to join
- Specified out-of-range screening results for blood counts, sodium, fasting glucose, potassium, blood urea nitrogen, creatinine, or the blood urea nitrogen-to-creatinine ratio exclude participation.
- A screening Crohn's Disease Activity Index score below 150 or above 450 excludes participation.
- Investigator-determined vital-sign abnormalities at screening exclude participation.
- Specified serious or uncontrolled cardiovascular conditions, including a heart attack within six months before screening, exclude participation.
- Severe chronic obstructive pulmonary disease, pulmonary fibrosis, or pulmonary embolism or deep-vein thrombosis within six months before screening excludes participation.
- Active cancer, or cancer within five years before screening unless curatively treated without recurrence, excludes participation.
- Investigational therapy, or an approved therapy used investigationally, within one year before the first study-product dose excludes participation, except for COVID-19 vaccines.
- Known hepatitis B, hepatitis C, or human immunodeficiency virus infection excludes participation.
- A systemic infection requiring antibiotics, antiviral drugs, or antifungal drugs within 30 days before the first study-product dose excludes participation.
Important unknowns
What the record does not make clear
- The record identifies six infusion weeks and labels week 0 as Visit 1 and week 52 as Visit 9, but it does not provide the complete visit-by-visit schedule or visit length.
- The record states that 23 participants are planned in each treatment arm but does not explicitly state each participant's probability of receiving placebo or whether the allocation ratio can change.
- The eligibility criteria require participants to maintain their established Crohn's treatment, or lack of treatment, but do not list which medications or dose adjustments are permitted.
- The record gives a one-year restriction for investigational therapy but does not provide washout rules for each approved Crohn's medication.
- The record does not state what rescue treatment is permitted if Crohn's disease worsens.
- The criteria require recent diagnostic records and list endoscopy and colonoscopy as examples, but the record does not state whether a new endoscopy or colonoscopy is required by the study.
- The record does not explain which study-related or routine-care costs are covered or billed to insurance.
- The record does not report whether participants are compensated.
- The record does not report reimbursement or support for travel to the Sugar Land site.
- The record does not say whether any follow-up activities can be completed remotely or locally.
- The record does not describe access to HB-adMSCs after study participation ends.
- The Sugar Land location is listed as recruiting, but the record does not show whether every study arm or screening slot is currently available.
Before contacting the site
Questions for the study team
- What is the complete visit schedule, how long are infusion visits, and are any unscheduled monitoring visits expected?
- What is the exact chance of assignment to saline placebo, and when can participants learn their assignment?
- Which current Crohn's medicines may continue, what dose changes are allowed, and are there medication washout periods?
- What happens if Crohn's symptoms worsen, including what rescue treatments are permitted and whether treatment assignment may be revealed?
- Will screening or follow-up require a new endoscopy, colonoscopy, or other imaging, or can recent records be used?
- Which study-related costs are covered, is compensation offered, and is travel assistance available?
- Can any visits or tests be completed remotely or with a local clinician?
- Is the Sugar Land site currently screening, and what is the expected timeline from first contact to randomization?
Before changing care
Questions for your gastroenterologist
- How stable is my Crohn's disease on my current regimen, and what could be the clinical impact of keeping that regimen unchanged during this study?
- What approved treatment alternatives should I understand before considering a placebo-controlled stem-cell study?
- Do my recent Crohn's records, laboratory results, and disease-activity measurements raise concerns that I should discuss with the research team?
- How should you and the research team coordinate if my symptoms worsen or my Crohn's treatment needs to change?
This plain-language digest is provided by the Aidy clinical trials API. It may omit details and is not medical advice or an eligibility decision. Review the full registry record and confirm details with the study team.
Source record
Full registry record
The sections below preserve the study information supplied through ClinicalTrials.gov, including complete descriptions, criteria, outcomes, and locations.
