Diabetic Foot UlcerPhase 1/2NCT06231771
Safety and Efficacy of Stem Cells for Diabetic Foot Ulcer
A Phase 1/2 study testing Allogeneic mesenchymal stem cells (MSCs) and Normal Saline in people with Diabetic Foot Ulcer, run by Supergenics Life Science Sdn. Bhd..
Trial summary
The objective of this clinical trial is to evaluate the effectiveness and safety of Wharton-Jelly mesenchymal stem cells administered around the ulcer site in patients with nonhealing diabetic foot ulcers. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Diabetic Foot Ulcer
- What is being tested?
- Allogeneic mesenchymal stem cells (MSCs) and Normal Saline
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 22 participants
- Where
- No sites listed yet
- Study dates
- May 2024to 30 Dec 2024
- Phase
- Phase 1/2
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients between 18-70 years old.
- Patients have type 2 diabetes mellitus
- Patients with HbA1c, less than or equal to 10%.
- Patients who were presented with an ulcer size between 8 to 12 cm2, have been diagnosed as full-thickness DFU.
- Adequate vascular perfusion (ABI ≥ 0.7 and < 1.3)
- Patients who are able and willing to provide consent and agree to comply with study procedures and follow-up evaluations.
Who cannot join
- Patients who are not diabetic.
- Patients with 2 or more ulcers.
- Patients with a history of participating in another stem cells trial or therapy within 3 months.
- Patients who are unsuitable to participate the clinical trial as determined by Investigators.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: A Randomized, Double Blind, Placebo Controlled, Phase I/II Study Assessing the Efficacy and Safety of Peri-Ulcer Administration of Wharton-Jelly Mesenchymal Stem Cells in Patients With Non-Healing Diabetic Foot Ulcer
The objective of this clinical trial is to evaluate the effectiveness and safety of Wharton-Jelly mesenchymal stem cells administered around the ulcer site in patients with nonhealing diabetic foot ulcers. The key inquiries it seeks to address include the percentage of patients achieving complete healing/closure of the specified ulcer at any point during the 6-week period, the duration required for the complete closure of the target ulcer, and the nature and occurrence of adverse events (AEs), along with the total number of AEs and the proportion of patients experiencing AEs.
Patients meeting the eligibility criteria will receive either allogeneic mesenchymal stromal cells (MSC) or a placebo. The peri-ulcer injection of umbilical cord MSC or placebo will be administered at multiple locations, around the ulcer. Subsequent follow-up after the administration of umbilical cord MSC or placebo will be conducted to monitor and observe the progress of ulcer healing.
Read the detailed description
Research involving MSCs promises new treatments and possible cures for many chronic and debilitating diseases. It has been shown that MSCs could be an effective therapy for many diseases, including CLI, AMI, OA of the knee, LC and DFU. No significant side effects have been reported with allogeneic MSC therapy in preclinical and clinical studies. Also, the potential benefits of MSC technology are compelling and worthy of pursuit in accordance with the appropriate ethical standards and regulatory guidelines. Both basic and clinical research suggest that allogeneic MSCs are likely to solve many unmet clinical needs, and this can be made available as an off-the-shelf product. the injective if this study was to evaluate the efficacy of peri-ulcer administration of Umbilical cord MSC in the healing of DFU and assess the safety of peri-ulcer administration of Umbilical cord MSC in DFU by assess the • Proportion of patients with complete healing/closure of the target ulcer at any time during the 6-weeks period and proportion of patients with sustained complete closure for additional 6-weeks of follow-up. besides that, this study also will assess the time to complete closure of target ulcer and rate of reduction in the size of the target ulcer during the 6 weeks of follow-up and proportion of patients with at least 50% closure of target ulcer during the 6-weeks period. this study is Double-blind, placebo-controlled, randomized trial. Estimated duration for the main protocol (e.g., from starts of screening to last subject processed and end of the study) is approximately 9 months at Hospital Canselor Tunku Muhriz (HCTM), Jalan Yaacob Latif, Bandar Tun Razak, 56000 Kuala Lumpur, Wilayah Persekutuan, Malaysia using Ex-vivo cultured allogeneic mesenchymal stem cells (MSCs) supplied in vials consisting of 3 million cells, suspended in 1.5 ml saline (3 million cells/1.5 mL) with dosage of 1 million cells/cm2 of ulcer. The administration of the product will be through the peri-ulcer route. The injection will be done using a 24G needle and 1 ml/3 ml syringe approximately within 0.75 cm from the edge of the ulcer. The needle should enter the base of the ulcer from the edge.
