WoundsPhase 1/2SEESCMMSCTSDNCT02672280
Safety and Exploratory Efficacy Study of Collagen Membrane With Mesenchymal Stem Cells in the Treatment of Skin Defects
A Phase 1/2 study testing Medical Collagen Membrane with MSC and Medical Collagen Membrane in people with Wounds and Diabetic Foot Ulcers, run by South China Research Center for Stem Cell and Regenerative Medicine.
Trial summary
The purpose of the present study is to evaluate the safety and exploratory efficacy of the medical collagen membrane with umbilical cord derived mesenchymal stem cells in the treatment of patients with skin defects. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Wounds, Diabetic Foot Ulcers, Burns
- What is being tested?
- Medical Collagen Membrane with MSC and Medical Collagen Membrane
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- May 2016to Dec 2017
- 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
- Age between 18 and 70, borh gender.
- Patient able and willing to sign informed consent and comply with study procedures.
- Women of childbearing potential must use birth control pills, barriers or abstinence and have a negative pregnancy test.
- Deep partial or full thickness skin defect of at least 9 cm2 requiring surgical wound coverage due to: burn injury, diabetic foot ulcer or wounds caused by mechanical damage or iatrogenic injury.
Who cannot join
- Patient refusal.
- Patient has a documented history of allergy or sensitivity to any of the animal products used in preparation of skin substitute. These products include bovine blood, bovine collagen, and bovine collagenase.
- Patient has a documented history of allergy or sensitivity to any of the antimicrobials or reagents used in preparation and application of skin substitute including the irrigation solution used before and after grafting.
- Patient has a current diagnosis of an invasive burn wound infection in unexcised burn wound.
- Patient has tunnels or sinus tracts that cannot be completely debrided.
- Serious primary diseases of the liver, kidney and hematopoietic system, Abnormal liver function(glutamic-pyruvic transaminase(ALT), glutamicoxalacetic transaminase (AST) is 2 times higher than the normal value), creatinine(Cr) is higher than the upper limit of the normal value.
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- Other clinical trial participants within 3 months.
- A random blood sugar reading >/=450 mg/dL.
- Investigators judge other conditions not suitable for inclusion.
Trial locations and contacts
No sites are listed yet.
About this study
The purpose of the present study is to evaluate the safety and exploratory efficacy of the medical collagen membrane with umbilical cord derived mesenchymal stem cells in the treatment of patients with skin defects.
- Conditions
- Wounds, Diabetic Foot Ulcers, Burns
- Being tested
- Medical Collagen Membrane with MSC, Medical Collagen Membrane
- Medical subject headings
- Wounds and Injuries, Diabetic Foot, Burns
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Medical Collagen Membrane with MSCDevice
Medical Collagen MembraneDevice
| Study group | Role | What they receive |
|---|---|---|
| Medical Collagen Membrane with MSC | Experimental | Applications of medical collagen membrane with umbilical cord derived mesenchymal stem cells (MSC). Receives: Device: Medical Collagen Membrane with MSC |
| Medical Collagen Membrane | Active comparator | Application of medical collagen membrane only. Receives: Device: Medical Collagen Membrane |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of adverse events that are related to study treatment and associated with the grafting site
Measured: Up to Month 36 after the last grafting day
Percentage of wound closure as determined
Measured: Up to Month 3 after the last grafting day
Secondary outcomes (7)
Scar outcome assessment
Measured: Up to Month 36 after the last grafting day
Incidence of contracture release or revision surgeries
Measured: Up to Month 36 after the last grafting day
Incidence of increased temperature sensitivity
Measured: Up to Month 36 after the last grafting day
Incidence of paresthesias, pain, dulling of sensation assessed
Measured: Up to Month 36 after the last grafting day
Incidence and severity of infections at grafting sites
Measured: Up to Month 6 after the last grafting day
Incidence of all adverse events
Measured: Up to Month 36 after the last grafting day
Percentage area of re-grafting as determined
Measured: Up to Month 6 after the last grafting day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Feb 2016 (estimated)
- Study startMay 2016
- Primary completionDec 2017 (estimated)
- Study completionDec 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for WoundsStudies 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
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- South China Research Center for Stem Cell and Regenerative Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02672280
- Sponsor's protocol ID
- UCMSC-3
- Acronym
- SEESCMMSCTSD
- Status last verified
- Jan 2016
- First submitted
- 31 Jan 2016
- Last updated
- 3 Feb 2016
- Results posted
- No
- Individual data sharing
- Undecided
Publications
He L, Nan X, Wang Y, Guan L, Bai C, Shi S, Yuan H, Chen L, Liu D, Pei X. Full-thickness tissue engineered skin constructed with autogenic bone marrow mesenchymal stem cells. Sci China C Life Sci. 2007 Aug;50(4):429-37. doi: 10.1007/s11427-007-0069-2.
