A study on cord blood stem cells and platelet-rich plasma for treating pregnancy stretch marks
| ISRCTN | ISRCTN17235665 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN17235665 |
- Submission date
- 01/11/2021
- Registration date
- 09/11/2021
- Last edited
- 05/11/2021
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Skin and Connective Tissue Diseases
Plain English Summary
Background and study aims:
Pregnancy stretch marks (striae gravidarum) are very common among pregnant women and may cause emotional and psychological stress. Current treatments, however, are not satisfactory. As cord blood-derived platelet-rich plasma (PRP) gel and stem cells have good regenerative capabilities, many studies have found the combination works well in cosmetic applications. The aim of this study is to test the effectiveness of PRP stem cell therapy at treating pregnancy stretch marks.
Who can participate?
Pregnant women aged 23 to 30 who have pregnancy stretch marks
What does the study involve?
Participants have their cord blood collected when giving birth. The collected blood provides the PRP and stem cells used later. The left abdomen of each participant receives no treatment. The right abdomen of each participant is treated with PRP stem cell injections on day 1, day 10, and day 20 after giving birth. The research staff will take photos of the abdomen to see how well the treatment works as time progresses.
What are the possible benefits and risks of participating?
The possible benefits include a safe and effective treatment of the stretch marks and tolerance for cell therapy. The risks involve the body reacting badly to the transplantation (it is not very probable since the materials used are from one’s own body).
Where is the study run from?
Shenyang Maternal and Child Care Service Center, Shenyang, Liaoning (China)
When is the study starting and how long is it expected to run for?
October 2021 to June 2023
Who is funding the study?
Shenyang Engineering Technology R&D Center of Cell Therapy Co., Ltd. (China)
Who is the main contact?
1. Dr Ning Pei
775104436@qq.com
2. Prof. Yanqiu Yu
yqyu@cmu.edu.cn
3. Dr Jing Li
820367546@qq.com
Contact information
Scientific
No.41 Shenzhou Rd
Heping District
Shenyang
110004
China
| Phone | +86 (0)24 13066597504 |
|---|---|
| 775104436@qq.com |
Scientific
Shenyang Engineering Technology R&D Center of Cell Therapy Co., Ltd
A10,400-8 wisdom Second Street
Hunnan District
Shenyang
110004
China
| Phone | +86 (0)24 13386887215 |
|---|---|
| yqyu@cmu.edu.cn |
Public
Shenyang Engineering Technology R&D Center of Cell Therapy Co., Ltd
A10,400-8 wisdom Second Street
Hunnan District
Shenyang
110004
China
| Phone | +86 (0)24 15142525031 |
|---|---|
| yutong@sycellcenter.com |
Scientific
No.41 Shenzhou Rd, Heping District
Shenyang
110004
China
| Phone | +86 (0)24 13998160669 |
|---|---|
| 820367546@qq.com |
Study information
| Study design | Single-center non-randomized study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Non randomised study |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | No participant information sheet available |
| Scientific title | The effect of autologous umbilical cord blood stem cells and platelet-rich plasma on striae gravidarum |
| Study acronym | PRPPSM |
| Study hypothesis | The combination of cord blood-derived autologous platelet-rich plasma (PRP) gel and stem cells is effective in treating striae gravidarum. |
| Ethics approval(s) | Approved 29/10/2021, Institutional Review Board of the Shenyang Maternal and Child Care Service Center (No.41 Shenzhou Rd, Heping District, Shenyang, China; +86 (024)86906168; 775104436@qq.com), ref: 2021-001-01 |
| Condition | Striae gravidarum |
| Intervention | Control group: left abdomen of each participant, no treatment. Intervention group: right abdomen of each participant, PRP stem cell transplantation. Transplantation: 1×10^7 autologous cord blood stem cells and 15 ml autologous PRP gel, administered via subcutaneous injection at the site of the striae gravidarum. Three transplantations are planned at Day 1, 10, and 20 post-delivery. Additional procedures: 1. Before the injection: Apply lidocaine cream at the injection site beforehand to reduce pain caused by the puncture 2. During and immediately after the injection: 1. Apply manual pressure at the injection area for an extended period to reduce bleeding 2. Apply cold compress at the injection area to prevent bruise 3. In case of a bruise, at 48 h post-transplantation: Apply hot compress at the bruised area to facilitate absorption |
| Intervention type | Biological/Vaccine |
| Pharmaceutical study type(s) | |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | |
| Primary outcome measure | Visual changes measured using abdomen photos at baseline, the 7th day after each transplantation (i.e., day 8, 17, and 27 post-delivery), month 2, and month 3 post-delivery |
| Secondary outcome measures | Measured at baseline, day 8, 17, 27, month 2, and month 3 post-delivery: 1. Pain caused by striae gravidarum measured using self-reporting questionnaires 2. Pruritus caused by striae gravidarum measured using self-reporting questionnaires |
| Overall study start date | 01/10/2021 |
| Overall study end date | 30/06/2023 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Female |
| Target number of participants | 10 |
| Participant inclusion criteria | 1. Pregnant women with striae gravidarum 2. Full-term or cesarean delivery 3. Aged 23 to 30 years |
| Participant exclusion criteria | 1. Participant in other ongoing clinical trials 2. Tested positive for hepatitis B, hepatitis C, HIV, syphilis, EBV, or CMV 3. History of severe allergic reactions or adverse reactions to medication |
| Recruitment start date | 15/11/2021 |
| Recruitment end date | 14/11/2022 |
Locations
Countries of recruitment
- China
Study participating centre
Heping District
Shenyang
110004
China
Sponsor information
Hospital/treatment centre
No.41 Shenzhou Rd
Heping District
Shenyang
110004
China
| Phone | +86 (0)2486906168 |
|---|---|
| syfykj2011@163.com | |
| Website | http://sysfybjy.net/index.php?g=&m=Index&a=index |
Industry
A10, 400-8 wisdom Second Street
Hunnan District
Shenyang
110004
China
| Phone | +86 (0)15142525031 |
|---|---|
| shenyangcell@163.com | |
| Website | http://www.sycellcenter.com/index.php/cn/Index/index.html |
Funders
Funder type
Industry
No information available
Results and Publications
| Intention to publish date | 31/12/2022 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Data sharing statement to be made available at a later date |
| Publication and dissemination plan | Planned publication in a high-impact peer-reviewed journal |
| IPD sharing plan | The data-sharing plans for the current study are unknown and will be made available at a later date. |
Editorial Notes
04/11/2021: Trial's existence confirmed by the Institutional Review Board of the Shenyang Maternal and Child Care Service Center.
