Donum Health

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We are a patient-sourced cell therapy and regenerative medicine company focused on safe, effective, and affordable treatments.

Copyright 2024. All Rights Reserved.

Project Zero: Osteoarthritis Treatment Platform Innovation

To optimize the US healthcare system (and especially any government payer system) in the near term we need disruptive innovations that are safe, effective, and affordable, so that we can drive significant return to both patients and healthcare payers.
Patient-sourced natural cell-based therapies such as autologous bone marrow derived stem cell (BMSC) therapy and platelet rich plasma (PRP) therapies have evidence that they provide:

Key Advantages

  • A safe treatment option with lower adverse events than conventional pharmaceutical and surgical treatments. Citations 1-4
  • A rapid and durable relief of pain in as quick as 6 weeks. Citations 5-27
  • An efficient procedure completed in under 20 minutes with less than 5 simple steps and minimal equipment. Citations 28-31
  • A treatment which has superior patient satisfaction preferred over traditional treatments. Citations 32-39
  • A cost effective treatment capable of saving over $100 billion dollars in treating knee Osteoarthritis. Citations 40-42

The use of autologous cell therapy allows physicians or extenders to process and deliver the patient’s own cells from areas of high concentration to areas of low concentration with a simple, safe, and time tested process which has been vetted and permitted by the FDA, HHS and multiple bioethical organizations Citations 43-46.

The use of the patient’s own cells returns the concept of sovereignty back to the patient rather than a multinational pharmaceutical company. Consequently, there is no concern about shortages, price gouging or recalls as the patient manufactures their own treatment and controls their own destiny.

The use of BMSC and PRP can provide immediate, measurable improvements which can be published with proven results in just a few months, allowing the American public to see real results in a short period of time with significant cost savings to the average taxpayer.

The costs of these studies would also be a fraction of the costs of conventional pharmaceutical treatments and they could all be conducted through an ethical Internal Review Board.

How We're Accelerating This Approach

To expedite this process of meaningful and measurable innovation, we are leveraging the following:

  • A clinical study outline that is already completed and has been IRB approved.
  • A 3-part platform under development that enhances the efficacy of the patient-provided stem cells, that simplifies the harvesting and delivery process for HCPs, and that helps accurately dose the stem cell delivery.
  • Our commitment to the osteopathic principle that the body has an innate ability to heal itself with the cells God placed there Citations 47-48.
  • Our desire to prove that the best medical treatments are those which can be found within our own bodies.

Medical, Scientific, and Other References

Below are the key references cited above, for further review.

Safety References

  1. Safety of Cell Therapy with Mesenchymal Stromal Cells (SafeCell): A Systematic Review and Meta-Analysis of Clinical Trials. Lalu MM, McIntyre L, Pugliese C, Fergusson D, Winston BW, Marshall JC, Granton J, Stewart DJ, Canadian Critical Care Trials Group. PLoS ONE. 2012 Oct 25; 7(10): e47559 PMC [article] PMCID: PMC3485008 PMID: 23133515 DOI: 10.1371/journal.pone.0047559
  2. Cancer risk is not increased in patients treated for orthopaedic diseases with autologous bone marrow cell concentrate. Hernigou P, Homma Y, Flouzat-Lachaniette CH, Poignard A, Chevallier N, Rouard H. J Bone Joint Surg Am. 2013 Dec 18;95(24):2215-21. doi: 10.2106/JBJS.M.00261. PubMed [citation] PMID:24352775.
  3. Centeno CJ, Al-Sayegh H, Freeman MD, Smith J, Murrell WD, Bubnov R. A multi-center analysis of adverse events among two thousand, three hundred and seventy two adult patients undergoing adult autologous stem cell therapy for orthopaedic conditions. Int Orthop. 2016 Aug;40(8):1755-1765. doi: 10.1007/s00264-016-3162-y. Epub 2016 Mar 30. Erratum in: Int Orthop. 2018 Jan;42(1):223. doi: 10.1007/s00264-017-3680-2. PMID: 27026621.
  4. Centeno CJ, Schultz JR, Cheever M, Freeman M, Faulkner S, Robinson B, Hanson R. Safety and complications reporting update on the re-implantation of culture-expanded mesenchymal stem cells using autologous platelet lysate technique. Curr Stem Cell Res Ther. 2011 Dec;6(4):368-78. doi: 10.2174/157488811797904371. PMID: 22023622.

