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
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|ClinicalTrials.gov Identifier: NCT01769755|
Recruitment Status : Completed
First Posted : January 17, 2013
Last Update Posted : March 1, 2018
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|Condition or disease||Intervention/treatment||Phase|
|Crohns Disease||Biological: PDA001 Drug: Vehicle Controlled Placebo||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||14 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|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|
|Study Start Date :||March 2013|
|Actual Primary Completion Date :||November 2014|
|Actual Study Completion Date :||November 2014|
Experimental: Human Placenta-Derived Cells PDA001 Intravenous Infusion
Intravenous infusion of Human Placenta-Derived Cells PDA001 over the course of 2 hours.
Cohort 1 Dose Level 1: ¼ unit Human Placenta-Derived Cells PDA001 infused a total of 5 times 2 weeks apart.
Cohort 2 Dose Level 2: ½ unit Human Placenta-Derived Cells PDA001 infused a total of 5 times 2 weeks apart.
Cohort 3 Dose Level 3: 1 unit Human Placenta-Derived Cells PDA001 infused a total of 5 times 2 weeks apart.
Placebo Comparator: Vehicle controlled placebo
Intravenous infusion of Vehicle Controlled Placebo over the course of 2 hours
Drug: Vehicle Controlled Placebo
Cohort 1 Dose Level 1: ¼ unit vehicle controlled placebo infused a total of 5 times 2 weeks apart.
Cohort 2 Dose Level 2: ½ unit vehicle controlled placebo infused a total of 5 times 2 weeks apart.
Cohort 3 Dose Level 3: 1 unit vehicle controlled placebo infused a total of 5 times 2 weeks apart.
- Adverse Events [ Time Frame: Up to 1 year ]Number of participants experiencing adverse events during the initial and extended follow-up periods
- Clinical Response [ Time Frame: Up to 1 year ]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.
- Clinical Remission [ Time Frame: Up to 1 year ]Clinical remission is defined as a Crohn's Disease Activity Index (CDAI) score CDAI score of ≤ 150 points
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
|Ages Eligible for Study:||18 Years to 75 Years (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
• 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.
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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01769755
|United States, California|
|Cedars Sinai Medical Center, Inflammatory Bowel Disease Center|
|Los Angeles, California, United States, 90048|
|United States, Colorado|
|University of Colorado Health Science Center|
|Denver, Colorado, United States, 80220-3706|
|United States, Florida|
|University of Florida|
|Gainesville, Florida, United States, 32610|
|University of Miami School of Medicine|
|Miami, Florida, United States, 33136|
|United States, New York|
|Rochester General Hospital|
|Rochester, New York, United States, 14621|
|United States, Ohio|
|University of Cincinnati Medical Center|
|Cincinnati, Ohio, United States, 45267|
|Case Western Reserve University Hospitals of Cleveland|
|Cleveland, Ohio, United States, 44106|
|United States, Tennessee|
|Erlanger Baroness Hospital|
|Chattanooga, Tennessee, United States, 37403|
|Vanderbilt - Ingram Cancer Center|
|Nashville, Tennessee, United States, 37232-5505|
|United States, Texas|
|Baylor College of Medicine|
|Houston, Texas, United States, 77030|
|United States, Utah|
|University of Utah|
|Salt Lake City, Utah, United States, 84132|
|United States, Virginia|
|McGuire Veterans Affairs Medical Center|
|Richmond, Virginia, United States, 23249|
|Study Director:||Monica E Luchi, MD||Celularity Incorporated|
|Responsible Party:||Celularity Incorporated|
|Other Study ID Numbers:||
|First Posted:||January 17, 2013 Key Record Dates|
|Last Update Posted:||March 1, 2018|
|Last Verified:||August 2015|
Inflammatory Bowel Diseases
Digestive System Diseases