About this study
Methodology: Randomized, double-blind, efficacy and safety study of allogeneic HB-adMSCs vs placebo for the treatment of Crohn's Disease with a 16-week treatment period and a safety and efficacy follow up period for 52 weeks post first treatment. Treatment Duration: 16 weeks General Objectives: To assess the efficacy and safety of multiple intravenous infusions of allogeneic HB-adMSCs by improving signs and symptoms of Crohn's Disease in this subject population. Number of Subjects: 46 (23 in each treatment arm) Indication: Crohn's Disease
Primary Objective: \- To investigate the efficacy of intravenous infusions of allogeneic HB-adMSCs vs placebo in patients with Crohn's Disease as determined by improvements in Crohn's Disease Activity Index (CDAI) scores. (Time Frame: Week 0 to Week 52). Minimal clinically important difference (MCID) for CDAI is defined as a decrease of ≥100 points. Secondary Objectives: * To assess the safety of intravenous infusions of allogeneic HB-adMSCs vs placebo in patients with Crohn's Disease as determined by the incidence of adverse events or serious adverse events. (Time Frame: Week 0 to Week 52). * 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 calprotectin (FC) values. (Time Frame: Week 0 to Week 52). Clinically significant changes in fecal calprotectin (FC) values are defined as a ≥50% reduction in fecal calprotectin concentration from baseline, or a decrease to \<250 µg/g, whichever is achieved first. Exploratory Objectives: * To evaluate the efficacy of intravenous infusions of allogeneic HB-adMSCs vs placebo in patients with Crohn's Disease as determined by improvements in CRP values. (Time Frame: Week 0 to Week 52). * To evaluate the efficacy of intravenous infusions of allogeneic HB-adMSCs vs placebo in patients with Crohn's Disease as determined by improvements in ESR values. (Time Frame: Week 0 to Week 52).
Study design and administration
- Organization
- Hope Biosciences Research Foundation
- Organization class
- Industry
- Organization study ID
- HBCD01
- Lead sponsor
- Hope Biosciences Research Foundation
- Sponsor class
- Industry
- Enrollment type
- Estimated
- Allocation
- Randomized
- Intervention model
- Parallel
- Primary purpose
- Treatment
- Masking
- Quadruple
- Who is masked
- Participant, Care Provider, Investigator, Outcomes Assessor
- Standard age groups
- Adult, Older Adult
Study arms
Experimental
Allogeneic adipose-derived HB-adMSCs
Allogeneic HB-adMSCs (Hope Biosciences adipose derived mesenchymal stem cells), Intravenous
Interventions: Drug: HB-adMSCs - Hope Biosciences Adipose Derived Mesenchymal Stem Cells
Placebo Comparator
0.9% sodium chloride
0.9% sodium chloride, Intravenous
Interventions: Drug: 0.9% sodium chloride
Interventions
Drug
HB-adMSCs - Hope Biosciences Adipose Derived Mesenchymal Stem Cells
Allogeneic HB-adMSCs (Hope Biosciences adipose derived mesenchymal stem cells). Dose: 200 million cells (+/- 20%) suspended in 20mL 0.9% sodium chloride. Route: Intravenous. Regimen: Weeks 0, 2, 4, 8, 12, and 16. Preparation: HB-adMSCs syringe should be diluted in 250 mL 0.9% sodium chloride (for a total volume of 270 mL).
Drug
0.9% sodium chloride
0.9% sodium chloride Dose: N/A - 20mL 0.9% sodium chloride. Route: Intravenous. Regimen: Weeks 0, 2, 4, 8, 12, and 16. Preparation: Placebo syringe should be diluted in 250 mL 0.9% sodium chloride (for a total volume of 270 mL).
