NCT01769755

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
14

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Mar 2013

Geographic Reach
1 country

12 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 15, 2013

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 17, 2013

Completed
1 month until next milestone

Study Start

First participant enrolled

March 1, 2013

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2014

Completed
Last Updated

March 1, 2018

Status Verified

August 1, 2015

Enrollment Period

1.7 years

First QC Date

January 15, 2013

Last Update Submit

February 27, 2018

Conditions

Crohns Disease

Keywords

Crohn's diseaseFistulaDiarrheaColonStem cells

Outcome Measures

Primary Outcomes (1)

  • Adverse Events

    Number of participants experiencing adverse events during the initial and extended follow-up periods

    Up to 1 year

Secondary Outcomes (2)

  • Clinical Response

    Up to 1 year

  • Clinical Remission

    Up to 1 year

Study Arms (2)

Human Placenta-Derived Cells PDA001 Intravenous Infusion

EXPERIMENTAL

Intravenous infusion of Human Placenta-Derived Cells PDA001 over the course of 2 hours.

Biological: PDA001

Vehicle controlled placebo

PLACEBO COMPARATOR

Intravenous infusion of Vehicle Controlled Placebo over the course of 2 hours

Drug: Vehicle Controlled Placebo

Interventions

PDA001BIOLOGICAL

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.

Human Placenta-Derived Cells PDA001 Intravenous Infusion
Vehicle Controlled PlaceboDRUG

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.

Vehicle controlled placebo

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.
  • +4 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (12)

Cedars Sinai Medical Center, Inflammatory Bowel Disease Center

Los Angeles, California, 90048, United States

Location

University of Colorado Health Science Center

Denver, Colorado, 80220-3706, United States

Location

University of Florida

Gainesville, Florida, 32610, United States

Location

University of Miami School of Medicine

Miami, Florida, 33136, United States

Location

Rochester General Hospital

Rochester, New York, 14621, United States

Location

University of Cincinnati Medical Center

Cincinnati, Ohio, 45267, United States

Location

Case Western Reserve University Hospitals of Cleveland

Cleveland, Ohio, 44106, United States

Location

Erlanger Baroness Hospital

Chattanooga, Tennessee, 37403, United States

Location

Vanderbilt - Ingram Cancer Center

Nashville, Tennessee, 37232-5505, United States

Location

Baylor College of Medicine

Houston, Texas, 77030, United States

Location

University of Utah

Salt Lake City, Utah, 84132, United States

Location

McGuire Veterans Affairs Medical Center

Richmond, Virginia, 23249, United States

Location

MeSH Terms

Conditions

Crohn DiseaseFistulaDiarrhea

Condition Hierarchy (Ancestors)

Inflammatory Bowel DiseasesGastroenteritisGastrointestinal DiseasesDigestive System DiseasesIntestinal DiseasesPathological Conditions, AnatomicalPathological Conditions, Signs and SymptomsSigns and Symptoms, DigestiveSigns and Symptoms

Study Officials

  • Monica E Luchi, MD

    Celularity Incorporated

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 15, 2013

First Posted

January 17, 2013

Study Start

March 1, 2013

Primary Completion

November 1, 2014

Study Completion

November 1, 2014

Last Updated

March 1, 2018

Record last verified: 2015-08

Locations

US(12)