Crohns Disease Clinical Trial
Official title:
A Randomized, Double-Blind, Placebo-Controlled Dose Escalation Study to Determine the Safety and Efficacy of Intravenous Infusion of Human Placenta-Derived Cells (PDA001) for the Treatment of Crohn's Disease
Verified date | August 2015 |
Source | Celularity Incorporated |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
To assess the safety and efficacy of intravenous (IV) PDA001 infused every two weeks for up to 5 total infusions in subjects with Crohn's disease who are refractory to one or more standard Crohn's disease therapies.
Status | Completed |
Enrollment | 14 |
Est. completion date | November 2014 |
Est. primary completion date | November 2014 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 75 Years |
Eligibility |
Inclusion Criteria: - • Males and females 18 - 75 years of age at the time of signing the informed consent document. - Minimum weight of subject is 40 kg at screening. - Subject must have inflammatory Crohn's Disease (CD) diagnosed at least 6 months but no greater than 15 years prior to treatment with Investigational Product (IP). - Subject must have confirmation of ongoing CD by ileocolonoscopy at screening. - Subject must have a Crohn's Disease Activity Index (CDAI) score = 220 and = 450 as assessed between Visit 1 and Visit 2. Exclusion Criteria: - Subject has any significant medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from participating in the study including but not limited to - Liver Function Tests Aspartate aminotransferase (AST) or Alanine aminotransferase (ALT) > 2.5 x the upper limit of normal at screening. - Serum creatinine concentration > 2.0 mg/dl at screening. Alkaline phosphatase > 2.5 x the upper limit of normal at screening. - Bilirubin level > 2 mg/dL (unless subject has known Gilbert's disease). - Pregnant or lactating females. - Morbidly obese subjects Body Mass Index (BMI) > 35 at screening). - Subject has untreated chronic infection including Clostridium difficile toxin positive at screening or treatment of any infection with antibiotics within 4 weeks prior to dosing with IP (other than a treated urinary tract infection or drained perianal abscess). Note: Stable doses of antibiotics used to treat Crohn's Disease are allowed. - Subject has organic heart disease (eg, congestive heart failure), clinically significant arrhythmia or clinically significant abnormal findings on Electrocardiograms (ECG). - Subject has a history of other malignancies within 5 years (except basal cell carcinoma of the skin that is surgically cured, remote history of cancer now considered cured or positive Pap smear with subsequent negative follow up). - Subject has had a stricture of the bowel requiring hospitalization within 182 days prior to treatment with IP. - Subject has had bowel surgery other than perianal (for example, fistulotomy, seton placement, or abscess drainage) or previous abscess drainage within 182 days prior to treatment with IP. - Subject has had any surgery within 28 days prior to treatment with IP. - Subject has a colostomy, ileostomy or ileal pouch anal anastomosis. - Subject has received an investigational agent —an agent or device not approved by FDA for marketed use in any indication—within 90 days (or 5 half-lives, whichever is longer) prior to treatment with investigational product. - Subject has received previous cell therapy. - Subject is expecting to have elective surgery at any time between Visit 1 (screening) and Visit 7 (end of induction phase). - Subject has concurrent diagnosis of ulcerative colitis. - Subjects with protein C or S deficiency. - Subjects with prior history of thrombophlebitis or other pathological arterial or venous thrombosis. |
Country | Name | City | State |
---|---|---|---|
United States | Erlanger Baroness Hospital | Chattanooga | Tennessee |
United States | University of Cincinnati Medical Center | Cincinnati | Ohio |
United States | Case Western Reserve University Hospitals of Cleveland | Cleveland | Ohio |
United States | University of Colorado Health Science Center | Denver | Colorado |
United States | University of Florida | Gainesville | Florida |
United States | Baylor College of Medicine | Houston | Texas |
United States | Cedars Sinai Medical Center, Inflammatory Bowel Disease Center | Los Angeles | California |
United States | University of Miami School of Medicine | Miami | Florida |
United States | Vanderbilt - Ingram Cancer Center | Nashville | Tennessee |
United States | McGuire Veterans Affairs Medical Center | Richmond | Virginia |
United States | Rochester General Hospital | Rochester | New York |
United States | University of Utah | Salt Lake City | Utah |
Lead Sponsor | Collaborator |
---|---|
Celularity Incorporated |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Adverse Events | Number of participants experiencing adverse events during the initial and extended follow-up periods | Up to 1 year | |
Secondary | Clinical Response | A clinical response is defined as a reduction from baseline by 25% and/or = 100 points in the Crohn's Disease Activity Index (CDAI) score. The Crohn's Disease Activity Index or CDAI is a research tool used to quantify the symptoms of patients with Crohn's disease. | Up to 1 year | |
Secondary | Clinical Remission | Clinical remission is defined as a Crohn's Disease Activity Index (CDAI) score CDAI score of = 150 points | Up to 1 year |
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