ADRCs in The Treatment of Hand Dysfunction Due to Sclerod... | NCT05148598

Studies
ADRCs in The Treatment of Hand Dysfunction Due to Scleroderma

NCT05148598

Sponsor

Paracrine, INC.

Status

Unknown status

Last Update Posted

Sep 28, 2022Actual

Enrollment

174Estimated

Phase

Phase 3

Conditions

Scleroderma, Diffuse

Interventions

ADRCs
Standard Care
Placebo

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

Dec 2021

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

Feb 28, 2023Estimated

Primary Completion Date

Dec 30, 2024Estimated

Completion Date

Dec 30, 2025Estimated

First Submitted Date

Nov 20, 2021

First Submission Date that Met QC Criteria

Dec 2, 2021

First Posted Date

Dec 8, 2021Actual

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

Sep 26, 2022

Last Update Posted Date

Sep 28, 2022Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Yes

Is Unapproved Device

Yes

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The primary objective of this study is to assess the safety and efficacy of the Celution Device in the processing of an autologous graft consisting of adipose derived regenerative cells (ADRCs) in the treatment of hand dysfunction due to scleroderma.

Detailed Description

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 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

174Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
ADRC Arm	Experimental	Subjects in the ADRC arm will receive standard care and active treatment (ADRCs)	Device: ADRCs Other: Standard Care
Standard Care Arm	Placebo Comparator	Subjects in the Standard Care arm will receive standard care and Placebo	Other: Standard Care Other: Placebo

Interventions

Name	Type	Description	Arm Group Labels	Other Names
ADRCs	Device	Adipose Derived Regenerative Cells (ADRCs) processed with Celution System	ADRC Arm

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Cochin Hand Function Score	Cochin Hand Function Score	26 weeks

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Key Inclusion Criteria:

Diffuse cutaneous scleroderma (duration > 5 years)
Cochin Hand Function Scale ≥ 20 units
Symptoms consistent with Raynaud's Phenomenon
Ability to safely undergo liposuction

Key Exclusion Criteria:

Active infection
Contracture(s) of any finger
Sympathectomy within 6 months of Screening Visit
Rheumatoid Arthritis

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

70 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

IPD Sharing Statement Module

Plan to Share IPD

Description

Individual participant data (IPD) will not be made available.

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D045743	Scleroderma, Diffuse

Ancestor Terms

ID	Term
D012595	Scleroderma, Systemic
D003240	Connective Tissue Diseases
D017437	Skin and Connective Tissue Diseases
D012871	Skin Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D059039	Standard of Care

Ancestor Terms

ID	Term
D019984	Quality Indicators, Health Care
D011787	Quality of Health Care
D006298	Health Services Administration
D017530	Health Care Quality, Access, and Evaluation

Browse Leaves

Not provided

Browse Branches

Not provided