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New Paradigm Shift in Medicine

Stem cell therapies represent a new paradigm shift in medicine, allowing doctors to primarily heal patients with like tissues as opposed to treating and masking symptoms with chemical pharmaceutical products.

Safety of Autologous Adipose Stromal Vascular Fraction (SVF)

The international medical community has shown that SVF has an incredible safety profile (see Safety Addendum). When used for cell regeneration, SVF is by definition homologous, as its stem characteristics allow the Adipose Derived Stem Cells (ADSCs) within SVF to differentiate into multiple different tissues (Symonds et al 2019). Autologous SVF isolated and returned to the patient during a same day surgical procedure does not risk rejection, and complications like GVHD are unreported unlike allogenic cell types. When SVF is isolated in a sterile surgical procedure, using a medical grade GMP collagenase enzyme, there is no manipulation of the cell and further, no risk of rejection or communicable disease transmission (Carvalho et al 2013).

Many publications have demonstrated that autologous SVF is not associated with malignancy, with numerous SVF studies showing lower incidents of cancer in their cohort than expectations in the general public (See Safety Addendum and Updated Safety Profile on 6,949 Patients).

Well Studied, Documented and Effective Therapies

SVF has been well studied both in the laboratory and clinically (see Addendum). It has shown tremendous efficacy in orthopedics, neurology, pain management, urology and autoimmune conditions. Patients are consistently realizing lasting improvement with SVF. Many of these improvements have resulted in patients avoiding invasive surgeries that involve the risk of morbidity and mortality (no such risk with SVF) and in many cases, decreased opioid use.

Condition (n) Patients Improved Condition 2 Year Improvement
Knee (3453) 82.80% 58.97%
Hip (1431) 78.90% 66.73%
Shoulder (1399) 79.00% 62.22%
Lumbar Back (998) 76.70% 46.10%
Multiple Sclerosis (311) 70.20% 52.07%

Best Practices Based on Over 11,000 Patients in Online Registry

The above data and the below safety data have all been collected under IRB approved protocols in an online HIPAA compliant database where patients are automatically queried after their SVF procedure at week 1, month 1, month 3 and every 3 months after that for out to 5 years.

The only serious adverse events reported from SVF have been from intravitreal injection. To date, 4 patients (1 from Cell Surgical Network, CSN) claim retinal detachment from the intravitreal injection of SVF which has caused such IRB protocols to be pulled. Prior, 10 of 12 patients receiving SVF via intravitreal injection for macular degeneration had reported improvement in one group of patients.

While intravitreal injections carry a 0.9% risk of retinal detachment, current studies suggest IV and subtenon injections work as well with less risk. To date, SVF has demonstrated vast safety when injected via intravenous infusion or into any soft tissue.

Updated SVF Safety Profile

Originally Demonstrated and Published (Berman, Lander et al 2017)
August 2019 – Documented and Reported Post-Procedural Adverse Events, 6,949 Total Patients

1 Week AE & SAE Questions None Mild Moderate Severe Missing Total
n (valid %) n (% of total)
Problem with Surgical Prep 6380 (91.8) 321 (4.6) 77 (1.1) 9 (0.1) 162 (2.3) 6949 (100.0)
Pain from Local Anesthetic 5294 (76.1) 1284 (18.4) 176 (2.5) 21 (0.3) 174 (2.5)
Pain from Liposuction Procedure 3197 (46.0) 2594 (37.3) 861 (12.3) 120 (1.7) 177 (2.5)
Pain at Liposuction Site after 1 week 3792 (54.5) 2261 (32.5) 568 (8.1) 43 (0.6) 285 (4.1)
Infection at Liposuction Site 6682 (96.1) 31 (0.4) 236 (3.3)
Any unusual allergic reaction to procedure 2281 (32.8) 26 (0.3) 4642 (66.8)
Pain at deployment site 4530 (65.1) 1524 (21.9) 490 (7.0) 147 (2.1) 258 (3.7)
Pain after 1 week at deployment site 5221 (75.1) 1022 (14.7) 283 (4.0) 54 (0.7) 369 (5.3)
Infection at deployment site 6612 (95.1) 35 (0.5) 302 (4.3)
Bleeding at deployment site 6379 (91.7) 287 (4.1) 26 (0.3) 5 (0.007) 252 (3.6)
Hematoma 6644 (96.6) 19 (0.2)
Infection with fever 6619 (95.2) 19 (0.2)