Injection of Umbilical cord MSC (1 million cells/cm2 of the ulcer) will be administered at multiple sites (maximum of 30 sites) with intervals of 3 cm x 3 cm around the ulcer in a total volume of 0.1 to 0.2 ml per injection.
- Conditions
- Diabetic Foot Ulcer
- Being tested
- Allogeneic mesenchymal stem cells (MSCs), Normal Saline
- Keywords
- DFU, Stem cells, Per-ulcer
- Medical subject headings
- Diabetic Foot
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Allogeneic mesenchymal stem cells (MSCs)Drug
Also called Ex-vivo cultured allogeneic mesenchymal stem cells (MSCs) supplied in vials consisting of 3 million cells, suspended in 1.5 ml saline.
Dosage · Dosing of IMP is based on ulcer size. The recommended dose is 1 million cells/cm2 of ulcer. Administration · Injections will be done through peri-ulcer route. · Injection will be done 0.75 cm from the edge of the ulcer. · Injection will be done using 24G. The volume of injection will 4.0 - 6.0 ml per patient (maximum 0.1 to 0.2 ml per injection; 30 injections maximum per patients)
Normal SalineDrug
Also called Placebo (Normal Saline)
Dosage · Dosing of placebo is based on ulcer size. the volume will be samed as the experimental groups which is 2 ml per 1cm2 Administration · Injections will be done through peri-ulcer route. · Injection will be done 0.75 cm from the edge of the ulcer. · Injection will be done using 24G. The volume of injection will 4.0 - 6.0 ml per patient (maximum 0.1 to 0.2 ml per injection; 30 injections maximum per patients)
| Study group | Role | What they receive |
|---|---|---|
| Allogeneic mesenchymal stem cells (MSCs) | Experimental | Peri-ulcer injection of Umbilical cord MSC (1.0 million cells/cm2 of the ulcer) will be administered at multiple sites (maximum of 30 sites) with intervals of 3 cm x 3 cm around the ulcer with total volume of 0.1 to 0.2 ml per injection. Whatever IMP is drawn into the syringe for administration to the wound must be completely dispensed and nothing should be left in the syringe. Number of injections and volume of each injection can be as per Investigator's discretion. The same to be recorded in the source notes and CRF.The injection will be done approximately using a 24G needle and 1 ml/3ml syringe approximately within 0.75 cm from the edge of the ulcer. The needle should enter the base of the ulcer from the edge. After injection, patients must be in a lying down position for at least one hour in daycare center at the site and monitoring of oxygen saturation will be done up to 2 hours ± 10 minutes after the administration of the product. Receives: Drug: Allogeneic mesenchymal stem cells (MSCs) |
| Normal Saline | Placebo comparator | The blinded placebo group will be injected with normal saline (NSand the volume to be injected is similar to the area of ulcer (2 mL of normal saline per 1 cm2 of ulcer). each injection will be o.1 to 0.2 ml normal saline (maximum injection will be 30 injection peri ulcer) Receives: Drug: Normal Saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of patients with complete healing/closure of the target ulcer at any time during the 6-weeks period.
ulcer assessment (area and photograph)
Measured: The monitoring of ulcer healing progress will continue until week 6 after the administration of the investigational medicinal product (IMP). The primary measure of effectiveness will be evaluated during the 8th visit which will take place at week 6.
