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Study of Human Placenta-derived Cells (PDA001) to Evaluate the Safety and Effectiveness for Patients With Active Rheumatoid Arthritis

Primary Purpose

Rheumatoid Arthritis

Status

Terminated

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

PDA001

Vehicle Controlled Placebo

About this trial

This is an interventional treatment trial for Rheumatoid Arthritis focused on measuring Human Placenta-Derived Cells

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Subjects must satisfy the following criteria to be enrolled in the study:

Diagnosis of RA as defined by the 1987-revised ACR criteria.
RA, characterized by at least 6 out of 66 swollen joints and 6 out of 68 tender joints at Screening and Baseline, and at least 2 of the following: a C reactive protein level (CRP), greater than the upper limit of normal (ULN) ³ 1 mg/dl, an erythrocyte sedimentation rate (ESR) of at least 28 mm per hour, or morning stiffness lasting longer than 45 minutes.
Non responsive or intolerant to a minimum of 2 RA therapies which are classified as DMARDs, biologics, or corticosteroids.
Biological medication must be discontinued 30 day prior to the first dose of study drug, except golimumab and actemra which are 60 days, and infliximab, alefacept and efalizumab, which must have been discontinued 90 days prior to the first dose of IP.
Cytotoxic agents, including but not limited to chlorambucil, cyclophosphamide, nitrogen mustard, or other alkylating agents must have been discontinued 90 days prior to the first dose of IP.
Subjects must be able to tolerate intravenous infusions in both arms.
There should be no change in RA medication dose anticipated during the initial treatment and re treatment periods and the respective 12 week follow-up period for each dosing treatment period. The following rules apply for anti-rheumatic medications taken during the study:
DMARDs must have must have been stable for least 90 days prior to dosing with IP.
Low -dose corticosteroids are permitted (prednisolone ≤ 10 mg per day or equivalent). Corticosteroids must have been stable for at least 30 days prior to dosing with IP.
DMARDs and corticosteroids must remain stable throughout the initial 3 months of study and throughout subsequent treatment periods

The presence of any of the following will exclude a subject from enrollment:

Prior use of rituximab and other B-cell depleting therapies, abatacept, prior use of more than 2 biologic therapies.
Subject has received an investigational agent in any indication-within 60 days (or 5 half-lives, whichever is longer) prior to treatment with IP.
Subject has received previous cell therapy.
Serum creatinine concentration > 2.0 mg/dl at screening.
Alkaline phosphatase > 2.5x the upper limit of normal at screening.
Bilirubin level > 1.5 mg/dL (unless subject has known Gilbert's disease).
Untreated chronic infection or treatment of any infection with antibiotics within 4 weeks prior to dosing with IP.
Positive HIV test at Screening. Positive Hepatitis B surface antigen at Screening. Positive Hepatitis C antibody at Screening.
Organic heart disease (e.g., congestive heart failure), myocardial infarction within six (6) months prior to screening or clinically significant findings on ECG at screening. Clinically significant arrhythmia.
Primary or secondary immunodeficiency.

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Placebo Comparator

Arm Label

Group 1

Group 2

Vehicle control

Arm Description

1 Unit of PDA001 or 4 units Vehicle Control intravenous on Day 0 and Day 7

4 Units PDA001 or 4 units Vehicle Control intravenous (Placebo) on Day 0 and Day 7

Placebo - Vehicle Control Arm

Outcomes

Primary Outcome Measures

Number/Percentage of Participants With an American College of Rheumatology 20% (ACR20) Response within 12 weeks following the initial dose of study drug

A participant is a responder if the following 3 criteria for improvement from Baseline were met: • ≥ 20% improvement in 68 tender joint count; • ≥ 20% improvement in 66 swollen joint count; and • ≥ 20% improvement in at least 3 of the 5 following parameters: o Patient's assessment of pain (measured on a 100 mm visual analog scale [VAS]) o Patient's global assessment of disease activity (measured on a 100 mm VAS) o Physician's global assessment of disease activity (measured on a 100 mm VAS) o Patient's self-assessment of physical function (Health Assessment Questionnaire - Disability Index (HAQ-DI)) o C-Reactive Protein

Secondary Outcome Measures

Number/Percentage of Participants With an American College of Rheumatology 20% (ACR20) Response at 6 months

Number/percent of subjects achieving an ACR 20 clinical response at each scheduled visit during the first 12 months following the first infusion of study drug.

