A Multi-Center Study to Evaluate the Safety and Efficacy of Intravenous Infusion of Human Placenta-Derived Cells (PDA001) for the Treatment of Adults With Moderate-to-Severe Crohn's Disease

Celularity

Status and phase: Completed; Phase 2

Conditions: Crohn's Disease

Treatments: Drug: Vehice Control; Biological: Human Placenta-Derived Cells PDA001 Intravenous Infusion

Study type: Interventional

Funder types: Industry

Identifiers

NCT01155362

CCT-PDA001-002

Details and patient eligibility

About

The primary objective of the study is to estimate the treatment effect of PDA001 (evaluating 3 different PDA001 dosings) versus placebo in subjects with moderate-to-severe Crohn's Disease. The secondary objective of the study is to assess the safety and tolerability of PDA001 versus placebo in the above-mentioned patient population.

Enrollment: 50 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Males and females ages 18-75 years
2. Understand and voluntarily sign an informed consent
3. Able to adhere to the study visit schedule and other protocol requirements
4. Minimum weight of 50 kg
5. 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.
6. Subject must have inflammatory CD 6 months prior to treatment and have confirmation of ongoing disease activity by colonoscopy or (other method) at screening
7. Subject must have a CDAI score > 220 and < 450 as assessed between Visit 1 and Visit 2
8. 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

Exclusion criteria

1. Any significant medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from participating in the study
2. 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:

1. has not undergone a hysterectomy or bilateral oophorectomy
2. 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).

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

---

50 participants in 4 patient groups, including a placebo group

1 unit Human Placenta-Derived Cells PDA001

Experimental group

Description:

1 unit PDA001 in 240 millilters (mL) infused intravenously in one arm on Day 0 and Day 7.

Treatment:

Biological: Human Placenta-Derived Cells PDA001 Intravenous Infusion

4 units Human Placenta-Derived Cells PDA001

Experimental group

Description:

4 units PDA001 in 240 mL infused intravenously in one arm on Day 0 and Day 7.

Treatment:

Biological: Human Placenta-Derived Cells PDA001 Intravenous Infusion

vehicle control

Placebo Comparator group

Description:

4 units placebo in 240 mL infused intravenously in one arm on Day 0 and Day 7.

Treatment:

Drug: Vehice Control

8 units Human Placenta-Derived Cells PDA001

Experimental group

Description:

4 units PDA-001 in 240 mL infused intravenously in each arm on Day 0 and Day 7 or 8 units PDA-001 in 240 mL infused intravenously in one arm on Day 0 and Day 7

Treatment:

Biological: Human Placenta-Derived Cells PDA001 Intravenous Infusion