mCELL™ is a bone marrow-derived mesenchymal stromal cell (BM-MSC) product manufactured by TAVRA Biosciences for localized orthopedic, sports medicine, pain management, and wound-related clinical use. It is produced in an FDA-registered, cGMP facility, cryopreserved for off-the-shelf use, and supplied exclusively to licensed physicians. Each vial contains 30 million viable cells and ships with a Certificate of Analysis confirming sterility, identity, and viable cell count.
Bone marrow-derived MSCs are the most extensively studied cell type in orthopedic stem cell therapy and musculoskeletal research, with the deepest body of published clinical literature behind them. In standardized laboratory testing, BM-MSCs demonstrated approximately four times greater immunomodulatory activity than umbilical cord-derived MSCs, along with significantly higher levels of growth factors studied in connection with tissue repair and vascular signaling.
Additionally, orthopedic practice has long relied on techniques such as microfracture and subchondral drilling to access bone marrow and stimulate localized biologic activity at sites of injury. This reflects a well-established clinical understanding: bone marrow-derived cells play a defined role in adult tissue maintenance and repair, particularly in joint and connective-tissue environments subject to mechanical load. This biological rationale underpins TAVRA’s deliberate focus on bone marrow-derived cells for localized clinical use. mCELL™ delivers that same bone marrow biology in a defined, off-the-shelf format, without requiring aspiration or on-site processing.
Importantly, the only FDA-approved MSC product to date, is also a bone marrow-derived MSC product from young healthy donors — the same biological foundation as mCELL™.
Each vial of mCELL™ contains 30 million viable cells. This dose is calibrated based on published meta-analyses of randomized controlled trials evaluating intra-articular MSC therapy, which consistently identify doses at or below 25–30 million cells as the tier associated with statistically significant clinical improvement at 12 months.
Importantly, higher doses have not been shown to produce additional benefit. Excess cell concentrations can actually increase competition for local nutrients, potentially reducing efficacy. TAVRA’s 30 million cell dose is positioned at the clinically supported optimum, not more, not less. Every batch is independently lot-tested for viable cell count prior to release.
PRP (platelet-rich plasma) is drawn from the patient’s own blood and depends heavily on individual platelet concentration and biology, making results variable from patient to patient. BMAC (bone marrow aspirate concentrate) requires an invasive bone marrow aspiration procedure, in-clinic centrifugation, and point-of-care processing, with no standardized cell count and no documentation available in advance.
mCELL™ is a centrally manufactured, ready to use off-the-shelf product with a defined viable cell count, independent quality release, and lot-level documentation provided to the physician before use. No aspiration procedure. No on-site processing. No same-day centrifugation. Physicians know exactly what is in each vial before it is administered.
Published peer-reviewed studies evaluating locally administered BM-MSCs in orthopedic settings report favorable safety profiles and signals of improvement in validated pain and functional outcomes. A 2023 Phase 3 randomized controlled trial found a 45.6% improvement in WOMAC scores at 12 months in knee osteoarthritis patients, with MRI showing cartilage preservation versus worsening in the placebo group. A long-term prospective study found BM-MSC augmentation of rotator cuff repair was associated with 87% structural integrity at 10 years, compared to 44% in controls. Recent meta-analyses of randomized controlled trials identify doses at or below 30 million cells as the threshold associated with statistically significant clinical improvement, which informed TAVRA’s formulation.
Yes. Florida SB 1768, which took effect July 1, 2025, explicitly authorizes licensed physicians to perform non-FDA-approved stem cell therapy within orthopedics, pain management, and wound care, provided that specific manufacturing, sourcing, and documentation requirements are met. mCELL™ is manufactured in an FDA-registered, cGMP compliant facility, contains viable living BM-MSCs, and is intended exclusively for localized clinical use. TAVRA’s product and documentation are designed to meet and exceed what the statute requires.
Physicians must still provide patients with the required written notice, display the required statutory advertising language, and obtain signed informed consent before treatment. TAVRA provides documentation support for practices setting up compliant workflows.
The statute sets a floor, not a ceiling. Meeting the minimum legal requirements is necessary but does not distinguish one product from another. What separates mCELL™ is the documentation physicians actually receive: a lot-specific COA with a defined viable cell count, sterility testing results, donor screening confirmation, and predefined release criteria. Many products on the market provide little or none of this.