 

Long-Term Follow Up Questionnaire

  No Yes Missing Total
n (valid %) n (valid %)
Did you experience any adverse events that you believe are related to your stem cell therapy? 1223 (94.5) 21 (1.6) 49 (3.7) 1293 (100.0)
After your SVF procedure, have you been diagnosed with a tumor or cancer? 1178 (91.1) 29. (2.2) 86 (6.6)  

 

Addendum: Safety of SVF Publications

 Berman, Mark, and Elliot Lander. “A Prospective Safety Study of Autologous Adipose-Derived Stromal Vascular Fraction Using a Specialized Surgical Processing System.” The American Journal of Cosmetic Surgery, vol. 34, no. 3, 2017, pp. 129–142., doi:10.1177/0748806817691152.

 Duma C, Lander E, Berman M. “Human Intracerebroventricular (ICV) Injection of Autologous, Non-Engineered, Adipose-Derived Stromal Vascular Fraction (ADSVF) for Neurodegenerative Disorders: Results of a 3-Year Phase 1 Study of 113 Injections in 31 Patients.” Molecular Biology Reports, 2019, doi:10.1007/s11033-019-04983-5.

 Granel, Brigitte, et al. “Safety, Tolerability and Potential Efficacy of Injection of Autologous Adipose-Derived Stromal Vascular Fraction in the Fingers of Patients with Systemic Sclerosis: an Open-Label Phase I Trial.” Annals of the Rheumatic Diseases, vol. 74, no. 12, 2014, pp. 2175–2182., doi:10.1136/annrheumdis-2014-205681.

 Krastev, Todor, et al. “Long-Term Follow-up of Autologous Fat Transfer vs Conventional Breast Reconstruction and Association With Cancer Relapse in Patients With Breast Cancer.” JAMA Surgery, vol. 154, no. 1, 2019, p. 56., doi:10.1001/jamasurg.2018.3744.

 Lander, Elliot B. “Autologous Stromal Vascular Fraction: A New Era of Personal Cell Therapy.” Stem Cells Research, Development & Therapy, vol. 4, 2018, pp. 1–6., doi:10.24966/srdt- 2060/100011.

 Lander, Elliot B., et al. “Safety of Stromal Vascular Fraction Cells Applications in Chronic Pain.” Techniques in Regional Anesthesia and Pain Management, vol. 19, no. 1-2, 2015, pp. 10– 13., doi:10.1053/j.trap.2016.09.002.

 Michalek, Jaroslav, et al. “Stromal Vascular Fraction Cell Therapy for a Stroke Patient—Cure without Side Effects.” Brain Sciences, vol. 9, no. 3, 2019, p. 55., doi:10.3390/brainsci9030055.

 Ra, Jeong Chan, et al. “Effect of the Multiple Intravenous Administration of Cultured Human Autologous Adipose-Derived Stem Cells on Tumor Biomarker Levels.” Journal of Clinical Case Reports, vol. 7, no. 11, 2017, doi:10.4172/2165-7920.10001040.

 Rodriguez, Jorge Paz, et al. “Autologous Stromal Vascular Fraction Therapy for Rheumatoid Arthritis: Rationale and Clinical Safety.” International Archives of Medicine, vol. 5, no. 1, 2012, p. 5., doi:10.1186/1755-7682-5-5.

 Toyserkani, Navid Mohamadpour, et al. “Concise Review: A Safety Assessment of Adipose- Derived Cell Therapy in Clinical Trials: A Systematic Review of Reported Adverse Events.”

STEM CELLS Translational Medicine, vol. 6, no. 9, 2017, pp. 1786–1794., doi:10.1002/sctm.17-0031. 

Addendum: Safety of GMP Enzymatic Cell Isolation – No Manipulation

 Carvalho, Pedro P., et al. “Xenofree Enzymatic Products for the Isolation of Human Adipose- Derived Stromal/Stem Cells.” Tissue Engineering Part C: Methods, vol. 19, no. 6, 2013, pp. 473–478., doi:10.1089/ten.tec.2012.0465.