A participant is an ACR 20 responder if the following 3 criteria for improvement from Baseline were met: • ≥ 20% improvement in 68 tender joint count; • ≥ 20% improvement in 66 swollen joint count; and • ≥ 20% improvement in at least 3 of the 5 following parameters: o Patient's assessment of pain (measured on a 100 mm visual analog scale [VAS]) o Patient's global assessment of disease activity (measured on a 100 mm VAS) o Physician's global assessment of disease activity (measured on a 100 mm VAS) o Patient's self-assessment of physical function (Health Assessment Questionnaire - Disability Index (HAQ-DI)) o C-Reactive Protein

Number/percent of subjects achieving an ACR 50 clinical response at each scheduled visit during the first 12 months following the first infusion of study drug.

A participant is an ACR responder if the following 3 criteria for improvement from Baseline were met: • ≥ 50% improvement in 68 tender joint count; • ≥ 50% improvement in 66 swollen joint count; and • ≥ 50% improvement in at least 3 of the 5 following parameters: o Patient's assessment of pain (measured on a 100 mm visual analog scale [VAS]) o Patient's global assessment of disease activity (measured on a 100 mm VAS) o Physician's global assessment of disease activity (measured on a 100 mm VAS) o Patient's self-assessment of physical function (Health Assessment Questionnaire - Disability Index (HAQ-DI)) o C-Reactive Protein

Number/percent of subjects achieving an ACR 70 clinical response at each scheduled visit during the first 12 months following the first infusion of study drug.

A participant is an ACR 70 responder if the following 3 criteria for improvement from Baseline were met: • ≥ 70% improvement in 68 tender joint count; • ≥ 70% improvement in 66 swollen joint count; and • ≥ 70% improvement in at least 3 of the 5 following parameters: o Patient's assessment of pain (measured on a 100 mm visual analog scale [VAS]) o Patient's global assessment of disease activity (measured on a 100 mm VAS) o Physician's global assessment of disease activity (measured on a 100 mm VAS) o Patient's self-assessment of physical function (Health Assessment Questionnaire - Disability Index (HAQ-DI)) o C-Reactive Protein

Number/percent of subjects achieving a clinical response based on their Clinical Disease Activity Index (CDAI) at each scheduled visit during the first 12 months following the first infusion of study drug.

A subject is considered a responder based on the Clinical Disease Activity Index (CDAI): A composite index where CDAI = SJC+TJC+SGA+PGA. SJC and TJC are the numbers of swollen and tender joints based on 28-joint counts; SGA and PGA represent the subject's and physician's global assessment of disease activity. The CDAI score ranges from 0-76. Clinical disease activity is defined according to CDAI scores where Remission is ≤ 2.8, Low Disease Activity > 2.8 and ≤ 10, Moderate Disease Activity > 10 and ≤ 22, and High Disease Activity > 22

Number/percent of subjects achieving a clinical response based on their Disease Activity Score (DAS 28) score at each scheduled visit during the first 12 months following the first infusion of study drug

A subject is considered a responder based on Disease Activity Score 28 (DAS 28): A measure of severity of disease derived from the following: 28 tender joint count (TJC28); 28 swollen joint count (SJC28), which do not include the distal interphalangeal (DIP) joints, the hip joint, or the joints below the knee, CRP, and SGA. A DAS 28 score > 5.1 indicates high disease activity, a DAS28 score < 3.2 indicates low disease activity, and a DAS28 score < 2.6 indicates clinical remission

Number/Percent of Participants Who Achieve the European League Against Rheumatism (EULAR) Response Criteria Using CRP at Month 12

A subject is considered a responder based on EULAR response: The EULAR response criteria classify each subject as a good, moderate or non-responder to treatment based on the degree of improvement from baseline and the level of disease activity at the endpoint. EULAR response is derived using the individual subject's DAS28 as the measure of severity of disease. Good or moderate response is defined as follows: Good response: DAS28 at the time point ≤ 3.2 and improvement from baseline > 1.2 Moderate response: DAS28 at the time point > 3.2 and improvement from baseline > 1.2, or DAS28 at the time point ≤ 5.1 and improvement from baseline > 0.6 and ≤ 1.2

The change from baseline in the ACR core components. ACR Core Component #1: Percentage Change From Baseline in the Swollen Joint Count at each scheduled visit.

