ConCelltrate® 100 is derived from 100% human allograft bone.
ConCelltrate® 100 has been histologically proven to contain all 5 elements of bone formation including new bone, bone marrow, osteocytes, chondrocytes, and cartilage in the athymic rat post-implantation at 28 days. In-vivo testing is performed by an independent laboratory on every lot post-sterilization.
ConCelltrate® 100 is processed using CellRight Technologies® proprietary process. ConCelltrate® 100 may be hydrated with saline, blood, Bone Marrow Aspirate (BMA), Platelet Rich Plasma (PRP), or other cellular components in accordance with a physicians well-informed medical judgement. ConCelltrate® 100 does not contain any extrinsic carriers and is entirely derived from 100% human allograft bone. ConCelltrate® 100 is provided in a ready to use mixing jar.
ConCelltrate® 100 is provided sterile with a medical device Sterility Assurance Level (SAL) 10-6. The product should be stored in ambient temperatures and has a shelf life of five years from the date of packaging.
CellRight Technologies® employs strict quality assurance and quality control procedures to ensure patient safety. CellRight’s medical director, a licensed physician, performs an extensive medical review of the donor’s medical/social history to determine eligibility. Only donors whose screening, serologic, and microbiologic tests meet or exceed the current standards established by the Food and Drug Administration (FDA) and the American Association of Tissue Banks (AATB) are accepted for transplantation.
ConCelltrate® 100 is indicated for homologous use for the treatment of surgically created or traumatic skeletal defects.