مشخصات
| پارامتر | اطلاعات محصول |
|---|---|
| طبقهبندی منبع | بافت آلوژنیک انسانی؛ ماتریکس درمال بدون سلول (تزریقی/پودر) |
| شکل عرضه | 160 mg |
| اندازه ذرات | <75 µm |
| استریلیزاسیون | پرتو الکترونی |
| نگهداری | 1–30°C |
| مدت ماندگاری | 36 ماه از تاریخ تولید |
| محتویات بسته | کلاژن درمال، 1 سرنگ اختلاط، 2 آداپتور، 3 سوزن |
ترکیب
| ترکیب | مقدار |
|---|---|
| کلاژن | 85%+ |
| الاستین | 3.4%+ |
| GAGs | 0.9%+ |
| سایر اجزای ECM | 10.7%+ |
فناوری و مواد
بروشور حذف اجزای سلولی و اسیدهای نوکلئیک در فرایند سلولزدایی را توضیح میدهد. مقدار dsDNA در ماده اولیه 1399.5 ng/mg و در گرافت فرآوریشده 0.09 ng/mg و زندهمانی سلولی در آزمون آزمایشگاهی 85.70% گزارش شده است. این اعداد، نتایج ارزیابی منبع سازندهاند.
ارزیابی گزارششده در کاتالوگ
بروشور تغییرات نسبت به خط پایه را در هفتههای 1، 2 و4 پس از درمان گزارش میکند. این درصدها نتایج گزارششده مطالعهاند و نتیجه فردی را تضمین نمیکنند.
| شاخص ارزیابی | ۱ هفته | ۲ هفته | ۴ هفته |
|---|---|---|---|
| بافت پوست | +5.00% | +10.04% | +14.71% |
| تون پوست | +2.18% | +3.96% | +5.34% |
| تراکم درم | +2.34% | +5.96% | +11.79% |
| کشسانی پوست | +8.28% | +11.72% | +19.31% |
| آبرسانی عمقی | +4.46% | +7.81% | +10.90% |
آمادهسازی حرفهای
| پارامتر | اطلاعات محصول |
|---|---|
| N/S | 4 mL |
| HA بدون اتصال عرضی | 2 mL |
| لیدوکائین | 1 mL |
| سوزن | 33G / 34G |
| کانولا | 23G / 25G |
کاربری و مراقبت پس از آن
فقط یکبارمصرف؛ استفاده یا استریلیزاسیون مجدد ممنوع است. راهنمای منبع، هیدراتاسیون با سالین پیش از ترکیب با HA بدون اتصال عرضی و لیدوکائین را شرح میدهد؛ راهنمای کامل هشتمرحلهای در متن انگلیسی و PDF اصلی حفظ شده است.
جزئیات کامل منبع انگلیسی
متن کامل انگلیسی راهنمای محصول در پایین حفظ شده است. معرفی و جدولهای ترجمهشده بالا بازآرایی ساختاریافته مطالب هستند؛ فایل PDF سند اصلی سازنده یا منبع است.
Formulated with advanced extracellular matrix (ECM) components, CellREDM™ is a high-purity ADM skin booster that helps reinforce the skin’s structural framework and supports comprehensive improvement in dermal density, elasticity, and texture through the synergistic activity of collagen, elastin, and glycosaminoglycans (GAGs) delivered in a micro-particle form.
ECM components and the skin’s structural framework
CellREDM™ is formulated with advanced ECM (extracellular matrix) components, offering excellent tissue compatibility and promoting natural responses aligned with the skin’s regenerative cycle and physiological rhythms, leading to predictable and reliable rejuvenation effects.
Its ECM composite combines collagen, elastin, and GAGs to support ECM remodeling and restoration of the fibroblast environment.
| Feature | Skin Booster (General) | CellREDM™ | Collagen Booster |
|---|---|---|---|
| Origin | Synthetic ingredient-based product | ECM-based products | Animal-derived product |
| Main components | Synthetic polymers / nucleic acids / protein-based | ECM composite components (Collagen + Elastin + GAGs) | Purified single collagen (atelocollagen) |
| Mechanism of action | Cell activation / growth factor expression / inflammation-mediated regeneration | ECM remodeling and restoration of the fibroblast environment | Primarily collagen supplementation |
| Biocompatibility | Moderate (inflammation-based reactions possible) | High (minimal immune response) | Low–moderate (immune reaction caution needed) |
Micro-particles for tissue-friendly absorption
Processed into ultra-fine particles smaller than 75 μm, CellREDM™ disperses naturally within the skin tissue, enabling uniform and stable absorption. This minimizes post-procedure complications such as swelling or nodules and supports faster recovery.
- Particle size under 75 μm.
- Uniform dispersion within skin tissue.
- Stable absorption and treatment safety.
A synergistic complex of collagen, elastin, and GAGs
The multi-component formulation goes beyond simple hydration to enhance skin density, improve elasticity, and reduce fine lines. By stimulating fibroblast activity, it supports gradual and natural skin structure recovery through intrinsic regeneration, making it a comprehensive ECM-based skin booster.
| Component | Composition shown in brochure | Role |
|---|---|---|
| Collagen | 85%+ | Skin structure reinforcement; wrinkle improvement |
| Elastin | 3.4%+ | Elasticity improvement |
| GAGs (glycosaminoglycans) | 0.9%+ | Deep hydration and moisture retention |
| Other ECM | 10.7%+ | Skin self-repair support; structural restoration |
Decellularization and tissue compatibility
Cellular components and nucleic acids (DNA and RNA) that may trigger immune responses have been effectively removed.