Joint tenderness is the presence of pain in a joint when pressure is applied by the examiner to elicit tenderness. The 68 tender joint count evaluates the following joints: upper-temporomandibular, sternoclavicular, acromioclavicular, shoulder, elbow, wrist, meta-carpophalangeal, proximal interphalangeal and distal interphalangeal; lower: hip, knee, ankle, midtarsal, metatarsophalangeal and proximal interphalangeal.

ACR Core Component #2: Percentage Change From Baseline in the Swollen Joint Count at each scheduled visit through Month 12 following the initial infusion of study drug

Joint swelling is soft tissue swelling that is detectable along the joint margins and is assessed by inspection and direct palpation of the joint, by the examiner. The ACR 66 swollen joint count evaluates the following joints: upper-temporomandibular, sternoclavicular, acromioclavicular, shoulder, elbow, wrist, metacarpophalangeal, proximal interphalangeal and distal interphalangeal; lower: knee, ankle, midtarsal, metatarsophalangeal and proximal interphalangeal.

ACR Core Component #3 Percentage Change From Baseline in the Subject Assessment of Pain at each scheduled visit through Month 12 following the initial dose of study drug

The Subject Assessment of Pain was measured asking the participant to place a vertical line on a 100-mm visual analog scale on which the left-hand boundary (score = 0 mm) represents "no pain," and the right-hand boundary (score = 100 mm) represents "pain as severe as can be imagined." The distance from the mark to the left-hand boundary was recorded in millimeters.

ACR component #4 Percentage Change From Baseline in the Subject Global Assessment of Disease Activity at each scheduled visit through Month 12 following the initial dose of study drug

The Subject Global Assessment of Disease Activity was measured asking the participant to place a vertical line on a 100-mm visual analog scale on which the left-hand boundary (score = 0 mm) represents " lowest disease activity," and the right-hand boundary (score = 100 mm) represents " highest disease activity." The distance from the mark to the left-hand boundary was recorded in millimeters.

ACR Component #5 Percentage Change From Baseline in the Physician Global Assessment of Disease Activity at each scheduled visit through Month 12 following the initial dose of study drug

The Physician Global Assessment of Disease Activity was measured asking the physician to assess the subject's current arthritis disease activity by placing a vertical line on a 100-mm visual analog scale on which the left-hand boundary (score = 0 mm) represents " lowest disease activity," and the right-hand boundary (score = 100 mm) represents " highest disease activity." The distance from the mark to the left-hand boundary was recorded in millimeters

ACR Component #6; Percentage Change From Baseline in the Health Assessment Questionnaire-Disability Index (HAQ-DI) Score at each scheduled visit through Month 12 following the initial dose of study drug

The Health Assessment Questionnaire - Disability Index (HAQ-DI) was a patient-reported questionnaire consisting of 20 questions referring to eight domains: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and usual activities. Participants assessed their ability to do each task over the past week using the following response categories: without any difficulty (0); with some difficulty (1); with much difficulty (2); and unable to do (3). Scores on each task are summed and averaged to provide an overall score ranging from 0 to 3, where zero represents no disability and three very severe, high-dependency disability. Negative mean changes from baseline in the overall score indicate improvement in functional ability.

