Chronic Ulcer Clinical Trial
Official title:
Therapeutic Potential of Stem Cell Conditioned Medium on Chronic Ulcer Wounds : Pilot Study in Human
Verified date | June 2020 |
Source | Sukma Skin Treatment |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Chronic wounds (CW) still represents a heavy burden to many patients and health care institution. Despite the most recent advances in wound management, up to 50% of chronic wounds still fail to heal. Conventional treatment of chronic wounds does not seem to work in several cases, consumes enormous amount of money and time, so it is necessary to develop different strategies. Previous studies have reported stem cells ability in tissue regenerations due mainly to its secreted paracrine factors, rather than its differentiation ability to become new cells. The factors is called secretomes, microvesicles, or exosomes, that can be found in the medium where the cells are growing, therefore it called conditioned medium (CM). Mesenchymal stem cells (MSCs) such as Wharton's Jelly Mesenchymal Stem Cells (WJ-MSC) appear to emerge as a promising wound healing therapy. To the best of investigator's knowledge, after conducted a pilot study using animal model to gain the preliminary data for the ulcer healing potential, this is the investigator's first clinical study to see the therapeutic potentials of Conditioned Medium Stem Cell as an additional growth factors in chronic skin ulcer healing and to compare the success of chronic ulcer healing in patients undergoing CM treatment and standard approach. The investigators will examine the therapeutic effect of human WJ-MSC-CM in wound healing on patients with chronic skin ulcer.
Status | Completed |
Enrollment | 38 |
Est. completion date | June 10, 2020 |
Est. primary completion date | May 10, 2020 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 80 Years |
Eligibility |
Inclusion Criteria: - Subjects with chronic skin ulcer that had received therapy for more than 1 month but there were no improvements Exclusion Criteria: - Respondent who refused to be the subject of this research - ulcer size >10 x 15 cm |
Country | Name | City | State |
---|---|---|---|
Indonesia | Indra Clinic | Tangerang | Banten |
Indonesia | Mayapada Hospital | Tangerang | Banten |
Indonesia | Sukma Cliniq | Tangerang | Banten |
Lead Sponsor | Collaborator |
---|---|
Sukma Skin Treatment | PT. Pharma Metric Labs, Stem Cell and Cancer Institute, Kalbe Farma Tbk |
Indonesia,
Arno AI, Amini-Nik S, Blit PH, Al-Shehab M, Belo C, Herer E, Tien CH, Jeschke MG. Human Wharton's jelly mesenchymal stem cells promote skin wound healing through paracrine signaling. Stem Cell Res Ther. 2014 Feb 24;5(1):28. doi: 10.1186/scrt417. — View Citation
Beckermann BM, Kallifatidis G, Groth A, Frommhold D, Apel A, Mattern J, Salnikov AV, Moldenhauer G, Wagner W, Diehlmann A, Saffrich R, Schubert M, Ho AD, Giese N, Büchler MW, Friess H, Büchler P, Herr I. VEGF expression by mesenchymal stem cells contributes to angiogenesis in pancreatic carcinoma. Br J Cancer. 2008 Aug 19;99(4):622-31. doi: 10.1038/sj.bjc.6604508. Epub 2008 Jul 29. — View Citation
Bluestein D, Javaheri A. Pressure ulcers: prevention, evaluation, and management. Am Fam Physician. 2008 Nov 15;78(10):1186-94. — View Citation
Cerqueira MT, Pirraco RP, Marques AP. Stem Cells in Skin Wound Healing: Are We There Yet? Adv Wound Care (New Rochelle). 2016 Apr 1;5(4):164-175. Review. — View Citation
Choi M, Lee HS, Naidansaren P, Kim HK, O E, Cha JH, Ahn HY, Yang PI, Shin JC, Joe YA. Proangiogenic features of Wharton's jelly-derived mesenchymal stromal/stem cells and their ability to form functional vessels. Int J Biochem Cell Biol. 2013 Mar;45(3):560-70. doi: 10.1016/j.biocel.2012.12.001. Epub 2012 Dec 12. — View Citation
Coleman S, Gorecki C, Nelson EA, Closs SJ, Defloor T, Halfens R, Farrin A, Brown J, Schoonhoven L, Nixon J. Patient risk factors for pressure ulcer development: systematic review. Int J Nurs Stud. 2013 Jul;50(7):974-1003. doi: 10.1016/j.ijnurstu.2012.11.019. Epub 2013 Feb 1. Review. — View Citation
de la Garza-Rodea AS, Knaän-Shanzer S, van Bekkum DW. Pressure ulcers: description of a new model and use of mesenchymal stem cells for repair. Dermatology. 2011;223(3):266-84. doi: 10.1159/000334628. Epub 2011 Nov 23. — View Citation
Ho J, Walsh C, Yue D, Dardik A, Cheema U. Current Advancements and Strategies in Tissue Engineering for Wound Healing: A Comprehensive Review. Adv Wound Care (New Rochelle). 2017 Jun 1;6(6):191-209. doi: 10.1089/wound.2016.0723. Review. — View Citation
