Chronic UlcerPhase 1NCT04134676
Therapeutic Potential of Stem Cell Conditioned Medium on Chronic Ulcer Wounds
A Phase 1 study testing Conditioned Media in people with Chronic Ulcer, run by Sukma Skin Treatment at 3 sites in Indonesia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Chronic Ulcer
- What is being tested?
- Conditioned Media
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 38 participants
- Where
- 3 sitesIndonesia
- Study dates
- 1 Jun 2019to 10 Jun 2020
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Subjects with chronic skin ulcer that had received therapy for more than 1 month but there were no improvements
Who cannot join
- Respondent who refused to be the subject of this research
- ulcer size >10 x 15 cm
Trial locations and contacts
3 sites in 1 country.
Indonesia3 sites
Mayapada Hospital
Tangerang, Banten, 15117
Indra Clinic
Tangerang, Banten, 15710
Sukma Cliniq
Tangerang, Banten, 15810
About this study
Official title: Therapeutic Potential of Stem Cell Conditioned Medium on Chronic Ulcer Wounds : Pilot Study in Human
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.
Read the detailed description
Treatment for chronic wound healing has become a great challenge in medical world. The incidence of chronic non healing wounds continues to increase and the classical method for wound healing therapy no longer reliable for chronic wounds healing. Therefore a new alternative strategy to control chronic wound healing is needed. Stem cell therapy has become a leading alternative strategy for wound healing therapy in this new modern world. The development of using conditioned medium such as Wharton's Jelly Mesenchymal Stem Cells have arising because of its paracrine factors that can provide a better healing process. During daily practice at the clinic, the authors sometimes find patients with chronic skin ulcers that cannot be treated using standard therapy. This encourages the authors to innovate new therapy to help the wound healing process by using human WJ-MSC conditioned medium.
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
- Chronic Ulcer
- Being tested
- Conditioned Media
- Keywords
- Stem Cell, Conditioned Medium
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Conditioned MediaDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Conditioned Media |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: The ulcer is measured after 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Oct 2019
- Study start1 Jun 2019
- Primary completion10 May 2020
- Study completion10 Jun 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (23)Papers the sponsor has linked to this study.
- Other trials for Chronic UlcerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Experimental clinical trial with open label
- Masking
- None (open label)
- Enrolment
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sukma Skin Treatment
- Sponsor type
- University, hospital or other
- Collaborators
- Stem Cell and Cancer Institute, Kalbe Farma Tbk, PT Pharma Metric Labs
- Responsible party
- Sponsor
- Investigators
- Sukmawati T Tan, Dr. dr., Principal investigator, Tarumanagara UniversitySiufui Hendrawan, Dr. dr, Study director, Tarumanagara University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04134676
- Sponsor's protocol ID
- PML-KLB-02-2019
- Status last verified
- Jun 2020
- First submitted
- 18 Oct 2019
- Last updated
- 22 Jun 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Li J, Chen J, Kirsner R. Pathophysiology of acute wound healing. Clin Dermatol. 2007 Jan-Feb;25(1):9-18. doi: 10.1016/j.clindermatol.2006.09.007.
PubMed 17276196de la Garza-Rodea AS, Knaan-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.
PubMed 22116308Posnett J, Franks PJ. The burden of chronic wounds in the UK. Nurs Times. 2008 Jan 22-28;104(3):44-5.
PubMed 18293879Turner 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. doi: 10.1089/wound.2014.0604.
PubMed 26244105Bluestein D, Javaheri A. Pressure ulcers: prevention, evaluation, and management. Am Fam Physician. 2008 Nov 15;78(10):1186-94.
PubMed 19035067Xu 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.
PubMed 27057176Arno 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.
PubMed 24564987Khosrotehrani K. Mesenchymal stem cell therapy in skin: why and what for? Exp Dermatol. 2013 May;22(5):307-10. doi: 10.1111/exd.12141.
PubMed 23614735Klopp 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.
PubMed 21280155Kim 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.
PubMed 19047138Beckermann 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, Buchler MW, Friess H, Buchler 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.
PubMed 18665180Ho 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.
PubMed 28616360Sinno 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.
PubMed 23984063McDaniel 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.
PubMed 25188797Coleman 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.