Eligibility
18 Years–65 Years
All
Not accepted
Inclusion criteria (21)
- Male and female subjects who are ≥ 18 years old and ≤ 65 years old.Registry-derived · unreviewed
- Must be diagnosed with Crohn's Disease at least 6 months prior to the screening visit, as verified by one or more of the following diagnostic criteria present in the participant's medical records:Registry-derived · unreviewed
- Clinical presentation of symptoms such as diarrhea, abdominal pain, weight loss, fever, and fatigueRegistry-derived · unreviewed
- Radiologic Findings within 3 years of screening date: Imaging studies like CT scans or MRI scans of the abdomen and pelvis that indicate bowel wall thickening, strictures, fistulas, and abscesses characteristic of Crohn's diseaseRegistry-derived · unreviewed
- Histologic Findings within 3 years of screening date: Microscopic examination of tissue biopsies that indicate transmural inflammation with lymphoid infiltratesRegistry-derived · unreviewed
- Exclusion of other conditions: Differential diagnoses, such as ulcerative colitis, infectious enterocolitis, and drug-induced colitis, must be excluded through appropriate evaluationRegistry-derived · unreviewed
- Must have CDAI scores at the screening visit of ≥ 150 to ≤ 450, indicating Mild or Moderate Crohn's Disease.Registry-derived · unreviewed
- Subjects without a current established treatment for Crohn's Disease, or if being treated, subjects who are on a stable dose of Crohn's Disease therapy regimen for ≥3 months prior to screening.Registry-derived · unreviewed
- Subjects must be willing to maintain their established treatment for Crohn's Disease (or lack thereof) for the duration of the study. Subjects must acknowledge that they may be removed from participation in the study for failure to maintain their established treatment for Crohn's Disease (or lack thereof).Registry-derived · unreviewed
- Subjects must have an elevated CRP value at the screening visit of ≥1 mg/L and/or an abnormal ESR value at the screening visit of \> 15 mm/hr. for male subjects or \> 20 mm/hr. for female subjects.Registry-derived · unreviewed
- Subjects must be able to provide the latest (specifically, within 3 years of screening date) diagnostic imaging records for their Crohn's Disease (including but not limited to endoscopy, colonoscopy, MRI scans, ultrasounds, etc.)Registry-derived · unreviewed
- Female study subjects of childbearing potential should not be pregnant or plan to become pregnant during study participation and for 6 months after the last investigational product administration. Female study subjects of childbearing potential must confirm usage of one of the following contraceptive measures:Registry-derived · unreviewed
- Hormonal contraceptives associated with ovulation inhibition (oral, injectable, implantable, patch, or intravaginal).Registry-derived · unreviewed
- Intrauterine device (IUD), or intrauterine hormone-releasing system (IUS).Registry-derived · unreviewed
- Barrier contraceptive methods (condoms, diaphragm, etc.). OR Male subjects if their sexual partners can become pregnant should ensure the use one of the following methods of contraception during study participation and for 6 months after the last administration of the investigated product:.Registry-derived · unreviewed
- <!-- -->Registry-derived · unreviewed
- Hormonal contraceptives associated with ovulation inhibition (oral, injectable, implantable, patch, or intravaginal).Registry-derived · unreviewed
- Intrauterine device (IUD), or intrauterine hormone-releasing system (IUS).Registry-derived · unreviewed
- Barrier contraceptive methods (condoms, diaphragm, etc.).Registry-derived · unreviewed
- Study subjects are able and willing to comply with the requirements of this clinical trial.Registry-derived · unreviewed
- Voluntarily signed informed consent from study subject or legally authorized representative obtained before any clinical-trial related procedures are performed.Registry-derived · unreviewed
Exclusion criteria (35)
- Study subject has any of the following laboratory results at the screening visit:Registry-derived · unreviewed
- WBC: \<3000 cells/μL OR \>15000 cells/μL (\<3 K cells/μL or \>15 K cells/μL)Registry-derived · unreviewed
- Absolute Neutrophil Count: \<1500 cells/μLRegistry-derived · unreviewed
- Sodium: \<120 mEq/L OR \>150 mEq/LRegistry-derived · unreviewed
- Glucose: \>150 mg/dL (for fasting subjects)Registry-derived · unreviewed
- Potassium: \<3.5 mEq/L OR \>6 mEq/LRegistry-derived · unreviewed
- BUN: \>25 mg/dLRegistry-derived · unreviewed
