Current And Potential Uses

Current and potential uses

Human placental tissue allografts: wound care & surgical applications

Human placental tissue allografts have been or are being investigated for the treatment of numerous types of skin conditions and wounds and for use with many surgical procedures, such as:

 

Note: this list is not exhaustive, it is meant as an example of the clinical trials using amnion/placenta/umbilical allografts

Regulation: Placental tissue allografts are highly regulated by the FDA as human cell, tissue, and cellular and tissue-based products (HCT/Ps) as defined in 21 CFR Part 1271 and Section 361 of the Public Health Services Act, and they are designed for use as covers, wraps or barriers.

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Optimized Lyopreservation

  1. Abdulhalim BEH, Wagih MM, Gad AAM, Boghdadi G, Nagy RRS. Amniotic membrane graft to conjunctival flap in treatment of non-viral resistant infectious keratitis: a randomised clinical study. Br J Ophthalmol. 2015;99(1):59–63.
  2. Anderson DG, Popov V, Raines AL, O'Connell J. Cryopreserved amniotic membrane improves clinical outcomes following microdiscectomy. Clin Spine Surg. 2017;30(9):413–418.
  3. Chen R, Huang G, Liu S, Ma W, Yin X, Zhou S. Limbal conjunctival versus amniotic membrane in the intraoperative application of mitomycin C for recurrent pterygium: a randomized controlled trial. Graefes Arch Clin Exp Ophthalmol. 2017;255(2):375-385.
  4. Clinicaltrials.gov. NCT04130061. Available at: https://clinicaltrials.gov/ct2/show/NCT04130061. Accessed September 25, 2020.
  5. Clinicaltrials.gov. NCT04417140. Available at: https://clinicaltrials.gov/ct2/show/NCT04417140. Accessed September 25, 2020.
  6. Clinicaltrials.gov. NCT03323021. Available at: https://clinicaltrials.gov/ct2/show/NCT03323021. Accessed September 25, 2020.
  7. Clinicaltrials.gov. NCT02526173. Available at: https://clinicaltrials.gov/ct2/show/NCT02526173. Accessed September 25, 2020.
  8. Clinicaltrials.gov. NCT04075357. Available at: https://clinicaltrials.gov/ct2/show/NCT04075357. Accessed September 25, 2020.
  9. Clinicaltrials.gov. NCT02719288. Available at: https://clinicaltrials.gov/ct2/show/NCT02719288. Accessed September 25, 2020.
  10. de Farias CC, Allemann N, Gomes JAP. Randomized trial comparing amniotic membrane transplantation with lamellar corneal graft for the treatment of corneal thinning. Cornea. 2016;35(4):438–444.
  11. Eslani M, Baradaran-Rafii A, Cheung AY, et al. Amniotic membrane transplantation in acute severe ocular chemical injury: A randomized clinical trial. Am J Ophthalmol. 2019;199:209–215.
  12. Faramarzi M, Kaboodkhani R, Sareh Roosta 1, Azarpira N, Shishegar M, Bahranifard H. Application of amniotic membrane for covering mastoid cavity in canal wall down mastoidectomy. Laryngoscope. 2019;129(6):1453–1457.
  13. Gan L, Duan H, Sun FQ, Xu Q, Tang YQ, Wang S. Efficacy of freeze-dried amnion graft following hysteroscopic adhesiolysis of severe intrauterine adhesions. Int J Gynaecol Obstet. 2017;137(2):116–122.
  14. Hassan M, Prakasam S, Bain C, Ghoneima A, Liu SSY. A randomized split-mouth clinical trial on effectiveness of amnion-chorion membranes inalveolar ridge preservation: A clinical, radiologic, and morphometric study. Int J Oral Maxillofac Implants. 2017;32(6):1389–1398.
  15. Kassem RR, Kamal AM, El-Mofty RMA, Elhilali HM. A controlled study of the role of cryopreserved amniotic membrane transplant during strabismus reoperations. J AAPOS. 2017;21(2):97–102.e1.
  16. Liu C, Bai J, Yu K, Liu G, Tian S, Tian D. Biological amnion prevents flexor tendon adhesion in zone II: A controlled, multicentre clinical trial. Biomed Res Int. 2019;2019:2354325.
  17. Scholz SL, Thomasen H, Hestermann K, Dekowski D, Steuhl KP, Meller D. Long-term results of autologous transplantation of limbal epithelium cultivated ex vivo for limbal stem cell deficiency. Ophthalmologe. 2016;113(4):321–329.
  18. Temraz A, Ghallab NA, Hamdy R, El-Dahab OA. Clinical and radiographic evaluation of amnion chorion membrane and demineralized bone matrix putty allograft for management of periodontal intrabony defects: a randomized clinical trial. Cell Tissue Bank. 2019;20(1):117–128.
  19. Turchan A, Rochman TF, Ibrahim A, et al. Duraplasty using amniotic membrane versus temporal muscle fascia: A clinical comparative study. J Clin Neurosci. 2018;50:272–276.
  20. Vlasov A, Sia RK, Ryan DS, et al. Sutureless cryopreserved amniotic membrane graft and wound healing after photorefractive keratectomy. J Cataract Refract Surg. 2016;42(3):435-43.
  21. Xue SL, Chen GG, Lü X, Mei R. Effects of human acellular amniotic membrane on postsurgical recovery of nail beds. Sichuan Da Xue Xue Bao Yi Xue Ban. 2016;47(4):533–536.
  22. Yadava U, Jaisingh K, Dangda S, Thacker P, Singh K, Goel Y. Simultaneous use of amniotic membrane and Mitomycin C in trabeculectomy for primary glaucoma. Indian J Ophthalmol. 2017;65(11):1151–1155.