ACR Component#7 Percentage Change From Baseline in the High Sensitivity C-Reactive Protein (CRP) at each scheduled visit through Month 12 following the initial dose of study drug

C-Reactive Protein (CRP) is a substance produced by the liver that increases in the presence of inflammation in the body. An elevated CRP level is identified with blood tests and is considered a non-specific "marker" for disease

ACR Component #8 Percentage Change From Baseline in Erythrocyte Sedimentation Rate (ESR) at each scheduled visit through Month 12 following the initial dose of study drug

The erythrocyte sedimentation rate (ESR) is a blood test that can reveal inflammatory activity. The subject's blood is placed in a tall, thin tube, red erythrocytes gradually settle to the bottom. Inflammation can cause the cells to clump together. Because these clumps of cells are denser than individual cells, they settle to the bottom more quickly. The ESR test measures the distance red blood cells fall in a test tube in one hour. The farther the red blood cells have descended, the greater the inflammatory response

Change from baseline in rheumatoid factors at each scheduled visit through Month 12 following the initial dose of study drug

Rheumatoid factor is an antibody that is measurable in the blood. Rheumatoid factor is actually an antibody that can bind to other antibodies. High levels of rheumatoid factor can indicate a tendency toward more aggressive disease and/or a tendency to develop rheumatoid nodules and rheumatoid lung disease.

Time to flare of Rheumatoid Arthritis (RA) symptoms

A flare is defined as a 20% increase in both tender and swollen joint counts, an increase in Physician Global Assessment of Disease ≥ 20 mm and an increase in at least 1 of 2 criteria (Patient Global Assessment of Disease ≥ 20 mm, Patient Assessment of Pain ≥ 20 mm) when compared with corresponding values from the subject's best response. Best response is determined by the subject's lowest CDAI score

Changes in inflammatory markers including C-reactive protein (CRP), erythrocyte sedimentation rate (ESR), serum amyloid A (SAA), and IL-6

Inflammatory markers are certain laboratory tests performed using the subjects' serum that indicate the presence of RA. Changes in these test results may indicate an improvement in RA

Change From Baseline in the Disease Activity Score 28 (DAS 28) Using CRP

The DAS28 measures the severity of disease at a specific time and is derived from the following variables: • 28 tender joint count (TJC28) • 28 swollen joint count (SJC28), which do not include the distal interphalangeal (DIP) joints, the hip joint, or the joints below the knee; • C-reactive protein (CRP) • Subject's global assessment of disease activity (SGA). A DAS28 score higher than 5.1 indicates high disease activity, a DAS28 score less than 3.2 indicates low disease activity, and a DAS28 score less than 2.6 indicates clinical remission. Remission: ≤ 2.8; Low Disease Activity: > 2.8 and ≤ 10; Moderate Disease Activity: > 10 and ≤ 22; High Disease Activity: > 22

Change From Baseline in the Clinical Disease Activity Index (CDAI) at Month 3

Clinical Disease Activity Index (CDAI): A simplified composite index as defined by: CDAI = SJC + TJC + SGA + PGA) • SJC and TJC are the numbers of swollen and tender joints based on 28-joint counts. • SGA and PGA represent the subject's and physician's global assessment of disease activity. o The CDAI score ranges from 0-76. Clinical disease activity is categorized according to CDAI scores where Remission ≤ 2.8, Low Disease Activity > 2.8 and ≤ 10, Moderate Disease Activity > 10 and ≤ 22, and High Disease Activity > 22

Change From Baseline in the Clinical Disease Activity Index (CDAI) at Month 6

Full Information

NCT ID

NCT01261403

First Posted

December 15, 2010

Last Updated

July 20, 2020

Sponsor

Celularity Incorporated

Collaborators

Celgene Corporation

1. Study Identification

Unique Protocol Identification Number

NCT01261403

Brief Title

Study of Human Placenta-derived Cells (PDA001) to Evaluate the Safety and Effectiveness for Patients With Active Rheumatoid Arthritis

Official Title

A Phase 2, Randomized, Double- Blind, Placebo-controlled, Multi-center Study to Evaluate the Safety and Efficacy of Intravenous Infusion of Human Placenta-Derived Cells (PDA001) for the Treatment of Adults With Active Rheumatoid Arthritis

