The stem cells produced by SCLnow® are from medical waste – umbilical cord tissue (not cord blood, not placenta) without ethical issues, and with “SCLnow® Informed Consent Form” and “SCLnow® Health Questionnaire Form”signed by donors.
SCLnow® is committed that its development,or the process of production will not harm human survival, nor bring harms to the social development. It will not cause damage to the ecological environment,but stick to commercial morality, and abide by corporate integrity.
SCLnow® is committed that its development,or the process of production will not harm human survival, nor bring harms to the social development. It will not cause damage to the ecological environment,but stick to commercial morality, and abide by corporate integrity.
[clinicalstorage level product name]
General ChineseName：Umbilical cord Mesenchymalstem cells
GeneralEnglish Name: Umbilical Cord Mesenchymal Stem cells
iSCLstem cell® cell seeds
ProductName: iSCLstem cell
Chinese Pinyin: ShengBaoer Ganxibao Zhongzi
SCLnow® has clinical andserum-free culture system with its own independent intellectual property rightsto ensure efficient amplification of iSCLstem cell®, and maintain its highproliferative capacity and undifferentiated state during continuous passage invitro. The quality stability and safety of iSCLife® are guaranteed by and from iSCLstem cell® seeds.
[Ingredients]:The main ingredients of this product: SCLnow® umbilical cord mesenchymal stem cells; accessories: SCLnow® cryoprotectant.
[Character]This product is a nearly colorless micro-suspension liquid stored in -196℃ liquid nitrogen storage system of SCLnow® Life Energy Bank
iSCLstemcell® seeds are evenly suspended in cryoprotectants to avoid highconcentrations of external solute damage while avoiding excessive dehydrationand shrinkage of stem cells.In addition, cryopreservation protectant will alsoprevent the damage of intracellular ice crystals to stem cellseeds.Therefore,iSCLstem cell® seedsstored in the SCL Bank® are in a static state oflife activity and can be permanently preserved.
[Packagingmaterials]: CEIVD certification: non-toxic, non-pyrogen, non-mutagens,
USP (VIlevel) SCLnow® tailor-made ultra low temperature 2D (2-Dimensional Barcode)freezing tube;
[Specification]:5SCL unit (U); 1SCL unit (U) =10,000,000 seed cells
[Adverseeffects]: Not yet clear.
[Contraindication]:Not yet clear.
[Storage]:-196℃ cryopreservation system and sealed
[Validity]:Permanent preservation
[Implementationstandard] Quality management system conforms to GB/T19001-2016/ISO9001:2015standard.
[Approvalnumber] 016ZB17Q30654R1M; ABZB17Q30194R1M
[Productionenterprise]
Companyname: SCLnow®(Beijing) Bioengineering Co., Ltd.
Productionaddress: SCLnow®Fairyland, 39 East Reed Road,Chaoyang District, Beijing
Postal Code:100018
Tel:010-010-5511
[clinical use level product name]
Standard Chinese Name: umbilical cord mesenchymal stem cell standardpreparation
General English Name: Umbilical Cord Mesenchymal Stem cells I.V. DripPreparations
Chinese Name: clinical standard preparation of cytosolic derived stemcells
Commodity name: iSCLife I.V. Drip Preparations
Chinese Pinyin: ShiBaoer Ganxibao Zhiji
[Ingredients]
The main ingredients of this product are: SCLnow® umbilical cordmesenchymal stem cells and SCLnow® stem cell functional protein,SCLnow®cytokines, etc. Accessories: physiological saline for injection.
[Character]
This product is a nearly colorless or light red micro suspension liquid.
[Packaging materials]
multi layer co extrusion infusion bag
[Specification]
50ml = 5SCL unit (U) and 50mg SCLnow® stem cell functional protein and SCLnow® cytokines; 1SCL unit (U) = 10,000,000 stem cells
[Dosage]
Intravenous infusion: According to physical condition and doctor's advice,
determine the number and mode of transplantation. Intravenous drip of 5mgDexamethasone
Sodium Phosphate Injection before use.[Warning]
1. The suspension liquid should be transportedin cold chain at 2℃-8℃, and be used within the validity period.
2. Leukocyte increasing drugs such asbacterial factors should not be used within 48 hours before and aftertransplantation.
3. Avoid alcohol after transplantation.
4. In case of adversereactions after transplantation, symptomatic treatment should be performedpromptly
[Adverse reactions]
1. It is a normal phenomenon to have anoccasionally transient fever when body temperature
does not exceed 38.5 degrees and in general comes to natural subsidencewithin 12 hours
2. It is a normal phenomenon to have an occasional feeling of a slightpressure in head.
3. It is a normal phenomenon to have sleep disorders on the day oftransplantation.
[Contraindication]:Not yet clear.