Relief of Pain

  1. Autologous conditioned serum for the treatment of osteoarthritis and other possible applications in musculoskeletal disorders. Frizziero A, Giannotti E, Oliva F, Masiero S, Maffulli N. Br Med Bull. 2013;105:169-84. doi: 10.1093/bmb/lds016. Epub 2012 Jul 4. Review. PubMed [citation] PMID:22763153
  2. Avoidance of Total Knee Arthroplasty in Early Osteoarthritis of the Knee with Intra-Articular Implantation of Autologous Activated Peripheral Blood Stem Cells versus Hyaluronic Acid: A Randomized Controlled Trial with Differential Effects of Growth Factor Addition. Turajane T, Chaveewanakorn U, Fongsarun W, Aojanepong J, Papadopoulos KI. Stem Cells International. 2017 Sep 19; 2017: 8925132 PMC [article] PMCID: PMC5625803, PMID: 29056974, DOI: 10.1155/2017/8925132
  3. Biological treatment of the knee with platelet-rich plasma or bone marrow aspirate concentrates: A review of the current status. Moatshe G, Morris ER, Cinque ME, Pascual-Garrido C, Chahla J, Engebretsen L, Laprade RF. Acta Orthopaedica. 2017 Aug 23; 88(6): 670-674 PMC [article] PMCID: PMC5694813, PMID: 28831830, DOI: 10.1080/17453674.2017.1368899
  4. Garay-Mendoza D, Villarreal-Martínez L, Garza-Bedolla A, Pérez-Garza DM, Acosta-Olivo C, Vilchez-Cavazos F, Diaz-Hutchinson C, Gómez-Almaguer D, Jaime-Pérez JC, Mancías-Guerra C. The effect of intra-articular injection of autologous bone marrow stem cells on pain and knee function in patients with osteoarthritis. Int J Rheum Dis. 2018 Jan;21(1):140-147. doi: 10.1111/1756-185X.13139. Epub 2017 Jul 27. PubMed [citation] PMID: 28752679
  5. Centeno CJ, Al-Sayegh H, Bashir J, Goodyear S, Freeman MD. A dose response analysis of a specific bone marrow concentrate treatment protocol for knee osteoarthritis. BMC Musculoskelet Disord. 2015 Sep 18;16:258. doi: 10.1186/s12891-015-0714-z. PMID: 26385099; PMCID: PMC4575428.
  6. Vega A, Martín-Ferrero MA, Del Canto F, Alberca M, García V, Munar A, Orozco L, Soler R, Fuertes JJ, Huguet M, Sánchez A, García-Sancho J. Treatment of Knee Osteoarthritis With Allogeneic Bone Marrow Mesenchymal Stem Cells: A Randomized Controlled Trial. Transplantation. 2015 Aug;99(8):1681-90. doi: 10.1097/TP.0000000000000678. PMID: 25822648.
  7. Nejadnik H, Hui JH, Feng Choong EP, Tai BC, Lee EH. Autologous bone marrow-derived mesenchymal stem cells versus autologous chondrocyte implantation: an observational cohort study. Am J Sports Med. 2010 Jun;38(6):1110-6. doi: 10.1177/0363546509359067. Epub 2010 Apr 14. PMID: 20392971.
  8. Frisbie DD, Kisiday JD, Kawcak CE, Werpy NM, McIlwraith CW. Evaluation of adipose-derived stromal vascular fraction or bone marrow-derived mesenchymal stem cells for treatment of osteoarthritis. J Orthop Res. 2009 Dec;27(12):1675-80. doi: 10.1002/jor.20933. PMID: 19544397.
  9. Vega A, Martín-Ferrero MA, Del Canto F, Alberca M, García V, Munar A, Orozco L, Soler R, Fuertes JJ, Huguet M, Sánchez A, García-Sancho J. Treatment of Knee Osteoarthritis With Allogeneic Bone Marrow Mesenchymal Stem Cells: A Randomized Controlled Trial. Transplantation. 2015 Aug;99(8):1681-90. doi: 10.1097/TP.0000000000000678. PMID: 25822648.
  10. Lee KB, Wang VT, Chan YH, Hui JH. A novel, minimally-invasive technique of cartilage repair in the human knee using arthroscopic microfracture and injections of mesenchymal stem cells and hyaluronic acid--a prospective comparative study on safety and short-term efficacy. Ann Acad Med Singap. 2012 Nov;41(11):511-7. PMID: 23235728.
  11. Kim JD, Lee GW, Jung GH, Kim CK, Kim T, Park JH, Cha SS, You YB. Clinical outcome of autologous bone marrow aspirates concentrate (BMAC) injection in degenerative arthritis of the knee. Eur J Orthop Surg Traumatol. 2014 Dec;24(8):1505-11. doi: 10.1007/s00590-013-1393-9. Epub 2014 Jan 8. PMID: 24398701.
