Background Context: Surgical treatments of discogenic lumbar back pain are fusion or lumbar artificial disc replacement. Studies comparing lumbar fusion with nonsurgical treatment found no difference in clinical results. Studies comparing lumbar fusion with lumbar artificial disc replacement have had mixed results. In a study with 12-month follow-up, our colleagues reported that intradiscal injections of autologous bone marrow concentrated cells resulted in substantial reductions in pain and disability without treatment complications or other adverse events. Purpose: This article reports a 5-year follow-up of treating lumbar discogenic back pain and disability with bone marrow concentrate. Study Design/Setting: Prospective, open-label, single-center case series. Patient Sample: The initial 26 participants were all surgical candidates according to their history of low back pain, nonsurgical treatment, and measurements of pain, disability, and disc degeneration. Outcome Measures: Visual Analog Scale of pain, and Oswestry Disability Index. Methods: Study design and clinical protocol, bone marrow collection and processing, and intradiscal injection were as previously described in the initial report. The study did not receive any outside funding. The disposable aspiration kits for the BMC injections, which cost about $20 each, were provided without charge by Celling Biosciences, Austin, Texas. Results: Of the initial 26 participants, six proceeded to surgery within 3 years of follow up. Of the remaining 20, 19 were available for follow-up at 5 years. Absolute and percentage reductions in pain and disability scores were sustained through the 5-year follow-up. No adverse events were reported through the 5 years. Conclusions: It may be reasonable to consider injecting participants who have discogenic back pain at one or two levels with bone marrow concentrate before they proceed to surgery.

Secreted bone marrow mesenchymal stem cell derived extracellular vesicles (BM-MSC-EVs) are reported to contain hundreds of different growth factors, cytokines, chemokines, micro and messenger RNAs packaged within exosomes. This is the first report on the safety and clinical efficacy of an BM-MSC-EV product (ExoFlo™) to treat osteoarthritis (OA). Thirty-three Navy SEAL veterans were treated with ExoFlo for OA of the knee (n=58), shoulder (n=32), elbow (n=16), hip (n=12), ankle (n=8) or wrist (n=6). At six-month follow-up, the average patient improved 77% in BPI, 80% in ODI, 76% in LEFS, 51% in UEFS, and 77% in QD. All improvements were statistically significant with values of p<0.001. Ninety-five percent of the improvement occurred within the first six weeks following injection. There were no complications or adverse events, minor or major, and no patient was observed to have accelerated OA progression resultant from the ExoFlo injection. These patients will continue to be followed for at least 2-years. At six-month follow-up, a single ExoFlo injection for OA appears safe and clinically efficacious for the treatment of patients with at least grade-2 changes utilizing the Kellgren-Lawrence scale.

The patient is a 51 years old athlete with a 2 ½ yr. history of increasing left medial and patella-femoral knee pain. He had previously failed two arthroscopic procedures, a hyaluronic acid and PRP injections. MRI and arthroscopy indicated Kellgren-Lawrence grade three arthritis in the medial femoraltibial and patellofemoral areas of the knee joint. He underwent a single injection of bone marrow-derived mesenchymal stem cell EVIP (ExoFlo Direct Biologics, St. Louis MO) containing active growth factors (over 800) and exosomes (0ver 10 Billion per cc). Within two weeks he had returned to normal activities. At six-month follow-up he feels his overall improvement is 75%. His improvement at six-month follow-up in BPI was 96%, ODI 84% and LEFS 59%. There were no complications with the injection.

Diarthrodial joints, such as the knee, hip, and shoulder consist of articular cartilage, a synovial capsule, and a fibrocartilaginous structure to increase the stability of the joint.

