Regenkit®Extracell BMC

Class IIb CE certified
Medical Devices

What is Regenkit® Extracell BMC ?

What

product
  • The Flexible & Reproducible Bone Marrow Concentrate System
  • Class IIb CE certified Medical Devices
RegenTHT Tube
RegenTHT Tube

Properties

Bone marrow aspirate vol per tube
Bone marrow aspirate vol per tube

4 to 10 ml

MNC recovery
MNC recovery

> 70%

MSC recovery
MSC recovery

> 80%

CFU -F recovery per ml of BMA from the ILIAC CREST
CFU -F recovery per ml of BMA from the ILIAC CREST

– 1000

Bone Marrow Concentrate preparation with RegenKit Extracell BMC

Bone marrow concentrate (bmc) is an autologous cell concentrate from bone marrow aspirate.
Bone marrow is a liquid tissue rich in a heterogeneous population of mature cells and multipotent stem cells.
Among them, the mesenchymal stromal cells (MSC) are the musculoskeletal tissue precursor cells.

RegenKit Extracell BMC kits are specifically designed for the effective processing of bone marrow aspirate (BMA) by a short centrifugation in RegenTHT tubes. These tubes contain a biologically inert separating gel with a specific density that physically separates the plasma and the mononuclear cell (MNC) fraction, which contains the MSC, from the other bone marrow cellular elements.

More than 80% of the MSC are recovered in the resulting cell concentrate1. In vitro, these cells give rise to fibroblast colony-forming units (CFU-F) capable of undergoing osteogenesis, chondrogenesis and adipogenesis when cultured in their respective specific induction medium1.

product

Example of a procedure: Bone marrow was processed with the four tubes of the Regenkit Extracell BMC.
The resulting BMC will be combined with RegenPRP and ATS prepared from the venous blood of the patients with the tubes from the RegenKit Surgery.

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Regenkit A PRP
Regenkit A PRP

BMC prepared with RegenKit® Extracell from a small volume of bone marrow aspirate (max 40 ml) have been used successfully for complex bone healing problems such as:

  • Nonunion (Pseudarthrosis)2-3
  • Osteonecrosis (Avascular necrosis of the hip)4-5
  • Bone cysts and large bone loss (after bone tumor removal or trauma)6-8

Complete healing was obtained for around 80% of the lesions1-7

BMC are used alone3, 8, or in combination with bone grafts or synthetic osteoconductive scaffolds4-8.

BMC can also be combined with platelet-rich plasma (RegenPRP) and autologous thrombin serum (ATS) prepared with RegenKit® Surgery to obtain a gel.

Bone substitute or morselized allograft can also be added to this combination to make a bone putty 9.

Intended use of the device

Preparation of autologous bone marrow cell concentrate
Preparation of Autologous Platelet Rich Plasma & other plasma-derived products

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ce 2797

RegenKit® Extracell BMC

1 Trocar
4 RegenTHT tubes
2 Transfer devices
4 Transfer needles
1 x 80 mm transfer cannula
Self-adhesive discs

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ce 2797

RegenKit® Extracell BMC 2

1 Trocar
2 RegenTHT tubes
2 Transfer devices
2 Transfer needles
1 x 80 mm transfer cannula
Self-adhesive discs

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ce 2797

RegenKit® Surgery

1 Safety–LokTM Butterfly needle
1 Collection holder
2 RegenTHT tubes
1 RegenATS tube
1 x 1 ml Luer-LokTM syringe
1 x 5 ml Luer-LokTM syringe
1 Transfer device
2 Transfer needles
2 x 80 mm transfer cannulas
Self-adhesive discs

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ce 2797

RegenSpray Applicator

RegenSpray Applicator
1 x 10 ml Luer-LokTM syringe
1 Nozzle for spray application
1 Double piston stopper
1 Applicator syringe holder
1 x 3 ml Luer-LokTM syringe
1 3:10 ratio adapter
1 Luer-lock connector (FM)
1 x 80 mm transfer cannula
1 Transfer needle

Class IIb CE certified Medical Devices. Regen Lab SA is an ISO13485 :2016 and MDSAP certified medical device manufacturer

Warnings and precautions

This kit is intended only for bone reconstruction, orthopedic and traumatological surgeries.

A strict aseptic technique must be followed during bone marrow aspirate. Use proper safety precautions to avoid contact with patient blood or cross-contamination. Use proper safety precautions to guard against needles or broken tubes. Do not use sterile component of this kit if package is opened or damaged. Do not use components of this kit if they are broken or present a defect. Do not use the tube if it lost vacuum. Do not use the sodium citrate solution or other tube components alone. Store between 5ºC and 30ºC; bring kit to ambient temperature before using the tubes. Do not re-sterilise, do not use after the expiry date. Single use device, do not reuse any part of the kit. Reuse may lead to infection or other illness / injury. The reuse of trocar can cause the loss of mechanical properties and invalidate trocar functionality. Transfer needles must be used to transfer liquids or prepare injections, they must not be used for injection. The preparation of the bone marrow concentrate must be performed by a physician trained on the equipment and procedure, or under the supervision of the physician. The treatment with bone marrow concentrate must be performed by a qualified physician. The doctor is responsible for the proper procedure and techniques to be used with the device. The patient must be informed of the general risks associated with the treatment and of possible adverse effects.

The bone marrow concentrate must be prepared from fresh blood and must be used within four hours (extemporaneous use only). Discard each tube and any other components after use, using the method of elimination for potentially contaminated blood products. Use a horizontal head (swinging bucket) centrifuge or a fixed angle head centrifuge. Follow manufacturer instructions when using centrifuge. Excessive centrifugation force (over 2200 RCF) may cause tube breakage, exposure to blood, and possible injury. Tubes should be centrifuged, as recommended in the instructions for use, at 1500 RCF. Lower centrifugal force (below 1500 RCF) may lead to incorrect blood separation. Centrifuge carriers and inserts should be of the size specific for the tubes. Use of carriers too large or too small for the tube may result in breakage. Care should be taken to ensure that tubes are properly seated in the centrifuge cup. Tubes must be balanced in the centrifuge head to minimize the possibility of glass breakage.

Possible adverse effects

Haemorrhage, hematoma, delayed wound healing. Early or late operative infection. Persistent pain, seromas. Allergic reaction to anaesthesia.

Patented by Regen Lab SA
Platelet Rich Plasma

U.S. patent US8529957
European patent EP2073862B
Swiss patent CH696752

All our Patent

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