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

Primary Purpose

Scleroderma, Diffuse

Status
Not yet recruiting
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
ADRCs
Standard Care
Placebo
Sponsored by
Paracrine, INC.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Scleroderma, Diffuse focused on measuring Hand Dysfunction, Scleroderma, Scleroderma, Diffuse

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Placebo Comparator

    Arm Label

    ADRC Arm

    Standard Care Arm

    Arm Description

    Subjects in the ADRC arm will receive standard care and active treatment (ADRCs)

    Subjects in the Standard Care arm will receive standard care and Placebo

    Outcomes

    Primary Outcome Measures

    Cochin Hand Function Score
    Cochin Hand Function Score

    Secondary Outcome Measures

    Full Information

    First Posted
    November 20, 2021
    Last Updated
    September 26, 2022
    Sponsor
    Paracrine, INC.
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05148598
    Brief Title
    ADRCs in The Treatment of Hand Dysfunction Due to Scleroderma
    Acronym
    STAR-II
    Official Title
    Scleroderma Treatment With Celution Processed Adipose Derived Regenerative Cells - A Randomized, Double-Blind, Placebo-Controlled Study - The STAR-II Trial
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    December 2021
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    February 28, 2023 (Anticipated)
    Primary Completion Date
    December 30, 2024 (Anticipated)
    Study Completion Date
    December 30, 2025 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Paracrine, INC.

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    Yes
    Device Product Not Approved or Cleared by U.S. FDA
    Yes
    Product Manufactured in and Exported from the U.S.
    No
    Data Monitoring Committee
    No

    5. Study Description

    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
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Scleroderma, Diffuse
    Keywords
    Hand Dysfunction, Scleroderma, Scleroderma, Diffuse

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 3
    Interventional Study Model
    Parallel Assignment
    Model Description
    Prospective Randomized Parallel Group Placebo-Controlled Safety and Efficacy Trial
    Masking
    ParticipantCare ProviderInvestigatorOutcomes Assessor
    Masking Description
    Placebo is visually indistinguishable from active treatment.
    Allocation
    Randomized
    Enrollment
    174 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    ADRC Arm
    Arm Type
    Experimental
    Arm Description
    Subjects in the ADRC arm will receive standard care and active treatment (ADRCs)
    Arm Title
    Standard Care Arm
    Arm Type
    Placebo Comparator
    Arm Description
    Subjects in the Standard Care arm will receive standard care and Placebo
    Intervention Type
    Device
    Intervention Name(s)
    ADRCs
    Intervention Description
    Adipose Derived Regenerative Cells (ADRCs) processed with Celution System
    Intervention Type
    Other
    Intervention Name(s)
    Standard Care
    Intervention Description
    Standard care
    Intervention Type
    Other
    Intervention Name(s)
    Placebo
    Intervention Description
    Placebo visually indistinguishable from ADRCs
    Primary Outcome Measure Information:
    Title
    Cochin Hand Function Score
    Description
    Cochin Hand Function Score
    Time Frame
    26 weeks

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    70 Years
    Accepts Healthy Volunteers
    No
    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

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    IPD Sharing Plan Description
    Individual participant data (IPD) will not be made available.

    Learn more about this trial

    ADRCs in The Treatment of Hand Dysfunction Due to Scleroderma

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