 Addendum: Additional Publications on Stromal Vascular Fraction

 “Autologous Adipose Tissue-Derived Stromal Vascular Fraction Cells Application in Patients with Osteoarthritis.” Cell Transplantation, 2015, doi:10.3727/096368915×686760.

 Bansal, Himanshu, et al. “Intra-Articular Injection in the Knee of Adipose Derived Stromal Cells (Stromal Vascular Fraction) and Platelet Rich Plasma for Osteoarthritis.” Journal of Translational Medicine, vol. 15, no. 1, 2017, doi:10.1186/s12967-017-1242-4.

 Barry, Frank. “Faculty of 1000 Evaluation for Evaluation of Adipose-Derived Stromal Vascular Fraction or Bone Marrow-Derived Mesenchymal Stem Cells for Treatment of Osteoarthritis.” F1000 – Post-Publication Peer Review of the Biomedical Literature, 2010, doi:10.3410/f.1769957.1295055.

 Berman, Sean, Berman Mark, Lander Elliot. “Effective Treatment of Traumatic Brain Injury in Rowett Nude Rats with Stromal Vascular Fraction Transplantation.” Brain Sciences, vol. 8, no. 6, 2018, p. 112., doi:10.3390/brainsci8060112.

 Bowles, Annie C., et al. “Immunomodulatory Effects of Adipose Stromal Vascular Fraction Cells Promote Alternative Activation Macrophages to Repair Tissue Damage.” Stem Cells, vol. 35, no. 10, 2017, pp. 2198–2207., doi:10.1002/stem.2689.

 Bright, Ralph, et al. “Migraine and Tension-Type Headache Treated with Stromal Vascular Fraction: a Case Series.” Journal of Medical Case Reports, vol. 8, no. 1, 2014, doi:10.1186/1752-1947-8-237.

 Chae, Dong-Sic, et al. “Stromal Vascular Fraction Shows Robust Wound Healing through High Chemotactic and Epithelialization Property.” Cytotherapy, vol. 19, no. 4, 2017, pp. 543–554., doi:10.1016/j.jcyt.2017.01.006.

 Comella, Kristin, et al. “Autologous Stromal Vascular Fraction in the Intravenous Treatment of End-Stage Chronic Obstructive Pulmonary Disease: A Phase I Trial of Safety and Tolerability.” Journal of Clinical Medicine Research, vol. 9, no. 8, 2017, pp. 701–708., doi:10.14740/jocmr3072w.

Comella, Kristin, et al. “Effects of the Intradiscal Implantation of Stromal Vascular Fraction plus Platelet Rich Plasma in Patients with Degenerative Disc Disease.” Journal of Translational Medicine, vol. 15, no. 1, 2017, doi:10.1186/s12967-016-1109-0.

 Davies, John, and Rohin Iyer. “Faculty of 1000 Evaluation for Adipose Tissue-Derived Multipotent Stromal Cells Have a Higher Immunomodulatory Capacity than Their Bone Marrow-Derived Counterparts.” F1000 – Post-Publication Peer Review of the Biomedical Literature, 2013, doi:10.3410/f.718013875.793477552.

 Domergue, Sophie, et al. “Comparison between Stromal Vascular Fraction and Adipose Mesenchymal Stem Cells in Remodeling Hypertrophic Scars.” Plos One, vol. 11, no. 5, 2016, doi:10.1371/journal.pone.0156161.

 Draganov1, Dobrin D., et al. “Delivery of Oncolytic Vaccinia Virus by Matched Allogeneic Stem Cells Overcomes Critical Innate and Adaptive Immune Barriers.” Journal of Translational Medicine, BioMed Central, 27 Mar. 2019, translational- medicine.biomedcentral.com/articles/10.1186/s12967-019-1829-z.

 Dykstra, Jordan A., et al. “Concise Review: Fat and Furious: Harnessing the Full Potential of Adipose-Derived Stromal Vascular Fraction.” STEM CELLS Translational Medicine, vol. 6, no. 4, 2017, pp. 1096–1108., doi:10.1002/sctm.16-0337.

 Gentile, Pietro, et al. “Concise Review: The Use of Adipose-Derived Stromal Vascular Fraction Cells and Platelet Rich Plasma in Regenerative Plastic Surgery.” Stem Cells, vol. 35, no. 1, 2016, pp. 117–134., doi:10.1002/stem.2498.