[Pregnancy and lactation women]: Prohibited for pregnancy inducedhypertension syndrome.
The volume and speed of fluid infusion should be strictly controlled.
[Storage]: Sealed and preserved at 2℃-8℃
[Validity period]: Valid preservation period is 7 days at 2℃-8℃ .
[standard]: Quality management system conforms toGB/T19001-2016/ISO9001:2015 standard.
[Approval number] 016ZB17Q30654R1M; ABZB17Q30194R1M
[Production enterprise]
Company name: SCLnow®(Beijing) Bioengineering Co., Ltd.
Production address: SCLnow® Fairyland, 39 East Reed Road, Chaoyang District,Beijing
Postal Code: 100018
VIP special line: 400-010-5511
[Adapt to crowd]
1. Dysfunction or low regulation of immunesystem such as immunodeficiency disease, chronic infection and adjuvantchemotherapy for cancer.
2. Low endocrine regulation or disorders suchas diabetes, fatty liver, cirrhosis, nephritis, renal failure adjuvant therapy.
3. Regeneration of nerve system such asParkinson's disease, Alzheimer's disease, cerebrovascular accident, adjuvanttreatment and recovery of spinal cord injury.
4. Those who wish to prevent aging, maintainbody rejuvenation, pursue young facial beauty.
5. Those in high pressure, stressful work and sub-healthy condition;
6. Those who have degenerative diseases including endocrine and sexualfunction decline, cardiovascular system functional degeneration, skeletal motorsystem degeneration, the immune system decline and the nervous system functiondeterioration.
7. Female climacteric syndrome;
[Restrictions]
1. Serious impairment of vital organs such as heart, liver, kidney andlungs.
2. People with serious or uncontrolled infections.
3. People with severe drug allergy history.
4. People with severe mental disorders.
5. Pregnant women.
[Pharmacology and toxicology]
1. Umbilical cord mesenchymal stem cells (UCMSCs) are derived from humanbody itself and cultured in serum-free medium throughout the culture process.Xenovirus infection is not introduced in the application process; thefunctional proteins and cytokines of umbilical cord mesenchymal stem cells arederived from the culture process of umbilical cord. No heterologous proteinwill be introduced during the application, and no allergic reaction will beinduced.
2. Experimental data In vitro showed that umbilical cord mesenchymal stemcells did not express the oncogenic gene c-Myc, but continuously express thetumor suppressor gene p53, which proved that umbilical cord mesenchymal stemcells were not oncogenic.
3. Experimental data in vivo show that there is no difference in cachexiaand tumorigenesis between umbilical cord mesenchymal stem cell treatment groupand control group. Long-term observation (15 years) also found no increase inpathogenic microbial infection and mesenchymal stem cell tumorigenesis.
[Pharmacokinetics]
Intravenous injection of mesenchymal stem cells directly enters the bloodcirculation. Mesenchymal stem cells have a low immune prototype and do notcause immune rejection.
1. Mesenchymal stem cells (MSCs) migrate to inflammation, injury and tumorsites in blood circulation covering the whole body, and differentiate intofunctional cells under local microenvironment.
2. Mesenchymal stem cells secrete various bioactive substances such asgrowth factors, cytokines, chemokines and regulatory peptides through paracrinepathways.These bioactive substances can regulate metabolism, celldifferentiation, proliferation, repair tissue damage and angiogenesis.
3. Mesenchymal stem cells improve local microenvironment through paracrinepathway, promote the activation, proliferation and differentiation of their ownstem cells, and self-repair lesion tissue.
SCLnow® rawmaterial umbilical cord collection and iSCLife® I.V. DripPreparations
SCLnow® takes customer’s demand as its own mission and adopts GPS positioning cold chaintransportation in the whole process either by sea, air or land.
- cold chain transportation (2-8℃)
- cloud system real-time monitoringtemperature display (abnormal alarm)
- GPS positioning system for wholetransportation
- print shipping data on site (one datarecord per 2H)
- data management of cloud system (data uploaded to SCL-CC)
[Product name]
Standard Chinese Name: HumanUmbilical Cord Mesenchymal Stem cells Factor
General English Name: HumanUmbilical Cord Mesenchymal Stem cells Factor
Chinese Name: iSCLCODE®
Commodity name: iSCLCODE®
[Main ingredients]
UC-MSC secretory proteins, cytokine etc.
