Therapeutic Potential of Stem Cell Conditioned Medium on Chronic Ulcer Wounds
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|ClinicalTrials.gov Identifier: NCT04134676|
Recruitment Status : Completed
First Posted : October 22, 2019
Last Update Posted : June 22, 2020
|Condition or disease||Intervention/treatment||Phase|
|Chronic Ulcer||Drug: Conditioned Media||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||38 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||Experimental clinical trial with open label|
|Masking:||None (Open Label)|
|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|
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.
- 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.
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
|Tangerang, Banten, Indonesia, 15117|
|Tangerang, Banten, Indonesia, 15710|
|Tangerang, Banten, Indonesia, 15810|
|Principal Investigator:||Sukmawati T Tan, Dr. dr.||Faculty of Medicine, Tarumanagara University|
|Study Director:||Siufui Hendrawan, Dr. dr||Faculty of Medicine, Tarumanagara University|