 Gibbs, Nathan, et al. “Management of Knee Osteoarthritis by Combined Stromal Vascular Fraction Cell Therapy, Platelet-Rich Plasma, and Musculoskeletal Exercises: a Case Series.” Journal of Pain Research, 2015, p. 799., doi:10.2147/jpr.s92090.

 Gimble, Jeffrey M., et al. “Concise Review: Adipose-Derived Stromal Vascular Fraction Cells and Stem Cells: Let’s Not Get Lost in Translation.” Stem Cells, vol. 29, no. 5, 2011, pp. 749– 754., doi:10.1002/stem.629.

 Glass, Graeme Ewan, and Patrizia Ferretti. “Adipose-Derived Stem Cells in Aesthetic Surgery.”

Aesthetic Surgery Journal, vol. 39, no. 4, 2018, pp. 423–438., doi:10.1093/asj/sjy160.

 Gumucio, Jonathan P., et al. “Stromal Vascular Stem Cell Treatment Decreases Muscle Fibrosis Following Chronic Rotator Cuff Tear.” International Orthopaedics, vol. 40, no. 4, 2015, pp. 759–764., doi:10.1007/s00264-015-2937-x.

 “Intra-Articular Transplantation of Autologous Adipose Derived Stromal Vascular Faction (SVF) for Treatment of Osteoarthritis of the Knee.” Case Medical Research, 2019, doi:10.31525/ct1-nct03940950.

Kilinc, Mehmet Okyay, Lander Elliot, Berman, Mark. “The Ratio of ADSCs to HSC-Progenitors in Adipose Tissue Derived SVF May Provide the Key to Predict the Outcome of Stem-Cell Therapy.” Clinical and Translational Medicine, vol. 7, no. 1, 2018, doi:10.1186/s40169-018-0183-8.

 Kim, Y.s., et al. “Assessment of Clinical and MRI Outcomes after Mesenchymal Stem Cell Implantation in Patients with Knee Osteoarthritis: a Prospective Study.” Osteoarthritis and Cartilage, vol. 24, no. 2, 2016, pp. 237–245., doi:10.1016/j.joca.2015.08.009.

 Lander, Elliot B, and Mark H Berman. “Autologous Stromal Vascular Fraction Containing Stem Cells Combined with Low Intensity Shock Wave for the Treatment of Human Erectile Dysfunction.” Journal of Stem Cell Research & Therapy, vol. 08, no. 09, 2018, doi:10.4172/2157-7633.1000438.

Lander, Elliot B., et al. “Stromal Vascular Fraction Combined with Shock Wave for the Treatment of Peyronie’s Disease.” Plastic and Reconstructive Surgery – Global Open, vol. 4, no. 3, 2016, doi:10.1097/gox.0000000000000622.

 Lander, Elliot, et al. “Personal Cell Therapy for Interstitial Cystitis with Autologous Stromal Vascular Fraction Stem Cells.” Therapeutic Advances in Urology, vol. 11, no. 1, ser. 9, 2019. 9, doi:10.1177/1756287219868590.

 Nguyen, Phu Dinh, et al. “Comparative Clinical Observation of Arthroscopic Microfracture in the Presence and Absence of a Stromal Vascular Fraction Injection for Osteoarthritis.” STEM CELLS Translational Medicine, vol. 6, no. 1, 2016, pp. 187–195., doi:10.5966/sctm.2016-0023.

 Pak, Jaewoo, et al. “Cartilage Regeneration in Humans with Adipose Tissue-Derived Stem Cells and Adipose Stromal Vascular Fraction Cells: Updated Status.” International Journal of Molecular Sciences, vol. 19, no. 7, 2018, p. 2146., doi:10.3390/ijms19072146.

 Pak, Jaewoo, et al. “Complete Resolution of Avascular Necrosis of the Human Femoral Head Treated with Adipose Tissue-Derived Stem Cells and Platelet-Rich Plasma.” Journal of International Medical Research, vol. 42, no. 6, 2014, pp. 1353–1362., doi:10.1177/0300060514546940.

 Pak, Jaewoo, et al. “Current Use of Autologous Adipose Tissue-Derived Stromal Vascular Fraction Cells for Orthopedic Applications.” Journal of Biomedical Science, vol. 24, no. 1, 2017, doi:10.1186/s12929-017-0318-z.