Study Type

Interventional

2. Study Status

Record Verification Date

July 2014

Overall Recruitment Status

Terminated

Why Stopped

Enrollment terminated pending additional Phase 1 data

Study Start Date

December 2010 (undefined)

Primary Completion Date

February 2012 (Actual)

Study Completion Date

September 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Celularity Incorporated

Collaborators

Celgene Corporation

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

The primary objective of the study is to assess the safety and efficacy of 2 dose groups (PDA001 versus vehicle control) in subjects with active rheumatoid Arthritis. The secondary objectives of the study are to determine the clinical response at defined visit intervals, determine the time to flare of RA symptoms and to quantify changes in inflammatory markers including C-reactive protein (CRP), erythrocyte sedimentation rate (ESR), serum amyloid A (SAA), and IL-6.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Rheumatoid Arthritis

Keywords

Human Placenta-Derived Cells

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

26 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Group 1

Arm Type

Experimental

Arm Description

1 Unit of PDA001 or 4 units Vehicle Control intravenous on Day 0 and Day 7

Arm Title

Group 2

Arm Type

Experimental

Arm Description

4 Units PDA001 or 4 units Vehicle Control intravenous (Placebo) on Day 0 and Day 7

Arm Title

Vehicle control

Arm Type

Placebo Comparator

Arm Description

Placebo - Vehicle Control Arm

Intervention Type

Biological

Intervention Name(s)

PDA001

Intervention Description

Dose escalation study: Subjects will be assigned to 1 of 2 treatment groups (1 unit or 4 units vs. vehicle control) based on the order in which they enroll in the study. Intravenous infusion will be administered on days 0 and 7. Nonresponders will be unblinded after 12 weeks of study. Non- responders on vehicle control will be re-dosed with the active PDA001 dose assigned at baseline (2 infusions, 7 days apart). Nonresponders taking active PDA001 will enter the safety follow-up portion of the study. Responders at 12 weeks will continue in the safety and efficacy follow-up portion of the study until 12 months of study. Responders will be treated for RA flare between 3-9 months of study with the active PDA001 dose assigned at baseline (2 infusions, 7 days apart).

Intervention Type

Drug

Intervention Name(s)

Vehicle Controlled Placebo

Intervention Description

Cohort Dose Level 1: 4 units vehicle controlled placebp infused on Day 0 and Day 7 Cohort Dose Level 2: 4 units vehicle controlled placebo infused on Day 0 and Day 7

Primary Outcome Measure Information:

Title

Number/Percentage of Participants With an American College of Rheumatology 20% (ACR20) Response within 12 weeks following the initial dose of study drug

Description

Time Frame

Baseline through Week 12

Secondary Outcome Measure Information:

Title

Number/Percentage of Participants With an American College of Rheumatology 20% (ACR20) Response at 6 months

Description

Time Frame

Baseline and 6 months

Title

Number/percent of subjects achieving an ACR 20 clinical response at each scheduled visit during the first 12 months following the first infusion of study drug.

Description

Time Frame

Baseline and each scheduled visit through 12 months following the first infusion of study drug

Title

Number/percent of subjects achieving an ACR 50 clinical response at each scheduled visit during the first 12 months following the first infusion of study drug.

Description

Time Frame

Baseline and each scheduled visit through 12 months following the first infusion of study drug.

Title

Number/percent of subjects achieving an ACR 70 clinical response at each scheduled visit during the first 12 months following the first infusion of study drug.

Description

Time Frame

Baseline and each scheduled visit through 12 months following the first infusion of study drug.

Title

Description

Time Frame

Baseline and each scheduled visit through 12 months following the first infusion of study drug

Title

Description

Time Frame

Baseline and each scheduled visit through 12 months following the first infusion of study drug

Title

Number/Percent of Participants Who Achieve the European League Against Rheumatism (EULAR) Response Criteria Using CRP at Month 12

Description

Time Frame

Baseline and each scheduled visit through 12 months following the first infusion of study drug.

Title

The change from baseline in the ACR core components. ACR Core Component #1: Percentage Change From Baseline in the Swollen Joint Count at each scheduled visit.