  12. Emadedin M, Ghorbani Liastani M, Fazeli R, Mohseni F, Moghadasali R, Mardpour S, Hosseini SE, Niknejadi M, Moeininia F, Aghahossein Fanni A, Baghban Eslaminejhad R, Vosough Dizaji A, Labibzadeh N, Mirazimi Bafghi A, Baharvand H, Aghdami N. Long-Term Follow-up of Intra-articular Injection of Autologous Mesenchymal Stem Cells in Patients with Knee, Ankle, or Hip Osteoarthritis. Arch Iran Med. 2015 Jun;18(6):336-44. PMID: 26058927.
  13. Chahla J, Dean CS, Moatshe G, Pascual-Garrido C, Serra Cruz R, LaPrade RF. Concentrated Bone Marrow Aspirate for the Treatment of Chondral Injuries and Osteoarthritis of the Knee: A Systematic Review of Outcomes. Orthop J Sports Med. 2016 Jan 13;4(1):2325967115625481. doi: 10.1177/2325967115625481. PMID: 26798765; PMCID: PMC4714134.
  14. Wiggers TG, Winters M, Van den Boom NA, Haisma HJ, Moen MH. Autologous stem cell therapy in knee osteoarthritis: a systematic review of randomised controlled trials. Br J Sports Med. 2021 Oct;55(20):1161-1169. doi: 10.1136/bjsports-2020-103671. Epub 2021 May 26. PMID: 34039582.
  15. Doyle EC, Wragg NM, Wilson SL. Intraarticular injection of bone marrow-derived mesenchymal stem cells enhances regeneration in knee osteoarthritis. Knee Surg Sports Traumatol Arthrosc. 2020 Dec;28(12):3827-3842. doi: 10.1007/s00167-020-05859-z. Epub 2020 Jan 31. PMID: 32006075; PMCID: PMC7669782
  16. Lamo-Espinosa JM, Prósper F, Blanco JF, Sánchez-Guijo F, Alberca M, García V, González-Vallinas M, García-Sancho J. Long-term efficacy of autologous bone marrow mesenchymal stromal cells for treatment of knee osteoarthritis. J Transl Med. 2021 Dec 11;19(1):506. doi: 10.1186/s12967-021-03160-2. PMID: 34895259; PMCID: PMC8666077.
  17. Chen X, Zheng J, Yin L, Li Y, Liu H. Transplantation of three mesenchymal stem cells for knee osteoarthritis, which cell and type are more beneficial? a systematic review and network meta-analysis. J Orthop Surg Res. 2024 Jun 20;19(1):366. doi: 10.1186/s13018-024-04846-1. PMID: 38902778; PMCID: PMC11188250.
  18. Mardones R, Jofré CM, Tobar L, Minguell JJ. Mesenchymal stem cell therapy in the treatment of hip osteoarthritis. J Hip Preserv Surg. 2017 Mar 19;4(2):159-163. doi: 10.1093/jhps/hnx011. PMID: 28630737; PMCID: PMC5467400.
  19. Prodromos C, Rumschlag T. Administration of Autologous Mesenchymal Cells for the Treatment of Arthritis. Curr Stem Cell Res Ther. 2021;16(8):931-938. doi: 10.2174/1574888X16666210224145104. PMID: 33655846.
  20. Xie RH, Gong SG, Song J, Wu PP, Hu WL. Effect of mesenchymal stromal cells transplantation on the outcomes of patients with knee osteoarthritis: A systematic review and meta-analysis. J Orthop Res. 2024 Apr;42(4):753-768. doi: 10.1002/jor.25724. Epub 2023 Nov 22. PMID: 37991925.
  21. Shadmanfar S, Labibzadeh N, Emadedin M, Jaroughi N, Azimian V, Mardpour S, Kakroodi FA, Bolurieh T, Hosseini SE, Chehrazi M, Niknejadi M, Baharvand H, Gharibdoost F, Aghdami N. Intra-articular knee implantation of autologous bone marrow-derived mesenchymal stromal cells in rheumatoid arthritis patients with knee involvement: Results of a randomized, triple-blind, placebo-controlled phase 1/2 clinical trial. Cytotherapy. 2018 Apr;20(4):499-506. doi: 10.1016/j.jcyt.2017.12.009. Epub 2018 Feb 7. PMID: 29428486.
  22. Patel S, Dhillon MS, Aggarwal S, Marwaha N, Jain A. Treatment with platelet-rich plasma is more effective than placebo for knee osteoarthritis: a prospective, double-blind, randomized trial. Am J Sports Med. 2013 Feb;41(2):356-64. doi: 10.1177/0363546512471299. Epub 2013 Jan 8. PMID: 23299850.
  23. Torrero JI, Aroles F, Ferrer D. Treatment of knee chondropathy with platelet rich plasma. Preliminary results at 6 months of follow-up with only one injection. J Biol Regul Homeost Agents. 2012 Apr-Jun;26(2 Suppl 1):71S-78S. PMID: 23648201.