PubMed 23375662
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Therapeutic Potential of Stem Cell Conditioned Medium on Chronic Ulcer Wounds : Pilot Study in Human
- ClinicalTrials.gov ID
- NCT04134676
- Acronym / sponsor ID
- PML-KLB-02-2019
- Conditions
- Chronic Ulcer
- Keywords
- Stem Cell, Conditioned Medium
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 38 participants (actual)
- Lead sponsor
- Sukma Skin TreatmentUniversity, hospital or other
- Collaborators
- Stem Cell and Cancer Institute, Kalbe Farma Tbk, PT Pharma Metric Labs
- Study start
- 1 Jun 2019 (actual)
- Primary completion
- 10 May 2020 (actual)
- Study completion
- 10 Jun 2020 (actual)
- First posted
- 22 Oct 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Treatment for chronic wound healing has become a great challenge in medical world. The incidence of chronic non healing wounds continues to increase and the classical method for wound healing therapy no longer reliable for chronic wounds healing. Therefore a new alternative strategy to control chronic wound healing is needed. Stem cell therapy has become a leading alternative strategy for wound healing therapy in this new modern world. The development of using conditioned medium such as Wharton's Jelly Mesenchymal Stem Cells have arising because of its paracrine factors that can provide a better healing process. During daily practice at the clinic, the authors sometimes find patients with chronic skin ulcers that cannot be treated using standard therapy. This encourages the authors to innovate new therapy to help the wound healing process by using human WJ-MSC conditioned medium.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Experimental clinical trial with open label
| Arm | Type | Receives |
|---|---|---|
| Conditioned Medium Group | Experimental | Drug: Conditioned MediaIn 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. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Subjects with chronic skin ulcer that had received therapy for more than 1 month but there were no improvements
Key exclusion criteria (2 listed)
- Respondent who refused to be the subject of this research
- ulcer size >10 x 15 cm
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Conditioned MediaConditioned 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. | Drug | Conditioned Medium Group |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jun 2020.
- Background: PubMed 17276196Li J, Chen J, Kirsner R. Pathophysiology of acute wound healing. Clin Dermatol. 2007 Jan-Feb;25(1):9-18. doi: 10.1016/j.clindermatol.2006.09.007.
- Background: PubMed 22116308de la Garza-Rodea AS, Knaan-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.
- Background: PubMed 18293879Posnett J, Franks PJ. The burden of chronic wounds in the UK. Nurs Times. 2008 Jan 22-28;104(3):44-5.
- Background: PubMed 26244105Turner 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. doi: 10.1089/wound.2014.0604.
- Background: PubMed 19035067Bluestein D, Javaheri A. Pressure ulcers: prevention, evaluation, and management. Am Fam Physician. 2008 Nov 15;78(10):1186-94.
- Background: PubMed 27057176Xu 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.
- Background: PubMed 24564987Arno 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.
- Background: PubMed 23614735Khosrotehrani K. Mesenchymal stem cell therapy in skin: why and what for? Exp Dermatol. 2013 May;22(5):307-10. doi: 10.1111/exd.12141.
- Background: PubMed 21280155Klopp 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.
- Background: PubMed 19047138Kim 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.
- Background: PubMed 18665180Beckermann 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, Buchler MW, Friess H, Buchler 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.
- Background: PubMed 28616360Ho 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.
- Immune characterization of mesenchymal stem cells in human umbilical cord Wharton's jelly and derived cartilage cellsLink provided by the sponsor.
- Individual participant dataSharing planned: No
Related trials for Chronic Ulcer
Recruiting
PAW-Hydrogel for Chronic Wound Healing
Diabetic Foot Ulcer (DFU), Pressure Ulcer (PU)
Recruiting
Efficacy and Safety of ZKARE® Gel and Its Accessory ZKAPI® in the Treatment of Chronic Ulcers.
Chronic Ulcers
Active, not recruiting
To Develop Methods for the Rehabilitation of Chronic Gastroduodenal Pathology in Children.
Gastritis Chronic, Gastroduodenitis
RecruitingPhase 1/2
An Open-Label, Proof of Consent Study of Vorinostat for the Treatment of Mdoerate-to-Severe Crohn s Disease and Maintenance Therapy With Ustekinumab
Crohn's Disease
Recruiting
Vacuum Compression Therapy and Tissue Oxygenation in Chronic Leg Ulcers
Leg Ulcers, Leg Ulcers Venous
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sukmawati T Tan, Dr. dr. principal investigator
Tarumanagara University
Siufui Hendrawan, Dr. dr study director
Tarumanagara University
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Conditioned Media in people with Chronic Ulcer, run by Sukma Skin Treatment at 3 sites in Indonesia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Indonesia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04134676, which also lists 23 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jun 2020.