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Pilot Clinical Study Evaluating the Safety and Efficacy of the PrimCell Autologous Cell Separator in the Treatment of Hypopigmented Old Scars: A Single-Center, Single-Arm, Self-Controlled Trial

Pilot Clinical Study Evaluating the Safety and Efficacy of the PrimCell Autologous Cell Separator in the Treatment of Hypopigmented Old Scars: A Single-Center, Single-Arm, Self-Controlled Trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500103420
Enrollment
Unknown
Registered
2025-05-29
Start date
2025-06-04
Completion date
Unknown
Last updated
2025-06-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Scar

Interventions

Intervention Group:The procedure involves harvesting a split-thickness skin graft (0.2-0.3 mm) from a concealed donor site under local anesthesia, followed by enzymatic digestion and mechanical proces

Sponsors

Shanghai Ninth People's Hospital, Shanghai Jiao Tong University School of Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
10 Years to 60 Years

Inclusion criteria

Inclusion criteria: 1. Aged 10 to 60 years (inclusive) 2. Hypopigmented scars with a minimum surface area of 1 cm² 3.Stable hypopigmentation (no progression for >=12 months) confirmed by serial clinical photography 4.History of inadequate response to fractional laser therapy (<=20% repigmentation observed 4 weeks post-treatment via VISIA® analysis)

Exclusion criteria

Exclusion criteria: 1.Suspected keloid predisposition OR History of keloid formation OR Family history of hypertrophic scarring; 2.Active severe dermatoses or autoimmune disorders including: Psoriasis, Scleroderma, Vitiligo, Systemic lupus erythematosus; 3.Uncontrolled Systemic Diseases, clinically significant or unstable systemic conditions that may interfere with safety assessments: Malignancy (within 5-year remission period), Poorly controlled diabetes (HbA1c >8%), Uncontrolled hypertension (BP >160/100 mmHg despite medication), Active pulmonary infections (CT-confirmed), Organic renal/hepatic dysfunction (eGFR 480 ms) 4.Patients and/or legal guardians with unrealistic treatment expectations (validated by Decision Regret Scale score >25)

Design outcomes

Primary

MeasureTime frame
Repigmentation Rate of Hypopigmented Scars;

Secondary

MeasureTime frame
Repigmentation Status of Hypopigmented Scars;Scar Improvement Evaluation;Patient Satisfaction;

Countries

China

Contacts

Public ContactXiaoli Wu

Shanghai Ninth People's Hospital, Shanghai Jiao Tong University School of Medicine

wuxiaoli528@126.com+86 199 7150 7970

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026