Efficient Procedure

  1. Jiang Y, Cai Y, Zhang W, Yin Z, Hu C, Tong T, Lu P, Zhang S, Neculai D, Tuan RS, Ouyang HW. Human Cartilage-Derived Progenitor Cells From Committed Chondrocytes for Efficient Cartilage Repair and Regeneration. Stem Cells Transl Med. 2016 Jun;5(6):733-44. doi: 10.5966/sctm.2015-0192. Epub 2016 Apr 29. PMID: 27130221; PMCID: PMC4878331.
  2. Uth K, Trifonov D. Stem cell application for osteoarthritis in the knee joint: A minireview. World J Stem Cells. 2014 Nov 26;6(5):629-36. doi: 10.4252/wjsc.v6.i5.629. PMID: 25426260; PMCID: PMC4178263.
  3. Centeno C, Pitts J, Al-Sayegh H, Freeman M. Efficacy of autologous bone marrow concentrate for knee osteoarthritis with and without adipose graft. Biomed Res Int. 2014;2014:370621. doi: 10.1155/2014/370621. Epub 2014 Sep 7. PMID: 25276781; PMCID: PMC4170694.
  4. Slide #36, The Value of Cell Therapy, a presentation by Dr. Edward Loniewski, DO. Available upon request, subject to approval.

