Is NCT07077746 recruiting in Sugar Land, TX?

Yes, NCT07077746 is currently recruiting participants at its Sugar Land, TX location. This crohn disease (cd) clinical trial is actively enrolling qualified participants.

How do I join the crohn disease (cd) clinical trial in Sugar Land?

To join this clinical trial in Sugar Land, complete the eligibility form on this page. A study coordinator will contact you to discuss next steps and determine if you qualify.

Is participation in this Sugar Land clinical trial free?

Yes, all study-related care is provided at no cost to qualified participants. Many studies also offer compensation for time and travel expenses.

Crohn Disease (CD) Clinical Trial in Sugar Land, TX

About This Crohn Disease (CD) Study in Sugar Land

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

Sponsor: Hope Biosciences Research Foundation

Who Can Participate

Inclusion Criteria

Male and female subjects who are ≥ 18 years old and ≤ 65 years old.

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:

Clinical presentation of symptoms such as diarrhea, abdominal pain, weight loss, fever, and fatigue

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 disease

Histologic Findings within 3 years of screening date: Microscopic examination of tissue biopsies that indicate transmural inflammation with lymphoid infiltrates 4.

Exclusion Criteria

of other conditions: Differential diagnoses, such as ulcerative colitis, infectious enterocolitis, and drug-induced colitis, must be excluded through appropriate evaluation

Must have CDAI scores at the screening visit of ≥ 150 to ≤ 450, indicating Mild or Moderate Crohn's Disease.

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.

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).

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.

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.)

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:

Hormonal contraceptives associated with ovulation inhibition (oral, injectable, implantable, patch, or intravaginal).

Intrauterine device (IUD), or intrauterine hormone-releasing system (IUS).

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:.

Hormonal contraceptives associated with ovulation inhibition (oral, injectable, implantable, patch, or intravaginal).

Intrauterine device (IUD), or intrauterine hormone-releasing system (IUS).

Barrier contraceptive methods (condoms, diaphragm, etc.).

Study subjects are able and willing to comply with the requirements of this clinical trial.

Voluntarily signed informed consent from study subject or legally authorized representative obtained before any clinical-trial related procedures are performed. Exclusion Criteria:

Study subject has any of the following laboratory results at the screening visit:

WBC: \<3000 cells/μL OR \>15000 cells/μL (\<3 K cells/μL or \>15 K cells/μL)

Absolute Neutrophil Count: \<1500 cells/μL

Sodium: \<120 mEq/L OR \>150 mEq/L

Glucose: \>150 mg/dL (for fasting subjects)

Potassium: \<3.5 mEq/L OR \>6 mEq/L

BUN: \>25 mg/dL

Creatinine: \>2 mg/dL

BUN/Creatinine ratio: \>50

Study subject has CDAI scores of \< 150 or \> 450 at the screening visit.

Study participant has any vital sign abnormalities at the screening visit as determined by the investigator.

Study subject has any of the following cardiovascular issues:

Severe heart failure (e.g., NYHA Class III/IV)

Uncontrolled arrhythmias

Recent myocardial infarction (\<6 months from screening visit)

Uncontrolled hypertension

Study Subject has any of the following pulmonary diseases:

Severe COPD

Pulmonary fibrosis

History of recent (\<6 months from screening visit) pulmonary embolism or DVT

Study subject has 1 or more significant uncontrolled concurrent medical conditions (verified by medical records), including the following:

Diabetes Mellitus

Rheumatoid Arthritis

Multiple Sclerosis

Study subject has any active malignancy, including evidence of cutaneous basal, squamous cell carcinoma or melanoma.

Study subject has a history of cancer within 5 years of screening visit (unless curatively treated and without recurrence)

Study subject has known alcoholic addiction or dependency or has current substance use or abuse.

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.

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.

Study subject unable to understand and provide signed informed consent.

Study subject unlikely to complete the study or adhere to the study procedures.

Study subject with known concurrent acute or chronic viral hepatis B or C or human immunodeficiency virus (HIV) infection.

Study subject with any systemic infection requiring treatment with antibiotics, antivirals, or antifungals within 30 days prior to first dose of the investigational product.

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.

Not sure if you qualify? Submit your interest and a study coordinator will help determine your eligibility.

Frequently Asked Questions

Q:Is this study available in Sugar Land?

Yes, this clinical trial (NCT07077746) has an active research site in Sugar Land, TX that is currently enrolling participants.

Q:Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. This study has been reviewed and approved, and participants are closely monitored by medical professionals. You can withdraw at any time.

Q:Will I be compensated?

Many clinical trials offer compensation for your time and travel expenses. Specific compensation details will be discussed during the screening process. All study-related medical care is provided at no cost.

Q:Can I leave the trial if I change my mind?

Absolutely. Participation is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty.

Still have questions? Our study coordinators are here to help.

Crohn Disease (CD) Treatment Options in Sugar Land, TX

If you're searching for crohn disease (cd) treatment options in Sugar Land, TX, this clinical trial (NCT07077746) may be an excellent opportunity. Clinical trials provide access to cutting-edge treatments that aren't yet available to the general public, often at no cost to participants.

Our Sugar Land research site is actively enrolling participants for this clinical trial. You'll receive care from experienced crohn disease (cd) specialists who are at the forefront of medical research. All study-related care, including examinations, treatments, and monitoring, is provided at no cost to qualified participants.

Looking for more options? Browse all crohn disease (cd) clinical trials near you to find additional studies recruiting in your area.

Crohn Disease (CD) Clinical Trial in Sugar Land, TX

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