ADRCs in The Treatment of Hand Dysfunction Due to Scleroderma (STAR-II)

September 26, 2022 updated by: Paracrine, INC.

Scleroderma Treatment With Celution Processed Adipose Derived Regenerative Cells - A Randomized, Double-Blind, Placebo-Controlled Study - The STAR-II Trial

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Anticipated)

174

Phase

  • Phase 3

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: ADRC Arm
Subjects in the ADRC arm will receive standard care and active treatment (ADRCs)
Device: ADRCs
Adipose Derived Regenerative Cells (ADRCs) processed with Celution System
Other: Standard Care
Standard care
PLACEBO_COMPARATOR: Standard Care Arm
Subjects in the Standard Care arm will receive standard care and Placebo
Other: Standard Care
Standard care
Other: Placebo
Placebo visually indistinguishable from ADRCs

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Paracrine, INC.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ANTICIPATED)

February 28, 2023

Primary Completion (ANTICIPATED)

December 30, 2024

Study Completion (ANTICIPATED)

December 30, 2025

Study Registration Dates

First Submitted

November 20, 2021

First Submitted That Met QC Criteria

December 2, 2021

First Posted (ACTUAL)

December 8, 2021

Study Record Updates

Last Update Posted (ACTUAL)

September 28, 2022

Last Update Submitted That Met QC Criteria

September 26, 2022

Last Verified

December 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • STAR-II, 2021-03.V1

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

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

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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