PubMed 17653662
Study at a glance
From the registry record, last updated by the sponsor on 3 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Exploratory Efficacy Study of Collagen Membrane With Mesenchymal Stem Cells in the Treatment of Skin Defects
- ClinicalTrials.gov ID
- NCT02672280
- Acronym / sponsor ID
- SEESCMMSCTSD / UCMSC-3
- Conditions
- Wounds, Diabetic Foot Ulcers, Burns
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- South China Research Center for Stem Cell and Regenerative MedicineUniversity, hospital or other
- Study start
- May 2016
- Primary completion
- Dec 2017 (estimated)
- Study completion
- Dec 2017 (estimated)
- First posted
- 3 Feb 2016 (estimated)
- 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 purpose of the present study is to evaluate the safety and exploratory efficacy of the medical collagen membrane with umbilical cord derived mesenchymal stem cells in the treatment of patients with skin defects.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Medical Collagen Membrane with MSC | Experimental | Device: Medical Collagen Membrane with MSCApplications of medical collagen membrane with umbilical cord derived mesenchymal stem cells (MSC). |
| Medical Collagen Membrane | Active comparator | Device: Medical Collagen MembraneApplication of medical collagen membrane only. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age between 18 and 70, borh gender.
- Patient able and willing to sign informed consent and comply with study procedures.
- Women of childbearing potential must use birth control pills, barriers or abstinence and have a negative pregnancy test.
- Deep partial or full thickness skin defect of at least 9 cm2 requiring surgical wound coverage due to: burn injury, diabetic foot ulcer or wounds caused by mechanical damage or iatrogenic injury.
Key exclusion criteria (9 listed)
- Patient refusal.
- Patient has a documented history of allergy or sensitivity to any of the animal products used in preparation of skin substitute. These products include bovine blood, bovine collagen, and bovine collagenase.
- Patient has a documented history of allergy or sensitivity to any of the antimicrobials or reagents used in preparation and application of skin substitute including the irrigation solution used before and after grafting.
- Patient has a current diagnosis of an invasive burn wound infection in unexcised burn wound.
- Patient has tunnels or sinus tracts that cannot be completely debrided.
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 |
|---|---|---|
| Medical Collagen Membrane with MSC | Device | Medical Collagen Membrane with MSC |
| Medical Collagen Membrane | Device | Medical Collagen Membrane |
Primary outcome
Incidence of adverse events that are related to study treatment and associated with the grafting site
Time frame: Up to Month 36 after the last grafting day
Percentage of wound closure as determined
Time frame: Up to Month 3 after the last grafting day
7 secondary outcomes
Scar outcome assessment
Time frame: Up to Month 36 after the last grafting day
Incidence of contracture release or revision surgeries
Time frame: Up to Month 36 after the last grafting day
Incidence of increased temperature sensitivity
Time frame: Up to Month 36 after the last grafting day
Incidence of paresthesias, pain, dulling of sensation assessed
Time frame: Up to Month 36 after the last grafting day
Incidence and severity of infections at grafting sites
Time frame: Up to Month 6 after the last grafting day
Incidence of all adverse events
Time frame: Up to Month 36 after the last grafting day
Percentage area of re-grafting as determined
Time frame: Up to Month 6 after the last grafting day
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Feb 2016.
- Background: PubMed 17653662He L, Nan X, Wang Y, Guan L, Bai C, Shi S, Yuan H, Chen L, Liu D, Pei X. Full-thickness tissue engineered skin constructed with autogenic bone marrow mesenchymal stem cells. Sci China C Life Sci. 2007 Aug;50(4):429-37. doi: 10.1007/s11427-007-0069-2.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided
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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.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Medical Collagen Membrane with MSC and Medical Collagen Membrane in people with Wounds and Diabetic Foot Ulcers, run by South China Research Center for Stem Cell and Regenerative Medicine.
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 4 inclusion and 9 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 3 Feb 2016. 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. 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 Xuetao Pei, M.D., Ph.D (0086-10-68164807, peixuetao@scrm.org.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of adverse events that are related to study treatment and associated with the grafting site (time frame: Up to Month 36 after the last grafting day). The study lists 2 primary outcomes in all. 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 NCT02672280, which also lists 1 linked publication.
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 3 Feb 2016.