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

Paracrine

Status and phase: Not yet enrolling; Phase 3

Conditions: Scleroderma, Diffuse

Treatments: Other: Standard Care; Device: ADRCs; Other: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT05148598

STAR-II, 2021-03.V1

Details and patient eligibility

About

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.

Full 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.

Enrollment: 174 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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174 participants in 2 patient groups, including a placebo group

ADRC Arm

Experimental group

Description:

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

Treatment:

Other: Standard Care

Device: ADRCs

Standard Care Arm

Placebo Comparator group

Description:

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

Treatment:

Other: Placebo

Other: Standard Care