There is increasing published literature to support the safety and efficacy of IV infusions of bone marrow-derived expanded allogeneic mesenchymal stem cells (MSCs) for the treatment of various auto-immune diseases. Frailty Syndrome was created to provide a way of objectively measuring aging with physical activity scales and bio-inflammatory markers. IV infusions of allogeneic MSCs have been reported to statistically significantly increase physical function and decrease inflammatory biomarkers in Frailty Syndrome. Replacing cellular allogeneic IV infusions with acellular bone marrow-derived MSC extracellular vesicle isolate products (EVIP) containing active growth factors (GFs) and exosomes has numerous advantages. Regenerative medicine researchers and clinicians now realize that living MSCs are not required to achieve clinical efficacy. The clinical efficacy of MSCs is due to their paracrine release of GFs and exosomes. Living MSCs are not required to accomplish the paracrinesignaling of GFs and exosomes. Acellular MSC EVIP containing active GFs and exosomes are the future of regenerative medicine.Acellular exosomesderived from bone marrow MSCs provide a consistent product that has extensive characterization, which includes advanced particle analysis, proteomic evaluation and USP<71> sterility assurance. The future “Fountain of Youth” will be the frequent (3 to 4 times per year) IV infusion of bio pharmacologic quality bone marrow-derived MSC EVIP. These active GF and exosome infusions will result in a continual down regulation of systemic inflammation and based on published research reverse many of the inflammatory effects of aging.

Cadaver and radiographic studies have demonstrated shoulder osteoarthritis (OA) in up to 33% of patients over the age of 60. Patients that present with shoulder OA have pain, crepitus and loss of glenohumeral motion. Limiting the ability to place your hand where you desire severely impairs activities of daily living. The nonsurgical treatments for shoulder OA, include shoulder exercises, the use of analgesics and non-steroidal anti-inflammatory medications. If these non-surgical treatments fail to relieve the OA impairment, the surgical treatment is total shoulder arthroplasty (TSA).

Objective: This is the first report on the safety and clinical efficacy of a bone marrow mesenchymal cell extracellular vesicle isolate product (XoFlo™) to treat osteoarthritis (OA). Design, Setting, and Methods: Thirty-three Navy SEAL veterans were treated with XoFlo for OA of the knee (n=58), shoulder (n=32), elbow (n=16), hip (n=12), ankle (n=8) or wrist (n=6). Four Pain and Motion Indexes were used to evaluate patients' OA. Results: At 1-year follow-up, the average patient improved 82% in BPI, 77% in ODI, 67% in LEFS, 50% in UEFS, and 77% in QD. All improvements were statistically significant with values of p<0.001. Ninety-five percent of the improvement occurred within the first six weeks following the injection and continued through the 1-year follow-up. There were no complications or adverse events, minor or major. No patient was observed to have accelerated OA progression or made clinically worse from the XoFlo injection. Conclusions: At 1-year follow-up, a 2cc injection per joint of XoFlo appears to be safe and clinically efficacious for the treatment of patients with at least Grade 2 changes of OA utilizing the Kellgren-Lawrence scale. These patients will continue to be followed for at least two years.

Objective: Millions of patients suffer chronic back pain from degenerated lumbar discs. Surgical options for one or two levels of discogenic back pain are fusion or lumbar artificial disc replacement [LADR]. Study Design: This study compares the complications, reoperations, cost, and clinical outcomes of bone marrow concentrate [BMC] versus LADR for the treatment of discogenic back pain. The BMC study is prospective non-randomized class 2 data. The LADR studies were prospective randomized class 1 data. All operations were performed at the same private clinic. All studies had IRB approval. Follow up on all the studies was two years. Methods: The BMC was a 30-minute procedure involving aspiration of 55ml of bone marrow from the iliac wing, concentrating via centrifugation to a volume of 6ml and then injecting approximately 2ml of bone marrow concentrate per symptomatic lumbar disc. Clinical success in the LADR and BMC studies required a 50% improvement in ODI and VAS from pre-operative through two-year follow-up. Results: Clinical failure of LADR occurred in 27% (24 of 89 patients) at two-year follow-up. Five patients in the BMC study had surgery within two years of the BMC injection and were considered failures (19%). The remaining 21 BMC patients improved an average of 64% in ODI and 72% in VAS. Conclusions: These results indicate a BMC injection may be a reasonable non-surgical option for patients with symptomatic discogenic back pain.