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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01769755
Other study ID # CCT-PDA001-CD-003
Secondary ID
Status Completed
Phase Phase 1
First received January 15, 2013
Last updated February 27, 2018
Start date March 2013
Est. completion date November 2014

Study information

Verified date August 2015
Source Celularity Incorporated
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


Description:

This is a randomized, double-blind, placebo-controlled, dose-escalation study to study 3 cohorts of subjects with Crohn's Disease including (but not limited to) those with colonic involvement. Each cohort (n = 9) will include PDA001 treated subjects (n = 6) as well as placebo (vehicle control) treated subjects (n = 3). Cohorts will be enrolled sequentially, beginning with the lowest dose cohort (1/4 unit PDA001) and progressing until the maximum tolerated dose of IV PDA001 is determined.


Recruitment information / eligibility

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.

Study Design


Related Conditions & MeSH terms


Intervention

Biological:
PDA001
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.
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.

Locations

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

Sponsors (1)

Lead Sponsor Collaborator
Celularity Incorporated

Country where clinical trial is conducted

United States, 

Outcome

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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