Khosrotehrani K. Mesenchymal stem cell therapy in skin: why and what for? Exp Dermatol. 2013 May;22(5):307-10. doi: 10.1111/exd.12141. — View Citation
Kim SM, Lim JY, Park SI, Jeong CH, Oh JH, Jeong M, Oh W, Park SH, Sung YC, Jeun SS. Gene therapy using TRAIL-secreting human umbilical cord blood-derived mesenchymal stem cells against intracranial glioma. Cancer Res. 2008 Dec 1;68(23):9614-23. doi: 10.1158/0008-5472.CAN-08-0451. — View Citation
Klopp AH, Gupta A, Spaeth E, Andreeff M, Marini F 3rd. Concise review: Dissecting a discrepancy in the literature: do mesenchymal stem cells support or suppress tumor growth? Stem Cells. 2011 Jan;29(1):11-9. doi: 10.1002/stem.559. Review. — View Citation
Li J, Chen J, Kirsner R. Pathophysiology of acute wound healing. Clin Dermatol. 2007 Jan-Feb;25(1):9-18. Review. — View Citation
McDaniel JC, Browning KK. Smoking, chronic wound healing, and implications for evidence-based practice. J Wound Ostomy Continence Nurs. 2014 Sep-Oct;41(5):415-23; quiz E1-2. doi: 10.1097/WON.0000000000000057. — View Citation
Pittenger MF, Mackay AM, Beck SC, Jaiswal RK, Douglas R, Mosca JD, Moorman MA, Simonetti DW, Craig S, Marshak DR. Multilineage potential of adult human mesenchymal stem cells. Science. 1999 Apr 2;284(5411):143-7. — View Citation
Posnett J, Franks PJ. The burden of chronic wounds in the UK. Nurs Times. 2008 Jan 22-28;104(3):44-5. Review. — View Citation
Sarasúa JG, López SP, Viejo MA, Basterrechea MP, Rodríguez AF, Gutiérrez AF, Gala JG, Menéndez YM, Augusto DE, Arias AP, Hernández JO. Treatment of pressure ulcers with autologous bone marrow nuclear cells in patients with spinal cord injury. J Spinal Cord Med. 2011;34(3):301-7. doi: 10.1179/2045772311Y.0000000010. — View Citation
Short B, Brouard N, Occhiodoro-Scott T, Ramakrishnan A, Simmons PJ. Mesenchymal stem cells. Arch Med Res. 2003 Nov-Dec;34(6):565-71. Review. — View Citation
Singh R, Singh R, Rohilla RK, Siwach R, Verma V, Kaur K. Surgery for pressure ulcers improves general health and quality of life in patients with spinal cord injury. J Spinal Cord Med. 2010;33(4):396-400. — View Citation
Sinno H, Prakash S. Complements and the wound healing cascade: an updated review. Plast Surg Int. 2013;2013:146764. doi: 10.1155/2013/146764. Epub 2013 Jul 24. — View Citation
Spaeth EL, Dembinski JL, Sasser AK, Watson K, Klopp A, Hall B, Andreeff M, Marini F. Mesenchymal stem cell transition to tumor-associated fibroblasts contributes to fibrovascular network expansion and tumor progression. PLoS One. 2009;4(4):e4992. doi: 10.1371/journal.pone.0004992. Epub 2009 Apr 7. Erratum in: PLoS One. 2013; 8(3). doi:10.1371/annotation/4ab4c130-16cb-41f0-9507-b00ce070fbc6. — View Citation
Turner NJ, Badylak SF. The Use of Biologic Scaffolds in the Treatment of Chronic Nonhealing Wounds. Adv Wound Care (New Rochelle). 2015 Aug 1;4(8):490-500. Review. — View Citation
Vizoso FJ, Eiro N, Cid S, Schneider J, Perez-Fernandez R. Mesenchymal Stem Cell Secretome: Toward Cell-Free Therapeutic Strategies in Regenerative Medicine. Int J Mol Sci. 2017 Aug 25;18(9). pii: E1852. doi: 10.3390/ijms18091852. Review. — View Citation
Xu Y, Guo S, Wei C, Li H, Chen L, Yin C, Zhang C. The Comparison of Adipose Stem Cell and Placental Stem Cell in Secretion Characteristics and in Facial Antiaging. Stem Cells Int. 2016;2016:7315830. doi: 10.1155/2016/7315830. Epub 2016 Feb 8. — View Citation
* Note: There are 23 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Knowing the the success rate of chronic ulcer healing in patients undergoing wound care with conditioned medium | Assessing ulcer progression macroscopic evaluation of: The presence of granulation tissue The size of the ulcer reduced Edema decreases Erythema decreases Results are expressed as means ± SD. The normal distribution of the data was assessed using the Shapiro-Wilk test. For multiple comparisons One-Way Analysis of Variance (ANOVA) was used. The significance between two independent groups was determined by independent Student's t-test and the Mann-Whitney test. An unpaired t-test was performed if the data were normally distributed. Otherwise, a Mann-Whitney test was used. Statistical analysis was 2-tailed and values were considered statistically significant at p < 0.05. |
The ulcer is measured after 2 weeks |
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