Secondary outcomes (4)
The proportion of patients with sustained complete closure for additional 6-weeks of follow-up.
ulcer assessment (area and photograph)
Measured: weekly follow up 4 times, followed by biweekly followed up two times and one monthly follow up (weeks 12)
Time to complete closure of target ulcer.
ulcer assessment (area and photograph)
Measured: weekly follow up 4 times, followed by biweekly followed up two times and one monthly follow up (weeks 12)
Rate of reduction in the size of the target ulcer during the 6 weeks of follow-up.
ulcer assessment (area and photograph)
Measured: weekly follow up 4 times, followed by biweekly followed up two times and one monthly follow up (weeks 12)
The proportion of patients with at least 50% closure of target ulcer during the 6-weeks period
ulcer assessment (area and photograph)
Measured: weekly follow up 4 times, followed by biweekly followed up two times and one monthly follow up (weeks 12)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2024
- Study startMay 2024 (estimated)
- Primary completionOct 2024 (estimated)
- Study completion30 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetic Foot 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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Dosage · Dosing of IMP is based on ulcer size. The recommended dose is 1 million cells/cm2 of ulcer. Administration · Injections will be done through peri-ulcer route. · Injection will be done 0.75 cm from the edge of the ulcer. · Injection will be done using 24G. The volume of injection will 4.0 - 6.0 ml per patient (maximum 0.1 to 0.2 ml per injection; 30 injections maximum per patients) Dosage · Dosing of placebo is based on ulcer size. the volume will be same as the experimental groups which is 2 ml per 1cm2 Administration · Injections will be done through peri-ulcer route. · Injection will be done 0.75 cm from the edge of the ulcer. · Injection will be done using 24G. The volume of injection will 4.0 - 6.0 ml per patient (maximum 0.1 to 0.2 ml per injection; 30 injections maximum per patients)
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 22 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Supergenics Life Science Sdn. Bhd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Mohd Yazid Bajuri, Principal investigator, Hospital Canselor Tunku Muhriz (HCTM)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06231771
- Sponsor's protocol ID
- SGT-DFU-23-001
- Status last verified
- Mar 2024
- First submitted
- 21 Jan 2024
- Last updated
- 6 Mar 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double Blind, Placebo Controlled, Phase I/II Study Assessing the Efficacy and Safety of Peri-Ulcer Administration of Wharton-Jelly Mesenchymal Stem Cells in Patients With Non-Healing Diabetic Foot Ulcer
- ClinicalTrials.gov ID
- NCT06231771
- Acronym / sponsor ID
- SGT-DFU-23-001
- Conditions
- Diabetic Foot Ulcer
- Keywords
- DFU, Stem cells, Per-ulcer
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 22 participants (estimated)
- Lead sponsor
- Supergenics Life Science Sdn. Bhd.Industry (pharma, biotech, devices)
- Study start
- May 2024 (estimated)
- Primary completion
- Oct 2024 (estimated)
- Study completion
- 30 Dec 2024 (estimated)
- First posted
- 30 Jan 2024 (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.
The objective of this clinical trial is to evaluate the effectiveness and safety of Wharton-Jelly mesenchymal stem cells administered around the ulcer site in patients with nonhealing diabetic foot ulcers. The key inquiries it seeks to address include the percentage of patients achieving complete healing/closure of the specified ulcer at any point during the 6-week period, the duration required for the complete closure of the target ulcer, and the nature and occurrence of adverse events (AEs), along with the total number of AEs and the proportion of patients experiencing AEs.
Patients meeting the eligibility criteria will receive either allogeneic mesenchymal stromal cells (MSC) or a placebo. The peri-ulcer injection of umbilical cord MSC or placebo will be administered at multiple locations, around the ulcer. Subsequent follow-up after the administration of umbilical cord MSC or placebo will be conducted to monitor and observe the progress of ulcer healing.
