Tolerance and Effectiveness of Cell Therapy by Autologous... | NCT02903212

Studies
Tolerance and Effectiveness of Cell Therapy by Autologous Apoptotic Cells in the Treatment of Rheumatoid Arthritis

NCT02903212

Sponsor

Centre Hospitalier Universitaire de Besancon

Status

Unknown status

Last Update Posted

Apr 6, 2022Actual

Enrollment

22Estimated

Phase

Phase 1Phase 2

Conditions

Arthritis, Rheumatoid

Interventions

Autologous apoptotic cells injection

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2022

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 2023Estimated

Primary Completion Date

Jun 2024Estimated

Completion Date

Dec 2024Estimated

First Submitted Date

Sep 1, 2016

First Submission Date that Met QC Criteria

Sep 12, 2016

First Posted Date

Sep 16, 2016Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 5, 2022

Last Update Posted Date

Apr 6, 2022Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The aim of the study is to determine the tolerance of apoptotic autologous cells injection in subjects with active rheumatoid arthritis.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

22Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Rheumatoid arthritis	Experimental	Patients with rheumatoid arthritis. An injection of autologous apoptotic cells is performed on the D0.	Biological: Autologous apoptotic cells injection

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Autologous apoptotic cells injection	Biological	cells injection	Rheumatoid arthritis

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Tolerance of apoptotic cells injection	Side effects are taken into account to assess tolerance.	12 weeks

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients with a diagnosis of Rheumatoid arthritis
Therapy failure with at least one biological agent from anti-TNF-alpha (etanercept, infliximab, adalimumab, certolizumab and golimumab; 3 months at optimal dose), anti-IL6 (tocilizumab; 3 months); T-cell costimulatory pathway inhibitor (abatacept; 3 months); anti-CD20 (rituximab; 6 months at optimal dose); Anti IL-1 (anakinra; 3 months)
Disease Activity Score (DAS) DAS28 ≥ 3.2
Subject has provided written informed consent

Exclusion Criteria:

Pregnant or lactating women
Inflammatory arthritis other than rheumatoid arthritis
History of invasive cancer
Immunodeficiency (HIV infection, Immunosuppressive therapy)
Active bacterial or viral infections, in particular HCV or HBV.
Surgery not older than 4 weeks.
Unstable comorbidities: uncontrolled diabetes, heart disease, advanced renal or hepatic impairment.
Contraindication to an apheresis

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Charline Vauchy, PhD	Contact	+33381218875		cvauchy@chu-besancon.fr
Elise Robert	Contact	0381219086		e1robert@chu-besancon.fr

Overall Officials

Name	Affiliation	Role
Eric Toussirot, Professor	Rhumatology - CHU Besançon	Principal Investigator

Locations

Not provided

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D001172	Arthritis, Rheumatoid

Ancestor Terms

ID	Term
D001168	Arthritis
D007592	Joint Diseases
D009140	Musculoskeletal Diseases
D012216	Rheumatic Diseases

Browse Leaves

Not provided

Browse Branches

Not provided