- Creatinine: \>2 mg/dLRegistry-derived · unreviewed
- BUN/Creatinine ratio: \>50Registry-derived · unreviewed
- Study subject has CDAI scores of \< 150 or \> 450 at the screening visit.Registry-derived · unreviewed
- Study participant has any vital sign abnormalities at the screening visit as determined by the investigator.Registry-derived · unreviewed
- Study subject has any of the following cardiovascular issues:Registry-derived · unreviewed
- Severe heart failure (e.g., NYHA Class III/IV)Registry-derived · unreviewed
- Uncontrolled arrhythmiasRegistry-derived · unreviewed
- Recent myocardial infarction (\<6 months from screening visit)Registry-derived · unreviewed
- Uncontrolled hypertensionRegistry-derived · unreviewed
- Study Subject has any of the following pulmonary diseases:Registry-derived · unreviewed
- Severe COPDRegistry-derived · unreviewed
- Pulmonary fibrosisRegistry-derived · unreviewed
- History of recent (\<6 months from screening visit) pulmonary embolism or DVTRegistry-derived · unreviewed
- Study subject has 1 or more significant uncontrolled concurrent medical conditions (verified by medical records), including the following:Registry-derived · unreviewed
- Diabetes MellitusRegistry-derived · unreviewed
- Rheumatoid ArthritisRegistry-derived · unreviewed
- LupusRegistry-derived · unreviewed
- Multiple SclerosisRegistry-derived · unreviewed
- Study subject has any active malignancy, including evidence of cutaneous basal, squamous cell carcinoma or melanoma.Registry-derived · unreviewed
- Study subject has a history of cancer within 5 years of screening visit (unless curatively treated and without recurrence)Registry-derived · unreviewed
- Study subject has known alcoholic addiction or dependency or has current substance use or abuse.Registry-derived · unreviewed
- Receiving any investigational therapy or any approved therapy for investigational use within 1 year prior first dose of the investigational product other than COVID-19 vaccines.Registry-derived · unreviewed
- Study subject has any other laboratory abnormality or medical condition which, in the opinion of the investigator, poses a safety risk or will prevent the subject from completing the study.Registry-derived · unreviewed
- Study subject unable to understand and provide signed informed consent.Registry-derived · unreviewed
- Study subject unlikely to complete the study or adhere to the study procedures.Registry-derived · unreviewed
- Study subject with known concurrent acute or chronic viral hepatis B or C or human immunodeficiency virus (HIV) infection.Registry-derived · unreviewed
- Study subject with any systemic infection requiring treatment with antibiotics, antivirals, or antifungals within 30 days prior to first dose of the investigational product.Registry-derived · unreviewed
- Female subjects who plan to donate eggs or undergo in vitro fertilization treatment during the study within 6 months after the last infusion. OR Male subjects who plan to donate sperm during the study within 6 months after the last infusion.Registry-derived · unreviewed
This information can identify a possible match, conflict, or item needing confirmation. Only the study team can determine eligibility.
Study outcomes
Primary outcome
Changes from Baseline in Crohns Disease Activity Index (CDAI) Scores.
Time frame: Week 0 (Visit 1) to Week 52 (Visit 9)
Changes from Baseline (Week 0) up to Week 52 in Crohn's Disease Activity Index (CDAI) scores. Specifically, clinical response defined as a reduction of at least 100 points in Crohn's Disease Activity Index (CDAI) from baseline. Score ranges from 0 (minimum) - 450 (maximum), the least being asymptomatic and the greatest being most severe.
Secondary outcome
Incidence of serious adverse events (SAEs).
Time frame: Week 0 (Visit 1) to Week 52 (Visit 9)
Incidence of serious adverse events (SAEs).
Secondary outcome
Incidence of treatment-emergent adverse events (TEAEs).
Time frame: Week 0 (Visit 1) to Week 20 (Visit 8)
Incidence of treatment-emergent adverse events (TEAEs). Treatment-emergent adverse events are defined as any adverse events which occur after the first treatment (Week 0) up to the Follow Up Visit (Week 20).
Secondary outcome
Incidence and risk of AEs of particular interest (serious or non serious), including thromboembolic events, infections, and hypersensitivities
Time frame: Week 0 (Visit 1) to Week 52 (Visit 9)
Incidence and risk of AEs of particular interest (serious or non serious), including thromboembolic events, infections, and hypersensitivities.
