CELSTEM PRP KIT
Intended Use of the CELSTEM KIT
This kit is used for the separation of autologous platelet rich plasma (PRP) and other plasma-derived products.
This high-demand service is ideal to incorporate into any medical spa or medical practice and can be started with minimal investment and a single day of professional training. CELSTEM PRP kits provide a competitive advantage in the regenerative medical space by offering superlative clinical outcomes at a commercially reasonable cost.
When injected into the skin, PRP stimulates new collagen and elastin formation. Newer studies show that it can also soften sun damage while smoothing and tightening skin. It is an effective treatment in correcting common age-related skin concerns such as dark circles and hollows under the eyes, fine lines, sagging, decreased firmness and uneven tone. The treatment will leave the patient looking more youthful and rejuvenated.
New advances in the use of PRP to help reverse hair loss gives almost anyone the opportunity to turn things around. In this medical treatment for hair loss, PRP is used to stimulate the hair follicles, reversing the hair miniaturization seen in common hair thinning. The platelets are injected throughout the area that is thinning or balding, which supplies the nutrients required to continue growing a thicker, fuller and healthier hair strand.
Although the procedures are slightly different for men and women, both utilize platelet rich plasma (PRP) injected into specific locations in the vagina or on the penis to enhance, rejuvenate, and restore function. PRP can return moisture, sensation, and smooth muscle control to the vagina and urethra in women. In Men, PRP can enhance girth, sensation, and control through micro- vascularization. This treatment may also help to correct urinary incontinence in both sexes.
PRP injections (or platelet rich plasma therapy) is a new treatment method that relieves pain by promoting long lasting healing of musculoskeletal conditions. This rapidly emerging technique is showing exciting potential with osteoarthritis of the knee, shoulder, hip and spine, rotator cuff tears, chronic plantar fasciitis, anterior cruciate ligament (ACL) injuries, pelvic pain and instability, back and neck injuries, tennis elbow, ankle sprains, tendinitis, and ligament sprains.
- It is recommended that a patient should not receive PRP when they have:
- Cancer or metastatic disease
- An active infection
- A low platelet count
- Pregnant or breastfeeding
Warnings and Precautions:
- FOR SINGLE USE ONLY
- Use PRP only on the same patient from whom the blood was drawn.
- Autologous PRP must be prepared from fresh blood and used within four hours.
- Use appropriate safety precautions to protect yourself from needles and blood products.
- Samples of blood should be regarded as potentially infectious.
- Discard the entire CELSTEM kit after single use.
- Do not reuse.
- The product should be discarded and treated as a potentially infectious blood product.
- The product should be discarded into biological hazard container.
- Do not use if the packing is damaged or open. Do not resterilize.
- Do not use product if foreign matter is present in the tube.
- Storage above 40C may damage the gel stability.
- Storage of CELSTEM tubes with blood at or below 0 C may result in tube breakage.
- Do not underfill tubes with blood as an incorrect blood to additive ratio may result in poor product performance.
- Follow the manufacturer’s instructions when using SURE SPIN centrifuge.
- Do not use excessive centrifugation as it may result in breakage of the tube.
- Do not use after the expiry date
Possible adverse effects
- Temporary or permanent nerve damage that may result in pain or numbness
- Damage to blood vessels/hematomas
Storage and stability
- Store at room temperature 15 – 30C
Do not expose to sunlight
- Do not use if the sterile package is damaged.
- Do not use after expiry date
Instructions for Use
Important: Use standard aseptic technique throughout the following procedure.
1. Open the pack and remove a CELSTEM tube
2. Draw blood from the patient using standard venous puncture procedures and fill the PlateRich vacuum tube with whole blood (approximately 8 ml). The vacuum should automatically collect the correct amount of whole blood. A 19 – 21G butterfly needle is recommended.
3. Invert the tube several times to ensure the anticoagulant is mixed with the blood.
4. Place the tube into the centrifuge. Always ensure the Sure Spin is correctly balanced before beginning the centrifuge (counterbalance with a CELSTEM tube filled with water)
5. Sure Spin at 350 (RFC) for 8 minutes
6. After centrifugation, the red blood cells and most of the white blood cells will be below the plug of gel.
7. Gently invert the CELSTEM tube several times to re-suspend the platelets in the plasma. Approximately, 2 – 4 ml of plasma will be available.
8. Withdraw the PRP with a sterile syringe and needle, the PRP is now ready for use.
9. Alternatively, if you wish to concentrate the platelets in a smaller volume of plasma. Prior to
inverting and resuspending the platelets gently remove the top half of the plasma (the platelet poor
plasma). Then gently invert the CELSTEM tube several times to re-suspend the concentrated platelets in
the remaining plasma