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Therapeutic Potential of Stem Cell Conditioned Medium on Chronic Ulcer Wounds

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04134676
Recruitment Status : Completed
First Posted : October 22, 2019
Last Update Posted : June 22, 2020
Sponsor:
Collaborators:
Stem Cell and Cancer Institute, Kalbe Farma Tbk
PT. Pharma Metric Labs
Information provided by (Responsible Party):
Sukma Skin Treatment

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Chronic Ulcer Drug: Conditioned Media Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 38 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: Experimental clinical trial with open label
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Therapeutic Potential of Stem Cell Conditioned Medium on Chronic Ulcer Wounds : Pilot Study in Human
Actual Study Start Date : June 1, 2019
Actual Primary Completion Date : May 10, 2020
Actual Study Completion Date : June 10, 2020

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Arm Intervention/treatment
Experimental: 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.

Drug: 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.




Primary Outcome Measures :
  1. Knowing the the success rate of chronic ulcer healing in patients undergoing wound care with conditioned medium [ Time Frame: The ulcer is measured after 2 weeks ]

    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.




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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04134676


Locations
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Indonesia
Mayapada Hospital
Tangerang, Banten, Indonesia, 15117
Indra Clinic
Tangerang, Banten, Indonesia, 15710
Sukma Cliniq
Tangerang, Banten, Indonesia, 15810
Sponsors and Collaborators
Sukma Skin Treatment
Stem Cell and Cancer Institute, Kalbe Farma Tbk
PT. Pharma Metric Labs
Investigators
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Principal Investigator: Sukmawati T Tan, Dr. dr. Faculty of Medicine, Tarumanagara University
Study Director: Siufui Hendrawan, Dr. dr Faculty of Medicine, Tarumanagara University
Additional Information:
Publications:

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Responsible Party: Sukma Skin Treatment
ClinicalTrials.gov Identifier: NCT04134676    
Other Study ID Numbers: PML-KLB-02-2019
First Posted: October 22, 2019    Key Record Dates
Last Update Posted: June 22, 2020
Last Verified: June 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Sukma Skin Treatment:
Stem Cell
Conditioned Medium
Additional relevant MeSH terms:
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Ulcer
Pathologic Processes