Original Article

Clinical Grade Human Adipose Tissue-Derived Mesenchymal Stem Cell Banking


In this study, our aim was to produce a generation of GMP-grade adipose tissue-derived mesenchymal stem cells for clinical applications. According to our results, we fulfill to establish consistent and also reproducible current good manufacturing practice (cGMP) compliant adipose tissue-derived mesenchymal stem cells from five female donors. The isolated cells were cultured in DMEM supplemented with 10% fetal bovine serum and characterized by standard methods. Moreover, karyotyping was performed to evaluate chromosomal stability. Mean of donors’ age was 47.6 ± 8.29 year, mean of cell viability was 95.6 ± 1.51%, and cell count was between 9×106 and 14×106 per microliter with the mean of 12.2×106 ± 2863564.21 per microliter. The main aim of this project was demonstrating the feasibility of cGMP-compliant and clinical grade adipose tissue-derived mesenchymal stem cells preparation and banking for clinical cell transplantation trials.

Thirumala S, Goebel WS, Woods EJ. Clinical grade adult stem cell banking. Organogenesis 2009;5(3):143-54.

Burger S. Current regulatory issues in cell and tissue therapy. Cytotherapy 2003;5(4):289-98.

Prince HM, Wall DP, Stokes KH, et al. Cell Processing for Clinical Trials and Commercial Manufacture. Cell Gene Ther 2004;1(1):15-21.

Tarte K, Gaillard J, Lataillade JJ, et al. Clinical-grade production of human mesenchymal stromal cells: occurrence of aneuploidy without transformation. Blood 2010;115(8):1549-53.

Vishnubalaji R, Al-Nbaheen M, Kadalmani B, et al. Comparative investigation of the differentiation capability of bone-marrow-and adipose-derived mesenchymal stem cells by qualitative and quantitative analysis. Cell Tissue Res 2012;347(2):419-27.

Bieback K, Schallmoser K, Klüter H, et al. Clinical protocols for the isolation and expansion of mesenchymal stromal cells. Transfus Med Hemother 2008;35(4):286-94.

Schäffler A, Büchler C. Concise Review: Adipose Tissue- Derived Stromal Cells--Basic and Clinical Implications for Novel Cell-Based Therapies. Stem Cells 2007;25(4):818-27.

Lin G, Banie L, Ning H, et al. Potential of Adipose Derived Stem Cells for Treatment of Erectile Dysfunction. J Sex Med 2009;6(Suppl 3):320-7.

Reichenberger MA, Heimer S, Schaefer A, et al. Adipose Derived Stem Cells Protect Skin Flaps Against Ischemia- Reperfusion Injury. Stem Cell Rev 2012;8(3):854-62.

MacIsaac ZM, Shang H, Agrawal H, et al. Long-term invivo tumorigenic assessment of human culture-expanded adipose stromal/stem cells. Exp Cell Res 2012;318(4):416-23.

Mizuno H, Tobita M, Uysal AC. Concise Review: Adipose Derived Stem Cells as a Novel Tool for Future Regenerative Medicine. Stem Cells 2012;30(5):804-10.

Yarak S, Okamoto OK. Human adipose-derived stem cells: current challenges and clinical perspectives. An BrasDermatol 2010;85(5):647-56.

Harris LJ, Zhang P, Abdollahi H, et al. Availability of adipose-derived stem cells in patients undergoing vascular surgical procedures. J Surg Res 2010;163(2):e105-12.

Yamamoto T, Gotoh M, Hattori R, et al. Periurethral injection of autologous adipose-derived stem cells for the treatment of stress urinary incontinence in patients undergoing radical prostatectomy: report of two initial cases. Int J Urol 2010;17(1):75-82.

Brown SG, Harman RJ, Black LL. Adipose-derived stem cell therapy for severe muscle tears in working German shepherds: Two case reports. Stem Cell Discovery 2012;2(2):41-4.

Wang Y, Lian F, Li J, et al. Adipose derived mesenchymal stem cells transplantation via portal vein improves microcirculation and ameliorates liver fibrosis induced by CCl4 in rats. J Transl Med 2012;10(1):133.

Herberts CA, Kwa M, Hermsen HP. Risk factors in the development of stem cell therapy. J Transl Med 2011;9(1):29.

Gir P, Oni G, Brown SA, et al. Human adipose stem cells: current clinical applications. Plast Reconstr Surg 2012;129(6):1277-90.

Gimble JM, Guilak F, Bunnell BA. Clinical and preclinical translation of cell-based therapies using adipose tissuederived cells. Stem Cell Res Ther 2010;1(2):19.

Fekete N, Rojewski MT, Fürst D, et al. GMP-Compliant Isolation and Large-Scale Expansion of Bone Marrow- Derived MSC. PloS One 2012;7(8):e43255.

Maekawa T, Kimura S, Kasai Y. Development of Novel Advanced Cell and Gene Therapy and GMP-Controlled Cell Processing. JMAJ 2005;48(2):81-4.

Arjmand B, Aghayan HR. Cell manufacturing for clinical applications. Stem Cells 2014;32(9):2557-8.

Cuende N, Izeta A. Clinical translation of stem cell therapies: a bridgeable gap. Cell Stem Cell 2010;6(6):508-12.

Larijani B, Arjmand B, Amoli MM, et al. Establishing a cGMP pancreatic islet processing facility: the first experience in Iran. Cell Tissue Bank 2012;13(4):569-75.

Burger SR. Design and operation of a current good= manufacturing practices cell-engineering laboratory. Cytotherapy 2000;2(2):111-22.

Arjmand B, Emami-Razavi SH, Larijani B, et al. The implementation of tissue banking experiences for setting up a cGMP cell manufacturing facility. Cell Tissue Bank 2012;13(4):587-96.

Warnke PH, Humpe A, Strunk D, et al. A clinicallyfeasible protocol for using human platelet lysate and mesenchymal stem cells in regenerative therapies. J Craniomaxillofac Surg 2012;41(2):153-61.

Dominici M, Le Blanc K, Mueller I, et al. Minimal criteria for defining multipotent mesenchymal stromal cells. The International Society for Cellular Therapy position statement. Cytotherapy 2006;8(4):315-7.

Romagnoli L, Giuntini I, Galgano M, et al. Cell-based medicinal products and the development of GMPcompliant processes and manufacturing. BMC Proc 2011:5(Suppl 8):O3.

Hartmann I, Hollweck T, Haffner S, et al. Umbilical cord tissue-derived mesenchymal stem cells grow best under GMP-compliant culture conditions and maintain their phenotypic and functional properties. J Immunol Methods 2010;363(1):80-9.

Brooke G, Rossetti T, Pelekanos R, et al. Manufacturing of human placenta derived mesenchymal stem cells for clinical trials. Br J Hematol 2009;144(4):571-9.

Ilic N, Brooke G, Murray P, et al. Manufacture of clinical grade human placenta-derived multipotent mesenchymal stromal cells. Methods Mol Biol 2011;698:89-106.

IssueVol 53, No 9 (2015) QRcode
SectionOriginal Article(s)
Adipose-derived stem cell Cell therapy Good manufacturing practice Mesenchymal stem cells

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How to Cite
Larijani B, Aghayan H, Goodarzi P, Mohamadi-Jahani F, Norouzi-Javidan A, Dehpour AR, Fallahzadeh K, Azam Sayahpour F, Bidaki K, Arjmand B. Clinical Grade Human Adipose Tissue-Derived Mesenchymal Stem Cell Banking. Acta Med Iran. 53(9):540-546.