The brochure illustrates cell removal with H&E and DAPI staining. H&E staining visualizes cells in purple and tissue in pink. DAPI binds to nuclear DNA and produces blue fluorescence.
| Assessment | Before | After |
|---|---|---|
| H&E (Hematoxylin & Eosin staining) | Numerous cells are present within the tissue. | Cells are removed, leaving only the tissue structure. |
| DAPI staining | Many cells are present, showing widespread blue fluorescence. | Cells are almost completely removed; blue fluorescence is barely visible. |
| Measurement | Result |
|---|---|
| Raw material dsDNA | 1399.5 ng/mg |
| Processed graft dsDNA | 0.09 ng/mg |
| Reduction shown in brochure | 99.99% |
In vitro cell compatibility
CellREDM™ was evaluated in vitro to assess cell compatibility with the processed tissue. The processed CellREDM™ donor, with immunogenic components removed, showed high cell viability, demonstrating high compatibility.
The brochure states that cytotoxicity can be analyzed using qualitative or quantitative methods, with quantitative assessment preferred. In quantitative evaluation, a decrease in cell viability of 30% or more is considered indicative of cytotoxicity. The reference standard listed in the brochure is ISO 10993-5:2009.
| Test group | Cell viability |
|---|---|
| Negative (not treated) | 100.00% |
| Positive (DMSO) | 3.20% |
| Control group (MEM medium) | 100.73% |
| Processed graft / CellREDM™ | 85.70% |
Clinical evaluation results
CellREDM™ was found to improve skin texture, skin tone, elasticity, deep hydration, and dermal density at all evaluation points at 1 week, 2 weeks, and 4 weeks after treatment.
In the efficacy questionnaire, 100% of participants responded positively for all evaluation items at 1, 2, and 4 weeks post-treatment. No adverse skin reactions were observed in any participants throughout the study period.
The skin texture, skin tone, and dermal density measurements are credited in the brochure to Skin Clinical Imaging Center.
| Evaluation item | 1 week | 2 weeks | 4 weeks |
|---|---|---|---|
| Skin texture | +5.00% | +10.04% | +14.71% |
| Skin tone | +2.18% | +3.96% | +5.34% |
| Dermal density | +2.34% | +5.96% | +11.79% |
| Skin elasticity | +8.28% | +11.72% | +19.31% |
| Deep hydration | +4.46% | +7.81% | +10.90% |
Preparation materials and guide
Preparation materials listed in the brochure: CellREDM™, N/S, non-crosslinked HA, lidocaine, and a 33G or 34G needle. Preparing an additional 10 cc syringe can be helpful during setup.
| Item | Specification or amount |
|---|---|
| Needle | 33G or 34G |
| Cannula | 23G or 25G |
| N/S | 4 ml |
| Non-crosslinked HA | 2 ml |
| Lidocaine | 1 ml |
Procedure steps from the manufacturer’s guide
- 1. Prepare 4 cc of saline.
- 2. Pull back the plunger of the syringe containing CellREDM™ Powder by approximately 0.2–1 cc.
- 3. Tap the syringe gently to loosen any clumped powder.
- 4. Attach the adapter and inject 4 cc of saline into the CellREDM™ Powder syringe.
- 5. Hold one syringe in each hand and alternate pushing the plungers back and forth slowly at least 20 times until fully hydrated.
- 6. Mix the fully hydrated CellREDM™ with 2 cc of non-crosslinked HA.
- 7. Mix the combined solution with 1 cc of lidocaine.
- 8. Dispense the fully mixed CellREDM™ into 1 cc syringes for injection.
Mixing tips and handling
- Pulling the powder toward the back space first helps create room for hydration and improves mixing efficiency.
- If excessive foam forms during hydration, eliminate the empty space inside the syringe, then resume mixing.
- If air bubbles remain, push the plunger upward to remove them. If they cannot be removed easily, loosen the adapter slightly.
- Single-use only; do not reuse or re-sterilize.
- Store at room temperature between 1°C and 30°C.
- Shelf life: 36 months from the date of manufacture.
Manufacturer background
The brochure describes 20 years of expertise in advanced biomaterial processing, beginning with the establishment of Korea’s first MFDS-approved tissue bank in 2005.
It presents the manufacturer’s Korea MFDS-approved tissue bank, AATB certification, and USA FDA registration, and recognition by the Korean Government’s National Quality Innovation Competition for excellence in manufacturing innovation, reliability, and customer value.
- Manufacturer identified in the brochure: Hans Biomed Corporation.
- The reproduced FDA establishment registration lists FEI 3003828812 and the last annual registration year as 2025.
استعلام حرفهای
نام شرکت، کشور مقصد، مدل و تعداد موردنیاز را ذکر کنید. برنامه ایمیل باز میشود؛ استعلام خودکار ارسال یا ذخیره نمیشود.
alexmoon@ictmedicalco.com ↗