Therapeutic Uses of Platelets
Cambium's Aurarix™ awaiting formulation into novel regenerative therapeutics.
Platelets and platelet transfusions have traditionally been used for patients with low platelet count, in certain cancer treatments, as part of organ transplants and in certain surgeries. Additionally, the use of autologous (patient sourced) platelet-rich-plasma has been safely used and documented for numerous years in orthopedics (PRP); sports medicine, dentistry, ENT, neurosurgery, ophthalmology (serum drops for dry eye and numerous corneal diseases), urology, would healing, cosmetics, dermatology, cardiothoracic and maxillofacial surgery—to name a few.
Although basic science and preliminary research show PRP treatments to be safe and effective, most scientific studies continue to be anecdotal, non-randomized, or involve insufficient sample sizes and underpowered research methodologies. Additionally, platelet based therapies sourced and processed from individual diseased patients have remained (and Cambium believes will always remain if from patients) niche therapies and largely for failed meds patients because of several inherent limitations:
- Sourcing of base platelets from individual diseased patients (often on other systematic drugs which end up as trace contaminants in serum products) versus sourced and pooled from younger healthier pre-screened donors.
- The absence of large, multi-site, randomized, peer-reviewed, masked clinical studies.
- No FDA approvals.
- No industry acknowledged standards regarding the sourcing, collection, processing, shipping, storage and dosage of platelet based products.
- Lack of product consistency batch-to-batch even for therapies derived from platelets from the same patient.
- Inconveniences, invasiveness of having to donate own blood every 2-3 months.
- Requirement to store platelet derived products in freezer and thaw the night before (i.e., no shelf stable products).
- No GMP manufacturing.
- Finally and very important--no reimbursement due to no standardization ending up costing patients out-of-pocket as much as $600/quarter.
Cambium believes its standardized, commercialized, GMP manufactured and eventually FDA approved products using serum sourced not from older diseased patients but from younger healthier pre-screened donors--will achieve main stage status in many applications by successfully addressing the above historical limitations. Additionally, Cambium’s novel platelet process will result in platelet therapies not equivalent to their non-FDA approved counterparts, but superior in levels of certain key nutritive and regenerative components and with less/none of many trace contaminants commonly found today in patient derived platelet therapies.