Detailed description
Research involving MSCs promises new treatments and possible cures for many chronic and debilitating diseases. It has been shown that MSCs could be an effective therapy for many diseases, including CLI, AMI, OA of the knee, LC and DFU. No significant side effects have been reported with allogeneic MSC therapy in preclinical and clinical studies. Also, the potential benefits of MSC technology are compelling and worthy of pursuit in accordance with the appropriate ethical standards and regulatory guidelines. Both basic and clinical research suggest that allogeneic MSCs are likely to solve many unmet clinical needs, and this can be made available as an off-the-shelf product. the injective if this study was to evaluate the efficacy of peri-ulcer administration of Umbilical cord MSC in the healing of DFU and assess the safety of peri-ulcer administration of Umbilical cord MSC in DFU by assess the • Proportion of patients with complete healing/closure of the target ulcer at any time during the 6-weeks period and proportion of patients with sustained complete closure for additional 6-weeks of follow-up. besides that, this study also will assess the time to complete closure of target ulcer and rate of reduction in the size of the target ulcer during the 6 weeks of follow-up and proportion of patients with at least 50% closure of target ulcer during the 6-weeks period. this study is Double-blind, placebo-controlled, randomized trial. Estimated duration for the main protocol (e.g., from starts of screening to last subject processed and end of the study) is approximately 9 months at Hospital Canselor Tunku Muhriz (HCTM), Jalan Yaacob Latif, Bandar Tun Razak, 56000 Kuala Lumpur, Wilayah Persekutuan, Malaysia using Ex-vivo cultured allogeneic mesenchymal stem cells (MSCs) supplied in vials consisting of 3 million cells, suspended in 1.5 ml saline (3 million cells/1.5 mL) with dosage of 1 million cells/cm2 of ulcer. The administration of the product will be through the peri-ulcer route. The injection will be done using a 24G needle and 1 ml/3 ml syringe approximately within 0.75 cm from the edge of the ulcer. The needle should enter the base of the ulcer from the edge.
Injection of Umbilical cord MSC (1 million cells/cm2 of the ulcer) will be administered at multiple sites (maximum of 30 sites) with intervals of 3 cm x 3 cm around the ulcer in a total volume of 0.1 to 0.2 ml per injection.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Dosage · Dosing of IMP is based on ulcer size. The recommended dose is 1 million cells/cm2 of ulcer. Administration · Injections will be done through peri-ulcer route. · Injection will be done 0.75 cm from the edge of the ulcer. · Injection will be done using 24G. The volume of injection will 4.0 - 6.0 ml per patient (maximum 0.1 to 0.2 ml per injection; 30 injections maximum per patients) Dosage · Dosing of placebo is based on ulcer size. the volume will be same as the experimental groups which is 2 ml per 1cm2 Administration · Injections will be done through peri-ulcer route. · Injection will be done 0.75 cm from the edge of the ulcer. · Injection will be done using 24G. The volume of injection will 4.0 - 6.0 ml per patient (maximum 0.1 to 0.2 ml per injection; 30 injections maximum per patients)
| Arm | Type | Receives |
|---|---|---|
| Allogeneic mesenchymal stem cells (MSCs) | Experimental | Drug: Allogeneic mesenchymal stem cells (MSCs)Peri-ulcer injection of Umbilical cord MSC (1.0 million cells/cm2 of the ulcer) will be administered at multiple sites (maximum of 30 sites) with intervals of 3 cm x 3 cm around the ulcer with total volume of 0.1 to 0.2 ml per injection. Whatever IMP is drawn into the syringe for administration to the wound must be completely dispensed and nothing should be left in the syringe. Number of injections and volume of each injection can be as per Investigator's discretion. The same to be recorded in the source notes and CRF.The injection will be done approximately using a 24G needle and 1 ml/3ml syringe approximately within 0.75 cm from the edge of the ulcer. The needle should enter the base of the ulcer from the edge. After injection, patients must be in a lying down position for at least one hour in daycare center at the site and monitoring of oxygen saturation will be done up to 2 hours ± 10 minutes after the administration of the product. |
| Normal Saline | Placebo comparator | Drug: Normal SalineThe blinded placebo group will be injected with normal saline (NSand the volume to be injected is similar to the area of ulcer (2 mL of normal saline per 1 cm2 of ulcer). each injection will be o.1 to 0.2 ml normal saline (maximum injection will be 30 injection peri ulcer) |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Patients between 18-70 years old.