 Pak, Jaewoo, et al. “Regeneration of Cartilage in Human Knee Osteoarthritis with Autologous Adipose Tissue-Derived Stem Cells and Autologous Extracellular Matrix.” BioResearch Open Access, vol. 5, no. 1, 2016, pp. 192–200., doi:10.1089/biores.2016.0024.

Paliwal, Swati, et al. “Regenerative Abilities of Mesenchymal Stem Cells through Mitochondrial Transfer.” Journal of Biomedical Science, vol. 25, no. 1, 2018, doi:10.1186/s12929-018- 0429-1.

 Pham, Phuc Van, et al. “Transplantation of Nonexpanded Adipose Stromal Vascular Fraction and Platelet-Rich Plasma for Articular Cartilage Injury Treatment in Mice Model.” Journal of Medical Engineering, vol. 2013, 2013, pp. 1–7., doi:10.1155/2013/832396.

 Riordan, Neil H, et al. “Non-Expanded Adipose Stromal Vascular Fraction Cell Therapy for Multiple Sclerosis.” Journal of Translational Medicine, vol. 7, no. 1, 2009, p. 29., doi:10.1186/1479-5876-7-29.

 Saxer, Franziska, et al. “Implantation of Stromal Vascular Fraction Progenitors at Bone Fracture Sites: From a Rat Model to a First-in-Man Study.” Stem Cells, vol. 34, no. 12, 2016, pp. 2956–2966., doi:10.1002/stem.2478.

 Semon, Julie A, et al. “Comparison of Human Adult Stem Cells from Adipose Tissue and Bone Marrow in the Treatment of Experimental Autoimmune Encephalomyelitis.” Stem Cell Research & Therapy, vol. 5, no. 1, 2014, p. 2., doi:10.1186/scrt391.

 Siennicka, Katarzyna, et al. “Adipose-Derived Cells (Stromal Vascular Fraction) Transplanted for Orthopedical or Neurological Purposes: Are They Safe Enough?” Stem Cells International, vol. 2016, 2016, pp. 1–5., doi:10.1155/2016/5762916.

 Sierra, Rafael, et al. “Mesenchymal Stem Cell Therapy for Osteoarthritis: Current Perspectives.” Stem Cells and Cloning: Advances and Applications, 2015, p. 117., doi:10.2147/sccaa.s68073.

 Strioga, Marius, et al. “Same or Not the Same? Comparison of Adipose Tissue-Derived Versus Bone Marrow-Derived Mesenchymal Stem and Stromal Cells.” Stem Cells and Development, vol. 21, no. 14, 2012, pp. 2724–2752., doi:10.1089/scd.2011.0722.

 Symonds, Michael. “Identification of a Mesenchymal Progenitor Cell Hierarchy in Adipose Tissue.” F1000 – Post-Publication Peer Review of the Biomedical Literature, 2019, doi:10.3410/f.735618259.793559500.

 Tsuji, Wakako. “Adipose-Derived Stem Cells: Implications in Tissue Regeneration.” World Journal of Stem Cells, vol. 6, no. 3, 2014, p. 312., doi:10.4252/wjsc.v6.i3.312.

 Usuelli, Federico Giuseppe, et al. “Intratendinous Adipose-Derived Stromal Vascular Fraction (SVF) Injection Provides a Safe, Efficacious Treatment for Achilles Tendinopathy: Results of a Randomized Controlled Clinical Trial at a 6-Month Follow-Up.” Knee Surgery, Sports Traumatology, Arthroscopy, vol. 26, no. 7, 2017, pp. 2000–2010., doi:10.1007/s00167-017-4479-9.

Yokota, Naomasa, et al. “Clinical Results Following Intra-Articular Injection of Adipose-Derived Stromal Vascular Fraction Cells in Patients with Osteoarthritis of the Knee.” Regenerative Therapy, vol. 6, 2017, pp. 108–112., doi:10.1016/j.reth.2017.04.002.

 You, Dalsan, et al. “Comparative Study of Autologous Stromal Vascular Fraction and Adipose- Derived Stem Cells for Erectile Function Recovery in a Rat Model of Cavernous Nerve Injury.” STEM CELLS Translational Medicine, vol. 4, no. 4, 2015, pp. 351–358.,

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