A Phase 1/2 interventional study of stromal vascular fraction and saline in Skin; Deformity, Due to Scar, sponsored by Shanghai Jiao Tong University School of Medicine. Status unknown at 1 site in China. Open to participants aged 3 Years to 70 Years. Per ClinicalTrials.gov, last updated 2015-09-11.
Sponsored by Shanghai Jiao Tong University School of Medicine · Phase 1/2, Interventional, and Treatment
Among 25 studies in Congenital Abnormalities with a site in China — 4 open to participants now, 9 under way, none of them phase 3. Congenital Abnormalities · China.
Among the 25 studies in Congenital Abnormalities with a site in China, this one is one of 4 that started in 2015, is the only one in phase 1/2, and was the 2nd registered.
781 studies on the registry are indexed under Congenital Abnormalities; 77 are open to participants now.
This study's planned enrollment of 75 is above the median of 40 across 466 interventional studies indexed under Congenital Abnormalities.
Browse Congenital Abnormalities studies →4 of the 25 studies in Congenital Abnormalities with a site in China are open now, in 1 country. Each count lists the studies.
Of the 60 Congenital Abnormalities studies recruiting now, 27 (45%) set no upper age limit and 27 (45%) stop at 75 or younger; 35 take children under 18; 22 take healthy volunteers.
This study: 3 Years to 70 Years · all sexes · no healthy volunteers.
The full table on the hub →25 studies; the count open now beside each. This study's row is marked.
First in 2013; this study’s year is marked. 4 started in 2015.
Median enrollment 75 across the 5 interventional studies, 3,449 across the 20 observational. Of the 10 that completed or were terminated, 1 (10%) have results posted.
2 of 25 have an industry lead sponsor. The 10 most frequent:
Shanghai Jiao Tong University School of Medicine is the lead sponsor of 374 studies on the registry; 110 are open to participants now.
Shanghai Jiao Tong University School of Medicine has 1 study filed under Congenital Abnormalities — fewer than ten, so there is no comparison to draw.
1 of the studies in Congenital Abnormalities with a site in China that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT03931707Children's Hospital of Fudan UniversityThe China Neonatal Genomes Project | 2026-12-30 |
Among the 25 studies in Congenital Abnormalities with a site in China, from their registry updates:
Nothing recorded among them since 2026-09-25.
The purpose of this study is to observe whether the transplantation of autologous stromal vascular fraction (SVF) in adipose tissue is safe and its effect on improving the texture and contracture of skin grafting.
Reconstruction of large scale skin defect is still a challenge for clinical surgeons. The application of skin grafting works as an important choice, however, the strong contracture and poor appearance limit its wide application in scar repair. The stromal vascular fraction (SVF) of adipose tissue is a group of heterogeneous cells including multipotential mesenchymal cells, preadipocytes, endothelial cells, fibroblasts, macrophages and smooth muscle cells. Previous researches have reported that SVF could secrete various angiogenic growth factors in vitro and enhance neovascularisation of ischaemic tissue in vivo. The Adipose-derived Stem cells in the SVF are multipotential stem cells which have the ability to regenerate, while differentiating to become adipose tissue and help to improve the texture of the grafted skin. Besides, SVF is easy to be harvested in large numbers with less donor injury and can be used directly after isolation without in vitro culture, which makes it a good alternative for regenerative medicine.This study is to observe the effect of autologous SVF on improving the texture and contracture of skin grafting.
Patients requiring skin graft of 2 symmetry parts of the body between the age of 3 and 70 years will be enrolled and randomized into two groups, named as the experimental group with SVF transplantation and the control group with no cell transplantation. Patients from the experimental group will have a fat aspiration on the surgery day. The adipose tissue in abdomen or thigh will be digested at 37 °C for 60 min with 0.2% collagenase IV. After filtration and centrifugation, mature adipocytes are separated from the cell pellet. The pellet then is treated with erythrocyte lysis buffer twice to remove red cell fragment. The harvested pellet is SVF. The SVF will be resuspended in saline and transplanted between the grafted skin and the wound with 1 million cells for 1 cm2 area. Skin thickness, texture, contracture and colour will be observed to measure the effect of SVF on skin grafting post treatment.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Hepatitis B tests
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The adipose tissue in abdomen or thigh will be harvested and digested at 37 °C for 60 min with 0.2% collagenase I/Ⅲ. After filtration and centrifugation, mature adipocytes are separated from the cell pellet. The pellet then is treated with erythrocyte lysis buffer twice to remove red cell fragment. The harvested pellet is stromal vascular fraction (SVF).
Biological: stromal vascular fraction
1 ml saline without cells will be used as placebo.
Drug: saline
1million stromal vascular fraction was resuspended in 1 ml saline and transplanted for 1 cm2 area.
Also known as: heterogeneous cell populations isolated from adipose tissue
1 ml saline was injected for 1 cm2 area.
Also known as: normal saline
Measure the texture and colour change of the skin using Cutometer® dual MPA 580 and questionnaires in 6 months post the treatment.
Questionnaires scores satisfaction range from 0(not satisfied with the result) to 10(good result)
Time frame: 6 months post the treatment.
Occurence of major adverse events
Including skin graft ischaemia, necrosis, infection, and all other adverse events
Time frame: Up to approximately 18 months after study start
The record gives a start of Feb 2015, a primary completion of Jun 2016 and a completion of Dec 2016. It does not say whether these dates are actual or estimated.
How these figures are worked out, and which studies are left out of them.
This study is status unknown, as verified in Sep 2015. You cannot join it, but the record below documents what was studied.
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Shanghai Jiao Tong University School of Medicine →