Stem Cells for the Treatment of Crohn's Disease

Inclusion:

• Male and female patients who arebetween 18 & 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
• Patients without a current established treatment for Crohn's Disease, or if being treated, patients who are on a stable dose of Crohn's Disease therapy regimen for ≥3 months prior to screening.
• Patients must be willing to maintain their established treatment for Crohn's Disease (or lack thereof) for the duration of the study.
• Patients 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 patients 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 patients 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 patients 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:.
• Study patients are able and willing to comply with the requirements of this clinical trial.
• Voluntarily signed informed consent from study patient or legally authorized representative obtained before any clinical-trial related procedures are performed.

Exclusion:

• Exclusion of other conditions: Differential diagnoses, such as ulcerative colitis, infectious enterocolitis, and drug-induced colitis, must be excluded through appropriate evaluation
• Study participant has any vital sign abnormalities at the screening visit as determined by the investigator.
• Study patient has certain cardiovascular issues
• History of recent (6 months from screening visit) pulmonary embolism or DVT
• Study patient has 1 or more significant uncontrolled concurrent medical conditions (verified by medical records), including the following:
  • Diabetes Mellitus
  • Rheumatoid Arthritis
  • Lupus
  • Multiple Sclerosis
• Study patient has any active malignancy, including evidence of cutaneous basal, squamous cell carcinoma or melanoma.
• Study patient has a history of cancer within 5 years of screening visit (unless curatively treated and without recurrence)
• Study patient 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 patient has any other laboratory abnormality or medical condition which, in the opinion of the investigator, poses a safety risk or will prevent the patient from completing the study.
• Study patient unable to understand and provide signed informed consent.
• Study patient unlikely to complete the study or adhere to the study procedures.
• Study patient with known concurrent acute or chronic viral hepatis B or C or human immunodeficiency virus (HIV) infection.
• Study patient with any systemic infection requiring treatment with antibiotics, antivirals, or antifungals within 30 days prior to first dose of the investigational product.
• Female patients who plan to donate eggs or undergo in vitro fertilization treatment during the study within 6 months after the last infusion. OR Male patients who plan to donate sperm during the study within 6 months after the last infusion.

* Other inclusion/exclusion criteria will be described discussed upon enrollment.