Accessories: water for injection
[Characteristics]
At roomtemperature, this product is in form of liquid in color from light pink tolilac without fragrance
[Specifications]
8ml：40mg。
[Usage and dosage]
Afterthe skin is cleaned, apply a proper amount of this product evenly to therequired skin.
Because this product has UC-HA,UC-collagen,UC-MSC secretory proteins, cytokine etc., please keep the remainder in refrigeratorafter use and preserve in freezer at -20 ℃ for along-term storage
[Efficacy anddynamics]
1.Nanoscale components are easy for skin toabsorb. UC-HA promotes the proliferation and differentiation of epidermal cells,reduces fine lines, keeps the dermis in 25%-30% moisture, scavenges oxygen freeradicals, reconstructs, repairs and regenerates the skin.
2.Nanoscalecomponents are easy for skin to absorb. UC-collagen has a natural moisturizingfunction. The three spiral structure reaches the stratum corneum and locks themoisture. It nourishes the skin, strengthens the skin metabolism, maintains theintegrity of the skin fiber and makes the skin achieve the function of skinlightening, tightening and moisturizing.
3.Nanoscale components are easy for skin toabsorb, and on the skin surface, form an active polymer screen membranecomposed of UC-MSC secretory proteins and cytokine to activate skin cells inbasal skin layer from the dormancy state to the best active state of growthfactors.
4.UC-MSC cytokinescan deeply reconstruct from the dermis to cuticles, which stimulate fiber cellsto form collagen and elastin. The reconstruction promotes the skin metabolismand recharges the damaged skin cells with necessary energy and nutrition. Itstrengthens the regular skin functions including anti-oxidation,anti-ultraviolet, anti-bacteria and restores the normal metabolism forall-around skin repair and maintenance
5.Small molecule functional proteins and cytokines canmake cells restored to the young state, improving transport function andexchange ability of the cell membrane materials. They improve the respiratoryfunction inside a cell and promote the active transport of cell nutrients fromoutside into the cell in order to increase the nutrition inside the cell. Thispromotes dermal cells to secrete and synthesize functional molecules such ascollagen, polysaccharides, glycoproteins etc. These functional moleculesenhance cell metabolism and make the subcutaneous dermis tissue plump and themuscle fibers evenly and tightly laid out to prolong cell senescence, and hencereduce and eliminate wrinkles.
[Adapt to skin]
1. All types of Oily, mixed, dull, water deficient andlarge pores skin
2. Treatment on all kinds of acne, pimple skinand hormone dependent dermatitis
3. Dull, rough and lusterless skin caused by workingpressure or lack of sleep etc.
4. Skin laxity, small wrinklesand lack of elasticity caused by degenerative aging
[Caution]
1. People with severeallergic constitution should use cautiously
2.People should use cautiously in case of red, swollen, hotitching, painful skin mucous
membrane and eczema caused by bacteria or virus.
[Warning]
1. Thisproduct contains bio-active components and should be transported with coldchain at -20℃ and used within the period of validity.
2. In caseof adverse reaction after use, it should be treated in time.
3. Thisproduct cannot replace pharmaceuticals
[Storageconditions]
Sealed preservation at 2-8 ℃ or -20 ℃
[Term ofvalidity]
Theduration of preservation is 30 days at 2-8℃ or six months at-20℃.
[Standard]
Conform to quality control system of GB/T19001-2016/ISO9001:2015version
[Approval Number]
016ZB17Q30654R1M；ABZB17Q30194R1M
[Manufacturer]
CompanyName：SCLGL® Regernative Medicine Space
Address: SCLnow Fairland,Tianan Golf,NO.39,Dongwei road,Chaoyang District,Beijing,
Postcode: 100018
Telephone: 010-010-5511
[Usagesteps]
1. openbox, take out iSCLCODE®
2.,open the purple bottle cap.
3.rotate clockwise and open the bottle cap.
4. openthe rubber stopper.
5. puton special iSCLCODE® emitter
6.remove the cap and squeeze the dripping head
With regard to cell level, molecular level, gene level and protein level, the third-party review test (China Food and Drug Inspection Institute) and the safety test (CNAS Beijing Dean Clinical Inspection Institute) provide a complete set of 43 quality control tests for stem cell life energy in data tracing. 28 of them are functional tests, and 15 are safety tests. The product has high purity (over 98%), high activity (over 99.7%) and wide differentiation potential (widely used in anti-aging and disease treatment) without matching.
