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ECM基质无细胞真皮产品

CellREDM™

CellREDM 被描述为高纯度ADM肌肤焕活产品,含胶原、弹性蛋白及GAGs等真皮基质成分。制造商注明其为人同种异体组织,微粒小于75 µm,规格为160 mg。

CellREDM™ — ECM基质无细胞真皮产品

规格参数

项目产品信息
来源分类人同种异体组织;无细胞真皮基质(注射用/粉末)
包装形式160 mg
粒径<75 µm
灭菌方式电子束
储存1–30°C
保质期生产日起36个月
包装内容真皮胶原、1支混合注射器、2个接头、3支针头

成分组成

成分含量
胶原85%+
弹性蛋白3.4%+
GAGs0.9%+
其他ECM10.7%+

技术与材料

手册说明脱细胞过程中去除细胞成分及核酸,报告原料dsDNA为1399.5 ng/mg、处理后移植物为0.09 ng/mg,体外试验细胞存活率为85.70%。这些为制造商资料所载的评估数据。

目录所载评估结果

手册报告治疗后1、2及4周相对基线的变化。这些百分比是资料所述研究结果,不保证个体效果。

评估项目1周2周4周
肤质+5.00%+10.04%+14.71%
肤色+2.18%+3.96%+5.34%
真皮密度+2.34%+5.96%+11.79%
皮肤弹性+8.28%+11.72%+19.31%
深层水分+4.46%+7.81%+10.90%

专业人员配制信息

项目产品信息
N/S4 mL
非交联HA2 mL
利多卡因1 mL
针头33G / 34G
钝针23G / 25G

使用注意事项与后续护理

仅限一次性使用,不得重复使用或重新灭菌。来源说明先用盐水水化,再与非交联HA及利多卡因混合;完整八步指南保留于英文详细资料及原始PDF中。

完整英文原始详情

下方保留产品指南的完整英文文本。上方本地化介绍及规格表是对资料的结构化整理;PDF 保留制造商或来源的原始文件。

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.

FeatureSkin Booster (General)CellREDM™Collagen Booster
OriginSynthetic ingredient-based productECM-based productsAnimal-derived product
Main componentsSynthetic polymers / nucleic acids / protein-basedECM composite components (Collagen + Elastin + GAGs)Purified single collagen (atelocollagen)
Mechanism of actionCell activation / growth factor expression / inflammation-mediated regenerationECM remodeling and restoration of the fibroblast environmentPrimarily collagen supplementation
BiocompatibilityModerate (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.

ComponentComposition shown in brochureRole
Collagen85%+Skin structure reinforcement; wrinkle improvement
Elastin3.4%+Elasticity improvement
GAGs (glycosaminoglycans)0.9%+Deep hydration and moisture retention
Other ECM10.7%+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.

AssessmentBeforeAfter
H&E (Hematoxylin & Eosin staining)Numerous cells are present within the tissue.Cells are removed, leaving only the tissue structure.
DAPI stainingMany cells are present, showing widespread blue fluorescence.Cells are almost completely removed; blue fluorescence is barely visible.
MeasurementResult
Raw material dsDNA1399.5 ng/mg
Processed graft dsDNA0.09 ng/mg
Reduction shown in brochure99.99%

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 groupCell 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 item1 week2 weeks4 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.

ItemSpecification or amount
Needle33G or 34G
Cannula23G or 25G
N/S4 ml
Non-crosslinked HA2 ml
Lidocaine1 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.

专业业务咨询

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