Therapeutic Potential of Stem Cell Conditioned Medium on Chronic Ulcer Wounds

NCT04134676 | Completed Phase 1 DMC

• 1 other identifier: PML-KLB-02-2019
• Study Type: interventional
• Target: 38
• Locations: 1 country
• Sites: 3

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.

Conditions

Chronic Ulcer

Keywords

Stem Cell; Conditioned Medium

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

Conditioned Medium Group

EXPERIMENTAL

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

Interventions

Conditioned Media DRUG

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.

Conditioned Medium Group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subjects with chronic skin ulcer that had received therapy for more than 1 month but there were no improvements

You may not qualify if:

• Respondent who refused to be the subject of this research
• ulcer size \>10 x 15 cm

Sponsors & Collaborators

• Sukma Skin Treatment: lead
• Stem Cell and Cancer Institute, Kalbe Farma Tbk: collaborator
• PT Pharma Metric Labs: collaborator

Study Sites (3)

Mayapada Hospital

Tangerang, Banten, 15117, Indonesia

Location

Indra Clinic

Tangerang, Banten, 15710, Indonesia

Location

Sukma Cliniq

Tangerang, Banten, 15810, Indonesia

Location

Related Publications (23)

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Related Links

• 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

MeSH Terms

Interventions

Culture Media, Conditioned

Intervention Hierarchy (Ancestors)

Culture Media; Laboratory Chemicals; Specialty Uses of Chemicals; Chemical Actions and Uses; Equipment and Supplies

Study Officials

• Sukmawati T Tan, Dr. dr.

  Tarumanagara University

  PRINCIPAL INVESTIGATOR

• Siufui Hendrawan, Dr. dr

  Tarumanagara University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Experimental clinical trial with open label

Study Record Dates

• First Submitted: October 18, 2019
• First Posted: October 22, 2019
• Study Start: June 1, 2019
• Primary Completion: May 10, 2020
• Study Completion: June 10, 2020
• Last Updated: June 22, 2020

Record last verified: 2020-06

Data Sharing

• IPD Sharing: Will not share

Locations

ID (3)