PDA001 for the Treatment of Adults With Moderate-to-Severe Crohn's Disease

NCT01155362 | Completed Phase 2 Results DMC FDA Drug

• 1 other identifier: CCT-PDA001-002
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 13

Brief Summary

This Phase 2a study evaluated the efficacy, safety, and tolerability of intravenous human placenta-derived cells (PDA001) compared with placebo in adults with moderate-to-severe Crohn's disease. Three PDA001 dose levels were evaluated.

Conditions

Crohn's Disease

Keywords

Human Placenta-Derived Cells; Crohns disease

Study Arms (4)

200 × 10^6 cells of Human Placenta-Derived Cells PDA001

EXPERIMENTAL

PDA001 administered intravenously at a dose of 1 unit, approximately 200 × 10\^6 cells, on Study Day 0 and Study Day 7.

Biological: Human Placenta-Derived Cells PDA001 Intravenous Infusion

800 × 10^6 cells of Human Placenta-Derived Cells PDA001

EXPERIMENTAL

PDA001 administered intravenously at a dose of 4 units, approximately 800 × 10\^6 cells, on Study Day 0 and Study Day 7.

Biological: Human Placenta-Derived Cells PDA001 Intravenous Infusion

vehicle control

PLACEBO COMPARATOR

Matching placebo administered intravenously on Study Day 0 and Study Day 7.

Drug: Vehicle Control

1.6 × 10^9 cells of Human Placenta-Derived Cells PDA001

EXPERIMENTAL

PDA001 administered intravenously at a dose of 8 units, approximately 1.6 × 10\^9 cells, on Study Day 0 and Study Day 7.

Biological: Human Placenta-Derived Cells PDA001 Intravenous Infusion

Interventions

Human Placenta-Derived Cells PDA001 Intravenous Infusion BIOLOGICAL

1.6 × 10^9 cells of Human Placenta-Derived Cells PDA001; 200 × 10^6 cells of Human Placenta-Derived Cells PDA001; 800 × 10^6 cells of Human Placenta-Derived Cells PDA001

Vehicle Control DRUG

Also known as: Placebo

vehicle control

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Males and females ages 18-75 years
• Understand and voluntarily sign an informed consent
• Able to adhere to the study visit schedule and other protocol requirements
• Minimum weight of 50 kg
• A female of childbearing potential (FCBP)† must have a negative urine pregnancy test at screening (Visit 1) and immediately prior to all doses of IP. In addition, sexually active FCBP must agree to use two of the adequate forms of contraception methods for the duration of the study and the follow-up period. A FCBP must agree to have pregnancy tests at least every 4 weeks during the study. Males (including those who have had a vasectomy) must agree to use barrier contraception (latex condoms) when engaging in reproductive sexual activity with FCBP for the duration of the study and the follow-up period.
• Subject must have inflammatory CD 6 months prior to treatment and have confirmation of ongoing disease activity by colonoscopy or (other method) at screening
• Subject must have a CDAI score \> 220 and \< 450 as assessed between Visit 1 and Visit 2
• The Subject must have failed, i.e., had an inadequate response or lost response (recurrence of symptoms) to an agent, or documented intolerance to an agent at any time

You may not qualify if:

• Any significant medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from participating in the study
• Any condition including the presence of laboratory abnormalities, which places the subject at unacceptable risk if he/she were to participate in the study
• A female of childbearing potential is a sexually mature woman who:
• has not undergone a hysterectomy or bilateral oophorectomy
• has not been naturally postmenopausal for at least 24 consecutive months (i.e., has had menses at any time in the preceding 24 consecutive months).

Sponsors & Collaborators

• Celularity Incorporated: lead
• Celgene Corporation: collaborator

Study Sites (13)

Cedars Sinai Medical Center

Los Angeles, California, 90048, United States

Location

University of California, Irvine

Orange, California, 92868, United States

Location

Yale School of Medicine Digestive Diseases

New Haven, Connecticut, 06510, United States

Location

University of Florida

Gainesville, Florida, 32610, United States

Location

University of Chicago Medical Center

Chicago, Illinois, 60637, United States

Location

Indiana University

Indianapolis, Indiana, 46202-5149, United States

Location

Mt Sinai Hospital

New York, New York, 10029, United States

Location

Rochester General Hospital

Rochester, New York, 14621, United States

Location

Stony Brook University

Stony Brook, New York, 11794-8173, United States

Location

Case Western Reserve University

Cleveland, Ohio, 44106-5066, United States

Location

Vanderbilt University

Nashville, Tennessee, 37212, United States

Location

Baylor College of Medicine

Houston, Texas, 77030, United States

Location

McGuire VA Medical Center

Richmond, Virginia, 23249, United States

Location

Related Publications (1)

• Melmed GY, Pandak WM, Casey K, Abraham B, Valentine J, Schwartz D, Awais D, Bassan I, Lichtiger S, Sands B, Hanauer S, Richards R, Oikonomou I, Parekh N, Targan S, Johnson K, Hariri R, Fischkoff S. Human Placenta-derived Cells (PDA-001) for the Treatment of Moderate-to-severe Crohn's Disease: A Phase 1b/2a Study. Inflamm Bowel Dis. 2015 Aug;21(8):1809-16. doi: 10.1097/MIB.0000000000000441.

  PMID: 25985246 RESULT

Related Links

• PDA-001 for treatment of Crohns disease

MeSH Terms

Conditions

Crohn Disease

Condition Hierarchy (Ancestors)

Inflammatory Bowel Diseases; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases

Study Officials

• sharmila koppisetti, MD

  Celularity Incorporated

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Cohort 2 was conducted as a randomized, double-blind, placebo-controlled study. Participants, care providers, investigators, and outcomes assessors were blinded to treatment assignment. Initial dose-escalation cohorts were conducted open-label.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: The study included sequential cohorts. Initial open-label dose-escalation cohorts evaluated PDA001 1.6 × 10\^9 cells (8 units). A subsequent randomized, double-blind, placebo-controlled cohort evaluated PDA001 200 × 10\^6 cells (1 unit), PDA001 800 × 10\^6 cells (4 units), and placebo in parallel treatment groups.

Study Record Dates

• First Submitted: May 26, 2010
• First Posted: July 1, 2010
• Study Start: August 1, 2010
• Primary Completion: February 1, 2012
• Study Completion: April 1, 2014
• Last Updated: July 7, 2026
• Results First Posted: July 7, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (13)