Before performing stem cell therapy under Florida SB 1768, physicians must: (1) provide the required written patient notice that the therapy is not FDA-approved; (2) include the following required language verbatim in any form of advertisement: “THIS NOTICE MUST BE PROVIDED TO YOU UNDER FLORIDA LAW. This physician performs one or more stem cell therapies that have not yet been approved by the United States Food and Drug Administration. You are encouraged to consult with your primary care provider before undergoing any stem cell therapy.”; (3) obtain a signed informed consent form disclosing the nature of the treatment, FDA approval status, anticipated results, alternative treatments, and recognized risks. Products must be administered locally only.
TAVRA provides template documentation for each of these requirements. Contact us at contact@tavrabiosciences.com to request the compliance documentation package.
mCELL™ is designed to integrate into any practice that already performs intra-articular injections. No new equipment is required. No processing staff. No additional clinical training program. The physician receives a cryopreserved vial, follows TAVRA’s thaw protocol, and proceeds to injection. The entire procedure time is the injection itself.
mCELL™ is cryopreserved and shipped in a qualified dry ice package designed to maintain viability, cell count, and sterility during transport. TAVRA provides thawing instructions to the clinical site in advance of injection. No on-site cell processing, manipulation, or centrifugation is required.
Every mCELL™ shipment includes a Certificate of Analysis documenting the viable cell count, sterility testing results confirming absence of microbial contamination, donor eligibility and infectious disease screening confirmation, and lot release status against predefined acceptance criteria. This level of documentation exceeds what Florida law requires and is designed to support physician due diligence and clear records at the point of care.
mCELL™ is intended for localized use in orthopedic, sports medicine, pain management, and wound-related clinical settings. Common applications include knee, hip, shoulder, and ankle osteoarthritis; rotator cuff and tendon injuries; partial ligament tears; chronic joint pain; and post-injury or post-surgical recovery support. Clinical use is determined by the treating physician based on the individual patient’s diagnosis, history, and treatment goals. TAVRA does not provide medical advice or patient consultations.
Stem cell therapy for orthopedic conditions is not covered by insurance because it is not FDA-approved. However, patients can use their Health Savings Account (HSA) or Flexible Spending Account (FSA) funds for stem cell therapy when treatment is for a diagnosed medical condition, such as knee osteoarthritis or a tendon injury.
The key requirement is a Letter of Medical Necessity from the treating physician, which should include the patient’s diagnosis with ICD-10 code, a statement that treatment is medically appropriate, confirmation the treatment is not for cosmetic or wellness purposes, and a disclosure that the product is not FDA-approved.
The 2026 HSA contribution limit is $4,400 for individual coverage and $8,750 for family coverage, with an additional $1,000 catch-up contribution for account holders aged 55 and older. The 2026 FSA limit is $3,400 per year. Patients should verify requirements with their individual HSA or FSA administrator, as plan rules vary.
TAVRA provides a ready-to-use LMN template and HSA/FSA patient reference document. Both are available to physicians upon request at contact@tavrabiosciences.com.
Patients should confirm eligibility with their HSA/FSA administrator before treatment.
TAVRA supplies mCELL™ exclusively to licensed physicians. To request product information, documentation, or to buy mesenchymal stem cells, contact us at contact@tavrabiosciences.com. We can also provide support for practices setting up compliant workflows under Florida SB 1768, including documentation templates and physician reference materials on dosing, HSA/FSA, and product specifications.
Before Florida’s SB 1768, the regenerative medicine market operated without enforceable standards around cell source, manufacturing quality, or documentation. Lower-cost products like exosomes, amniotic preparations, and cord blood derivatives dominated because there was no framework distinguishing them from a more rigorously manufactured alternative. Suppliers had little incentive to invest in the infrastructure required to produce a well-characterized, living-cell off-the-shelf BM-MSC product, and physicians had no clear basis for evaluating one product against another.
SB 1768 changed that. By requiring viable cells, accredited manufacturing, and documented quality standards, the law excluded the majority of what previously dominated this space and created a defined pathway for products built to an institutional standard of care. Bone marrow MSCs are not new. They are the most studied MSC type in orthopedic research and the only MSC lineage with an FDA-approved therapeutic precedent. What is new is a legal framework that makes it possible to bring a consistently manufactured, fully documented, living-cell BM-MSC product to your practice, with the quality assurance and traceability that responsible clinical use requires.