Secondary outcome
Changes from Baseline in laboratory values results - Complete Blood Count (x10^3 Cells/uL)
Time frame: Week 0 (Visit 1) to Week 52 (Visit 9)
Clinically significant changes from Baseline in laboratory values results - Complete Blood Count (x10\^3 Cells/uL)
Secondary outcome
Changes from Baseline in laboratory values results - Complete Blood Count (% of WBC)
Time frame: Week 0 (Visit 1) to Week 52 (Visit 9)
Clinically significant changes from Baseline in laboratory values results - Complete Blood Count (% of WBC)
Secondary outcome
Changes from Baseline in laboratory values results - Complete Blood Count (pg)
Time frame: Week 0 (Visit 1) to Week 52 (Visit 9)
Clinically significant changes from Baseline in laboratory values results - Complete Blood Count (pg)
Secondary outcome
Changes from Baseline in laboratory values results - Complete Blood Count (g/dL)
Time frame: Week 0 (Visit 1) to Week 52 (Visit 9)
Clinically significant changes from Baseline in laboratory values results - Complete Blood Count (g/dL)
Secondary outcome
Changes from Baseline in laboratory values results - Complete Blood Count (fL)
Time frame: Week 0 (Visit 1) to Week 52 (Visit 9)
Clinically significant changes from Baseline in laboratory values results - Complete Blood Count (fL)
Secondary outcome
Changes from Baseline in laboratory values results - Complete Blood Count (x10^6 Cells/uL)
Time frame: Week 0 (Visit 1) to Week 52 (Visit 9)
Clinically significant changes from Baseline in laboratory values results - Complete Blood Count (x10\^6 Cells/uL)
Secondary outcome
Changes from Baseline in laboratory values results - Complete Blood Count (% Difference in Volume and Size of RBC)
Time frame: Week 0 (Visit 1) to Week 52 (Visit 9)
Clinically significant changes from Baseline in laboratory values results - Complete Blood Count (% Difference in Volume and Size of RBC)
Secondary outcome
Changes from Baseline in laboratory values results - Complete Blood Count (% of Total Blood Cell Count)
Time frame: Week 0 (Visit 1) to Week 52 (Visit 9)
Clinically significant changes from Baseline in laboratory values results - Complete Blood Count (% of Total Blood Cell Count)
Secondary outcome
Changes from Baseline in laboratory values results - Comprehensive Metabolic Panel (g/dL)
Time frame: Week 0 (Visit 1) to Week 52 (Visit 9)
Clinically significant changes from Baseline in laboratory values results - Comprehensive Metabolic Panel (g/dL)
Secondary outcome
Changes from Baseline in laboratory values results - Comprehensive Metabolic Panel (Ratio of Albumin to Calc. Globulin)
Time frame: Week 0 (Visit 1) to Week 52 (Visit 9)
Clinically significant changes from Baseline in laboratory values results - Comprehensive Metabolic Panel (Ratio of Albumin to Calc. Globulin)
Secondary outcome
Changes from Baseline in laboratory values results - Comprehensive Metabolic Panel (U/L)
Time frame: Week 0 (Visit 1) to Week 52 (Visit 9)
Clinically significant changes from Baseline in laboratory values results - Comprehensive Metabolic Panel (U/L)
Secondary outcome
Changes from Baseline in laboratory values results - Comprehensive Metabolic Panel (mg/dL)
Time frame: Week 0 (Visit 1) to Week 52 (Visit 9)
Clinically significant changes from Baseline in laboratory values results - Comprehensive Metabolic Panel (mg/dL)
Secondary outcome
Changes from Baseline in laboratory values results - Comprehensive Metabolic Panel (mEq/L)
Time frame: Week 0 (Visit 1) to Week 52 (Visit 9)
Clinically significant changes from Baseline in laboratory values results - Comprehensive Metabolic Panel (mEq/L)
Secondary outcome
Changes from Baseline in laboratory values results - Comprehensive Metabolic Panel (mL/Min/1.73m^2)
Time frame: Week 0 (Visit 1) to Week 52 (Visit 9)
Clinically significant changes from Baseline in laboratory values results - Comprehensive Metabolic Panel (mL/Min/1.73m\^2)
Secondary outcome
Changes from Baseline in laboratory values results - Comprehensive Metabolic Panel (Ratio of Calc BUN/Creatinine)
Time frame: Week 0 (Visit 1) to Week 52 (Visit 9)
Clinically significant changes from Baseline in laboratory values results - Comprehensive Metabolic Panel (Ratio of Calc BUN/Creatinine)
Secondary outcome
Changes from Baseline in laboratory values results - Coagulation Panel (Seconds)
Time frame: Week 0 (Visit 1) to Week 52 (Visit 9)
Clinically significant changes from Baseline in laboratory values results - Coagulation Panel (Seconds)
Secondary outcome