Description

Time Frame

Baseline and each scheduled visit through 12 months following the first infusion of study drug

Title

ACR Core Component #2: Percentage Change From Baseline in the Swollen Joint Count at each scheduled visit through Month 12 following the initial infusion of study drug

Description

Time Frame

Baseline and at each scheduled visit through Month 12 following the initial infusion of study drug

Title

ACR Core Component #3 Percentage Change From Baseline in the Subject Assessment of Pain at each scheduled visit through Month 12 following the initial dose of study drug

Description

Time Frame

Baseline and at each scheduled visit through Month 12 following the initial dose of study drug

Title

ACR component #4 Percentage Change From Baseline in the Subject Global Assessment of Disease Activity at each scheduled visit through Month 12 following the initial dose of study drug

Description

Time Frame

Baseline and at each scheduled visit through Month 12 following the initial dose of study drug

Title

ACR Component #5 Percentage Change From Baseline in the Physician Global Assessment of Disease Activity at each scheduled visit through Month 12 following the initial dose of study drug

Description

Time Frame

Baseline and Month 12

Title

Description

Time Frame

Baseline and at each scheduled visit through Month 12 following the initial dose of study drug

Title

ACR Component#7 Percentage Change From Baseline in the High Sensitivity C-Reactive Protein (CRP) at each scheduled visit through Month 12 following the initial dose of study drug

Description

Time Frame

Baseline at each scheduled visit through Month 12 following the initial dose of study drug

Title

ACR Component #8 Percentage Change From Baseline in Erythrocyte Sedimentation Rate (ESR) at each scheduled visit through Month 12 following the initial dose of study drug

Description

Time Frame

Baseline and at each scheduled visit through Month 12 following the initial dose of study drug

Title

Change from baseline in rheumatoid factors at each scheduled visit through Month 12 following the initial dose of study drug

Description

Time Frame

Baseline and each scheduled visit through Month 12 following the initial dose of study drug

Title

Time to flare of Rheumatoid Arthritis (RA) symptoms

Description

Time Frame

At defined intervals

Title

Changes in inflammatory markers including C-reactive protein (CRP), erythrocyte sedimentation rate (ESR), serum amyloid A (SAA), and IL-6

Description

Inflammatory markers are certain laboratory tests performed using the subjects' serum that indicate the presence of RA. Changes in these test results may indicate an improvement in RA

