Therapeutic Potential of Stem Cell Conditioned Medium on Chronic Ulcer Wounds
NCT ID: NCT04134676
Last Updated: 2020-06-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
38 participants
INTERVENTIONAL
2019-06-01
2020-06-10
Brief Summary
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Detailed Description
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This study has several purposes, such as; to observe the success rate, the differences in the period of time needed, and the differences in wound closure of chronic ulcer healing in patients undergoing wound care with conditioned medium and standard therapy. As for the benefits of research, these are the benefits; reducing the cost spent on treatment in chronic skin ulcer, faster chronic wound healing while minimizing the complications, improving the quality of therapy for patients with chronic skin ulcers, reducing the treatment period for chronic skin ulcer and can be used as the basis for future researchers to conduct further research on Conditioned Medium Stem Cell and chronic wound management.
Stem cell therapy constitutes a new alternative methods of wound healing. Many researchers are relying on this alternative new therapy that holds great potentials for its growth factors. Mesenchymal stem cell (MSCs) have been isolated from many types of adult tissues and fetal tissues, such as umbilical cord, skin, and placenta. When engrafted at sites of tissue injury, MSCs differentiate into connective tissue elements, support vasculogenesis, and secretes cytokines and growth factors that facilitate healing. As in wounds, MSCs differentiate into fibroblasts and pericytes and, perhaps, endothelial-like or vessel attached cells. WJ-MSCs secrete proangiogenic and wound healing promoting factors, such as transforming growth factor beta (TGF-β), vascular endothelial growth factor (VEGF), platelet-derived growth factor, insulin-like growth factor-I, interleukin (IL)-6 and IL-8.
The use of MSC-sourced secretome in regenerative medicine provides key advantages over stem-cell based applications such as; (a) resolving several safety considerations potentially associated with the transplantation of living and proliferative cell populations, (b) can be evaluated for safety, dosage and potency, (c) storage can be done without application of potentially toxic cryopreservative agents for a long period without loss of product potency, (d) using MSC-sourced secretome, such as conditioned medium (CM), is more economical and more practical for clinical application since it avoids invasive cell collection procedures, (e) the time and cost of expansion and maintenance of cultured stem cells could be greatly reduced, (f) finally, the biological product obtained for therapeutic applications could be modified to desired cell-specific effects.
This research is an experimental clinical trial with open label. This research will be conducted in Sitanala Village (RW 001), Mayapada Hospital, Indra Clinic and Sukma Clinic, Banten. Conditioned Medium Stem Cell obtained from SCI (PT. Kalbe Farma, Tbk.). The study started from June 2019 to June 2020. The sample used from this study are all outpatient and hospitalized patients with chronic skin ulcers at Mayapada Hospital, Indra Clinic, Sukma Clinic and Sitanala Village (RW 001) from June 2019 until May 2020. In this pilot study, 38 subjects will be included based on estimated sample size. The method of selecting samples is by using consecutive sampling. Data was collected by measuring the first ulcer and taking photos of each subject. The patient then use CM topical therapy and the evaluation is carried out after 2 weeks. 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.
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Conditioned Medium Group
In this group, the subjects will use Conditioned Medium topical therapy for 2 weeks The Conditioned Medium gel will be applied to the wound and closed by transparent dressing.
The evaluation and dressing replacement will be done every week for 2 weeks.
Conditioned Media
Conditioned Media represents the complete regenerative milieu of cell-sourced secretome and vesicular elements. The soluble components of the secretome may be separated from the microvesicle fraction by centrifugation, filtration, polymer precipitation-based methodologies, ion exchange chromatography and size-exclusion chromatography. Both of these components may be capable of independently triggering regeneration and repair as well as of mediating the de novo organogenesis of tissue-engineered organs ex vivo.
Interventions
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Conditioned Media
Conditioned Media represents the complete regenerative milieu of cell-sourced secretome and vesicular elements. The soluble components of the secretome may be separated from the microvesicle fraction by centrifugation, filtration, polymer precipitation-based methodologies, ion exchange chromatography and size-exclusion chromatography. Both of these components may be capable of independently triggering regeneration and repair as well as of mediating the de novo organogenesis of tissue-engineered organs ex vivo.
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* ulcer size \>10 x 15 cm
18 Years
80 Years
ALL
Yes
Sponsors
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Stem Cell and Cancer Institute, Kalbe Farma Tbk
UNKNOWN
PT Pharma Metric Labs
INDUSTRY
Sukma Skin Treatment
OTHER
Responsible Party
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Principal Investigators
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Sukmawati T Tan, Dr. dr.
Role: PRINCIPAL_INVESTIGATOR
Tarumanagara University
Siufui Hendrawan, Dr. dr
Role: STUDY_DIRECTOR
Tarumanagara University
Locations
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Mayapada Hospital
Tangerang, Banten, Indonesia
Indra Clinic
Tangerang, Banten, Indonesia
Sukma Cliniq
Tangerang, Banten, Indonesia
Countries
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References
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Related Links
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Immune characterization of mesenchymal stem cells in human umbilical cord Wharton's jelly and derived cartilage cells
Evidence-based management strategies for treatment of chronic wounds
Other Identifiers
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PML-KLB-02-2019
Identifier Type: -
Identifier Source: org_study_id
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