Changes from Baseline in laboratory values results - Coagulation Panel (Ratio of Prothrombin Time/Mean Prothrombin Time)
Time frame: Week 0 (Visit 1) to Week 52 (Visit 9)
Clinically significant changes from Baseline in laboratory values results - Coagulation Panel (Ratio of Prothrombin Time/Mean Prothrombin Time)
Secondary outcome
Changes from Baseline in Vital Signs - Respiratory Rate (Breaths per minute)
Time frame: Week 0 (Visit 1) to Week 52 (Visit 9)
Clinically significant changes from baseline in Respiratory Rate (Breaths per minute)
Secondary outcome
Changes from Baseline in Vital Signs - Heart Rate (Breaths per minute)
Time frame: Week 0 (Visit 1) to Week 52 (Visit 9)
Clinically significant changes from baseline in Heart Rate (Breaths per minute)
Secondary outcome
Changes from Baseline in Vital Signs - Body Temperature (Celsius)
Time frame: Week 0 (Visit 1) to Week 52 (Visit 9)
Clinically significant changes from baseline in Body Temperature (Celsius)
Secondary outcome
Changes from Baseline in Vital Signs - Systolic Blood Pressure (mmHg)
Time frame: Week 0 (Visit 1) to Week 52 (Visit 9)
Clinically significant changes from baseline in Systolic Blood Pressure (mmHg)
Secondary outcome
Changes from Baseline in Vital Signs - Diastolic Blood Pressure (mmHg
Time frame: Week 0 (Visit 1) to Week 52 (Visit 9)
Clinically significant changes from baseline in Diastolic Blood Pressure (mmHg)
Secondary outcome
Changes from Baseline in Vital Signs - SPO2 (%)
Time frame: Week 0 (Visit 1) to Week 52 (Visit 9)
Clinically significant changes from baseline in SPO2 (%)
Secondary outcome
Clinically significant changes in Weight results (in kg)
Time frame: Week 0 (Visit 1) to Week 52 (Visit 9)
Clinically significant changes in weight (kg)
Secondary outcome
Number of participants with abnormal physical examination results - Abdomen
Time frame: Week 0 (Visit 1) to Week 52 (Visit 9)
Number of participants with abnormal physical examination results - Abdomen
Secondary outcome
Number of participants with abnormal physical examination results - Cardiovascular
Time frame: Week 0 (Visit 1) to Week 52 (Visit 9)
Number of participants with abnormal physical examination results - Cardiovascular
Secondary outcome
Number of participants with abnormal physical examination results - Head, Eyes, Ears, Nose, and Throat
Time frame: Week 0 (Visit 1) to Week 52 (Visit 9)
Number of participants with abnormal physical examination results - Head, Eyes, Ears, Nose, and Throat
Secondary outcome
Number of participants with abnormal physical examination results - Lymph Node
Time frame: Week 0 (Visit 1) to Week 52 (Visit 9)
Number of participants with abnormal physical examination results - Lymph Node
Secondary outcome
Number of participants with abnormal physical examination results - Musculoskeletal
Time frame: Week 0 (Visit 1) to Week 52 (Visit 9)
Number of participants with abnormal physical examination results - Musculoskeletal
Secondary outcome
Number of participants with abnormal physical examination results - Neurological
Time frame: Week 0 (Visit 1) to Week 52 (Visit 9)
Number of participants with abnormal physical examination results - Neurological
Secondary outcome
Number of participants with abnormal physical examination results - Respiratory
Time frame: Week 0 (Visit 1) to Week 52 (Visit 9)
Number of participants with abnormal physical examination results - Respiratory
Secondary outcome
Number of participants with abnormal physical examination results - Skin
Time frame: Week 0 (Visit 1) to Week 52 (Visit 9)
Number of participants with abnormal physical examination results - Skin
Secondary outcome
Change from Baseline in Fecal Calprotectin (FC) values.
Time frame: Week 0 (Visit 1) to Week 52 (Visit 9)
Clinically significant changes in Fecal Calprotectin (FC) values, defined as a ≥50% reduction in fecal calprotectin concentration from baseline, or a decrease to \<250 µg/g, whichever is achieved first.
Recruiting locations in the United States
Hope Biosciences Research Foundation
RecruitingSugar Land, Texas, 77478, United States
David Gonzalez, RN346-900-0340david@hopebio.org
Thanh Cheng, MD
Central study contacts
Registry dates
- First posted
- Jul 22, 2025
- Primary completion
- Dec 2027
- Overall completion
- Dec 2027
Trial information comes from ClinicalTrials.gov and may change. Confirm current status, eligibility, and site details with the study team. Aidy does not provide medical advice or determine eligibility.