Time Frame

At defined intervals

Title

Change From Baseline in the Disease Activity Score 28 (DAS 28) Using CRP

Description

Time Frame

Baseline and Month 6

Title

Change From Baseline in the Clinical Disease Activity Index (CDAI) at Month 3

Description

Time Frame

Baseline and Month 3

Title

Change From Baseline in the Clinical Disease Activity Index (CDAI) at Month 6

Description

Time Frame

Baseline and Month 6

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Subjects must satisfy the following criteria to be enrolled in the study: Diagnosis of RA as defined by the 1987-revised ACR criteria. RA, characterized by at least 6 out of 66 swollen joints and 6 out of 68 tender joints at Screening and Baseline, and at least 2 of the following: a C reactive protein level (CRP), greater than the upper limit of normal (ULN) ³ 1 mg/dl, an erythrocyte sedimentation rate (ESR) of at least 28 mm per hour, or morning stiffness lasting longer than 45 minutes. Non responsive or intolerant to a minimum of 2 RA therapies which are classified as DMARDs, biologics, or corticosteroids. Biological medication must be discontinued 30 day prior to the first dose of study drug, except golimumab and actemra which are 60 days, and infliximab, alefacept and efalizumab, which must have been discontinued 90 days prior to the first dose of IP. Cytotoxic agents, including but not limited to chlorambucil, cyclophosphamide, nitrogen mustard, or other alkylating agents must have been discontinued 90 days prior to the first dose of IP. Subjects must be able to tolerate intravenous infusions in both arms. There should be no change in RA medication dose anticipated during the initial treatment and re treatment periods and the respective 12 week follow-up period for each dosing treatment period. The following rules apply for anti-rheumatic medications taken during the study: DMARDs must have must have been stable for least 90 days prior to dosing with IP. Low -dose corticosteroids are permitted (prednisolone ≤ 10 mg per day or equivalent). Corticosteroids must have been stable for at least 30 days prior to dosing with IP. DMARDs and corticosteroids must remain stable throughout the initial 3 months of study and throughout subsequent treatment periods The presence of any of the following will exclude a subject from enrollment: Prior use of rituximab and other B-cell depleting therapies, abatacept, prior use of more than 2 biologic therapies. Subject has received an investigational agent in any indication-within 60 days (or 5 half-lives, whichever is longer) prior to treatment with IP. Subject has received previous cell therapy. Serum creatinine concentration > 2.0 mg/dl at screening. Alkaline phosphatase > 2.5x the upper limit of normal at screening. Bilirubin level > 1.5 mg/dL (unless subject has known Gilbert's disease). Untreated chronic infection or treatment of any infection with antibiotics within 4 weeks prior to dosing with IP. Positive HIV test at Screening. Positive Hepatitis B surface antigen at Screening. Positive Hepatitis C antibody at Screening. Organic heart disease (e.g., congestive heart failure), myocardial infarction within six (6) months prior to screening or clinically significant findings on ECG at screening. Clinically significant arrhythmia. Primary or secondary immunodeficiency.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Solveig Ericson, MD

Organizational Affiliation

Celularity Incorporated

Official's Role

Study Director

Facility Information:

Facility Name

Pinnacle Research Group

City

Anniston

State/Province

Alabama

ZIP/Postal Code

36207

Country

United States

Facility Name

Advanced Pain Research Institute

City

Arcadia

State/Province

California

ZIP/Postal Code

91007

Country

United States

Facility Name

UCLA

City

Los Angeles

State/Province

California

ZIP/Postal Code

90095

Country

United States

Facility Name

Desert Medical Advances

City

Palm Desert

State/Province

California

ZIP/Postal Code

92260

Country

United States

Facility Name

Sanitas Research

City

Coral Gables

State/Province

Florida

ZIP/Postal Code

33134

Country

United States

Facility Name

Compass Research, LLC

City

Orlando

State/Province

Florida

ZIP/Postal Code

32806

Country

United States

Facility Name

Progressive Medical Research

City

Port Orange

State/Province

Florida

ZIP/Postal Code

32127

Country

United States

Facility Name

Four Rivers Clinical Research Inc.

City

Paducah

State/Province

Kentucky

ZIP/Postal Code

42003

Country

United States

Facility Name

Arthritis and Diabetes Clinic, Inc

City

Monroe

State/Province

Louisiana

ZIP/Postal Code

71203

Country

United States

Facility Name

St. Paul Rheumatology, PA

City

Eagan

State/Province

Minnesota

ZIP/Postal Code

55121

Country

United States

Facility Name

SNS Rheumatology

City

Lakewood

State/Province

New Jersey

ZIP/Postal Code

08701

Country

United States

Facility Name

David R. Mandel, MD, Inc.

City

Mayfield

State/Province

Ohio

ZIP/Postal Code

44143

Country

United States

Facility Name

Health Research of Oklahoma

City

Oklahoma City

State/Province

Oklahoma

ZIP/Postal Code

73103

Country

United States

Facility Name

Health Research Institute

City

Oklahoma City

State/Province

Oklahoma

ZIP/Postal Code

73109

Country

United States

Facility Name

Altoona Center for Clinical Research

City

Duncansville

State/Province

Pennsylvania

ZIP/Postal Code

16635

Country

United States

Facility Name

Metroplex Clinical Research Center

City

Dallas

State/Province

Texas

ZIP/Postal Code

75231

Country

United States

12. IPD Sharing Statement

Learn more about this trial

Study of Human Placenta-derived Cells (PDA001) to Evaluate the Safety and Effectiveness for Patients With Active Rheumatoid Arthritis

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Study of Human Placenta-derived Cells (PDA001) to Evaluate the Safety and Effectiveness for Patients With Active Rheumatoid Arthritis

Rheumatoid Arthritis

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial