Safety and Exploratory Efficacy Study of Collagen Membrane With Mesenchymal Stem Cells in the Treatment of Skin Defects (SEESCMMSCTSD)
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ClinicalTrials.gov Identifier: NCT02672280 |
Recruitment Status : Unknown
Verified January 2016 by South China Research Center for Stem Cell and Regenerative Medicine.
Recruitment status was: Not yet recruiting
First Posted : February 3, 2016
Last Update Posted : February 3, 2016
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Condition or disease | Intervention/treatment | Phase |
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Wounds Diabetic Foot Ulcers Burns | Device: Medical Collagen Membrane with MSC Device: Medical Collagen Membrane | Phase 1 Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 30 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Study Start Date : | May 2016 |
Estimated Primary Completion Date : | December 2017 |
Estimated Study Completion Date : | December 2017 |

Arm | Intervention/treatment |
---|---|
Experimental: Medical Collagen Membrane with MSC
Applications of medical collagen membrane with umbilical cord derived mesenchymal stem cells (MSC).
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Device: Medical Collagen Membrane with MSC |
Active Comparator: Medical Collagen Membrane
Application of medical collagen membrane only.
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Device: Medical Collagen Membrane |
- 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 ]
- 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 ]

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Ages Eligible for Study: | 18 Years to 70 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
- Other clinical trial participants within 3 months.
- A random blood sugar reading >/=450 mg/dL.
- Investigators judge other conditions not suitable for inclusion.

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): NCT02672280
Contact: Xuetao Pei, M.D., Ph.D | 0086-10-68164807 | peixuetao@scrm.org.cn | |
Contact: Bowen Zhang, Ph.D | 0086-10-66931947 | zhangbowen@scrm.org.cn |
Publications:
Responsible Party: | South China Research Center for Stem Cell and Regenerative Medicine |
ClinicalTrials.gov Identifier: | NCT02672280 |
Other Study ID Numbers: |
UCMSC-3 |
First Posted: | February 3, 2016 Key Record Dates |
Last Update Posted: | February 3, 2016 |
Last Verified: | January 2016 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | Undecided |
Diabetic Foot Foot Ulcer Diabetic Angiopathies Vascular Diseases Cardiovascular Diseases Leg Ulcer Skin Ulcer |
Skin Diseases Diabetes Complications Diabetes Mellitus Endocrine System Diseases Diabetic Neuropathies Foot Diseases |