Patient Satisfaction

  1. Hernigou P, Flouzat Lachaniette CH, Delambre J, Zilber S, Duffiet P, Chevallier N, Rouard H. Biologic augmentation of rotator cuff repair with mesenchymal stem cells during arthroscopy improves healing and prevents further tears: a case-controlled study. Int Orthop. 2014 Sep;38(9):1811-8. doi: 10.1007/s00264-014-2391-1. Epub 2014 Jun 7. PubMed [citation] PMID: 24913770
  2. Hernigou P, Auregan JC, Dubory A, Flouzat-Lachaniette CH, Chevallier N, Rouard H. Subchondral stem cell therapy versus contralateral total knee arthroplasty for osteoarthritis following secondary osteonecrosis of the knee. Int Orthop. 2018 Nov;42(11):2563-2571. doi: 10.1007/s00264-018-3916-9. Epub 2018 Mar 27. PMID: 29589086.
  3. Teitze DC et al The effects of platelet rich plasma in the treatment of large-joint osteoarthritis: a systemic review. Physiology and Sports Medicine 2014, May; 42(2) 27-37.
  4. Cerza F, Carnì S, Carcangiu A, Di Vavo I, Schiavilla V, Pecora A, De Biasi G, Ciuffreda M. Am J Sports Med. 2012 Dec;40(12):2822-7.
  5. Forogh B, Mianehsaz E, Shoaee S, Ahadi T, Raissi GR, Sajadi S. Effect of single injection of platelet-rich plasma in comparison with corticosteroid on knee osteoarthritis: a double-blind randomized clinical trial. J Sports Med Phys Fitness. 2016 Jul-Aug;56(7-8):901-8. Epub 2015 Jul 14. PMID: 26173792.
  6. Varma HS, The new avenues in the management of osteo-arthritis of knee - stem cells. Indian Med Assoc. 2010 Sep;108(9):583-
  7. Autologous bone marrow-derived mesenchymal stem cells versus autologous chondrocyte implantation: an observational cohort study. Nejadnik H., American Journal of Sports Medicine 2010 Jun;38(6):1110
  8. Hernigou P, Poignard A, Zilber S, Rouard H. Cell therapy of hip osteonecrosis with autologous bone marrow grafting. Indian J Orthop. 2009 Jan;43(1):40-5. doi: 10.4103/0019-5413.45322. PMID: 19753178; PMCID: PMC2739495.

Cost Effective

  1. Slide #43: The Value of Cell Therapy, a presentation by Dr. Edward Loniewski, DO. Available upon request, subject to approval.
  2. Bennell KL, Hunter DJ, Paterson KL. Platelet-Rich Plasma for the Management of Hip and Knee Osteoarthritis. Curr Rheumatol Rep. 2017 May;19(5):24. doi: 10.1007/s11926-017-0652-x. PMID: 28386761.
  3. Hohmann E. Editorial Commentary: Platelet-Rich Plasma and Hyaluronic Acid Injection for Knee Osteoarthritis Are Both Cost Effective. Arthroscopy. 2020 Dec;36(12):3079-3080. doi: 10.1016/j.arthro.2020.09.039. PMID: 33276894.

FDA Compliance

  1. Regulatory Considerations for Human Cells, Tissues, and Cellular and Tissue-Based Products: Minimal Manipulation and Homologous Use Guidance for Industry and Food and Drug Administration Staff. https://www.fda.gov/media/109176/download

Ethical Issues

  1. Charitos IA, Ballini A, Cantore S, Boccellino M, Di Domenico M, Borsani E, Nocini R, Di Cosola M, Santacroce L, Bottalico L. Stem Cells: A Historical Review about Biological, Religious, and Ethical Issues. Stem Cells Int. 2021 Apr 29;2021:9978837. doi: 10.1155/2021/9978837. PMID: 34012469; PMCID: PMC8105090.
  2. Volarevic V, Markovic BS, Gazdic M, Volarevic A, Jovicic N, Arsenijevic N, Armstrong L, Djonov V, Lako M, Stojkovic M. Ethical and Safety Issues of Stem Cell-Based Therapy. Int J Med Sci. 2018 Jan 1;15(1):36-45. doi: 10.7150/ijms.21666. PMID: 29333086; PMCID: PMC5765738.
  3. King, N.M., Perrin, J. Ethical issues in stem cell research and therapy. Stem Cell Res Ther 5, 85 (2014). https://doi.org/10.1186/scrt474

Osteopathic Principles and Practices

  1. Tuscano SC, Haxton J, Ciardo A, Ciullo L, Zegarra-Parodi R. The Revisions of the First Autobiography of AT Still, the Founder of Osteopathy, as a Step towards Integration in the American Healthcare System: A Comparative and Historiographic Review. Healthcare (Basel). 2024 Jan 6;12(2):130. doi: 10.3390/healthcare12020130. PMID: 38255019; PMCID: PMC10815194.
  2. Kuchera ML. Applying osteopathic principles to formulate treatment for patients with chronic pain. J Am Osteopath Assoc. 2007 Nov;107(10 Suppl 6):ES28-38. PMID: 17986675.