- Patients have type 2 diabetes mellitus
- Patients with HbA1c, less than or equal to 10%.
- Patients who were presented with an ulcer size between 8 to 12 cm2, have been diagnosed as full-thickness DFU.
- Adequate vascular perfusion (ABI ≥ 0.7 and < 1.3)
Key exclusion criteria (4 listed)
- Patients who are not diabetic.
- Patients with 2 or more ulcers.
- Patients with a history of participating in another stem cells trial or therapy within 3 months.
- Patients who are unsuitable to participate the clinical trial as determined by Investigators.
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 |
|---|---|---|
| Allogeneic mesenchymal stem cells (MSCs)Also: Ex-vivo cultured allogeneic mesenchymal stem cells (MSCs) supplied in vials consisting of 3 million cells, suspended in 1.5 ml saline.Dosage · Dosing of IMP is based on ulcer size. The recommended dose is 1 million cells/cm2 of ulcer. Administration · Injections will be done through peri-ulcer route. · Injection will be done 0.75 cm from the edge of the ulcer. · Injection will be done using 24G. The volume of injection will 4.0 - 6.0 ml per patient (maximum 0.1 to 0.2 ml per injection; 30 injections maximum per patients) | Drug | Allogeneic mesenchymal stem cells (MSCs) |
| Normal SalineAlso: Placebo (Normal Saline)Dosage · Dosing of placebo is based on ulcer size. the volume will be samed as the experimental groups which is 2 ml per 1cm2 Administration · Injections will be done through peri-ulcer route. · Injection will be done 0.75 cm from the edge of the ulcer. · Injection will be done using 24G. The volume of injection will 4.0 - 6.0 ml per patient (maximum 0.1 to 0.2 ml per injection; 30 injections maximum per patients) | Drug | Normal Saline |
Primary outcome
Proportion of patients with complete healing/closure of the target ulcer at any time during the 6-weeks period.
Time frame: The monitoring of ulcer healing progress will continue until week 6 after the administration of the investigational medicinal product (IMP). The primary measure of effectiveness will be evaluated during the 8th visit which will take place at week 6.
ulcer assessment (area and photograph)
4 secondary outcomes
The proportion of patients with sustained complete closure for additional 6-weeks of follow-up.
Time frame: weekly follow up 4 times, followed by biweekly followed up two times and one monthly follow up (weeks 12)
Time to complete closure of target ulcer.
Time frame: weekly follow up 4 times, followed by biweekly followed up two times and one monthly follow up (weeks 12)
Rate of reduction in the size of the target ulcer during the 6 weeks of follow-up.
Time frame: weekly follow up 4 times, followed by biweekly followed up two times and one monthly follow up (weeks 12)
The proportion of patients with at least 50% closure of target ulcer during the 6-weeks period
Time frame: weekly follow up 4 times, followed by biweekly followed up two times and one monthly follow up (weeks 12)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Mar 2024.
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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.
Mohd Yazid Bajuri principal investigator
Hospital Canselor Tunku Muhriz (HCTM)
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Allogeneic mesenchymal stem cells (MSCs) and Normal Saline in people with Diabetic Foot Ulcer, run by Supergenics Life Science Sdn. Bhd..
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 6 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 6 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined 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.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Abid Nordin (+6012-712 2468, abid@medcentral.com.my), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of patients with complete healing/closure of the target ulcer at any time during the 6-weeks period. (time frame: The monitoring of ulcer healing progress will continue until week 6 after the administration of the investigational medicinal product (IMP). The primary measure of effectiveness will be evaluated during the 8th visit which will take place at week 6.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 6 Mar 2024.