Preparation process of allogenic human adipose-derived mesenchymal stem cell injection
By using the patient's own fat to separate and purify and expand the germinated stem cells between the fat, it is prepared to be prepared into the form of injection, which solves the problem of large trauma and high recurrence rate in the treatment of perianal fistula. Low -rate treatment effect.
Patent Information
- Application Number
- CN202310908744.2
- Authority / Receiving Office
- CN · China
- Patent Type
- Applications(China)
- Current Assignee / Owner
- Filing Date
- 2023-07-24
- Publication Date
- 2025-01-24
AI Technical Summary
Perianal fistula is a common complication of Crohn's disease, with a high recurrence rate. Traditional treatments have problems such as heavy trauma, severe pain, and high recurrence rate. There is a lack of a new method that is safe and effective and can protect the function of the anal sphincter.
By using the patient to separate the fat and purify the germinal stem cells between the fat, the in vitro amplification is performed, and the amplified stem cells are mixed with the physiological saline, the release test and related verification are performed, and the body is finally returned to the body through the form of injection.
Adipose stem cell treatment for anal fistula has special advantages such as small trauma, no sphincter damage, mild pain, fast repair, low recurrence rate, and short hospitalization time, and has significantly improved the patient's quality of life.
Abstract
Description
Technical Field
[0001] The invention belongs to the technical field of biomedicine, and specifically relates to a preparation process of an allogeneic human adipose-derived mesenchymal stem cell injection. Background Art
[0002] Stem cells have great potential in treating various diseases. Adipose-Derived Stem Cells (ADSC) are a type of stem cell with multidirectional differentiation potential that has been isolated from adipose tissue in recent years. Studies have shown that 2% of cells in adipose tissue are adipose stem cells, which is much higher than the proportion obtained from bone marrow (0.002%). The proliferation rate of in vitro culture is higher than that of bone marrow stem cells. Adipose stem cells do not express NK receptor ligands and will not cause immune rejection reactions. Therefore, ADSCs show application prospects that other stem cells cannot achieve. Both autologous adipose stem cell (ADSC) transplantation and allogeneic ADSC transplantation for the treatment of anal fistula have special advantages such as less trauma, no sphincter damage, mild pain, fast repair, low recurrence rate, and short hospitalization time. The safety and effectiveness have been preliminarily certified, and its advantages are not available in traditional treatment methods such as surgery and minimally invasive treatments.
[0003] Perianal fistula is a common complication of Crohn's disease with a high recurrence rate. Symptoms such as pain, secretions, and incontinence seriously affect the quality of life and bring great pain to patients. A safe and effective new method that can protect the function of the anal sphincter is needed to replace traditional treatment. Although current antibiotics and immunosuppressive treatments can help promote fistula closure and maintain remission, some patients still need local surgical treatments such as drainage and hanging threads, or even rectal resection plus permanent stoma, due to failure of drug treatment. Summary of the invention
[0004] The present invention provides a preparation process of an allogeneic human adipose-derived mesenchymal stem cell injection, which is used for clinical application of stem cell therapy.
[0005] To achieve the above object, the present invention provides the following technical solutions:
[0006] A preparation process of allogeneic human adipose-derived mesenchymal stem cell injection comprises the following steps:
[0007] The steps include extracting fat from the patient to separate and purify stem cells, expanding the stem cells in vitro, and then passing release inspection and returning them to the site of administration in the body through surgery.
[0008] The method further comprises suspending the expanded stem cells in physiological saline, which can be stable for 48 hours at 4° C. or room temperature.
[0009] It also includes the steps of measuring surface markers and specific gene expression products by flow cytometry and PCR for relevant testing of mycoplasma release.
[0010] Compared with the prior art, the present invention has the following beneficial effects:
[0011] Relevant human clinical studies have shown that adipose stem cell treatment of anal fistula has special advantages such as less trauma, no sphincter damage, mild pain, rapid repair, low recurrence rate and short hospitalization time. DETAILED DESCRIPTION
[0012] The technical solutions in the embodiments of the present invention are described clearly and completely below. Obviously, the described embodiments are only part of the embodiments of the present invention, not all of them. Based on the embodiments of the present invention, all other embodiments obtained by ordinary technicians in this field without creative work are within the scope of protection of the present invention.
[0013] Example
[0014] A preparation process of allogeneic human adipose-derived mesenchymal stem cell injection comprises the following steps:
[0015] The steps include extracting fat from the patient to separate and purify stem cells, expanding the stem cells in vitro, and then passing release inspection and returning them to the site of administration in the body through surgery.
[0016] The method further comprises suspending the expanded stem cells in physiological saline, which can be stable for 48 hours at 4° C. or room temperature.
[0017] It also includes the steps of measuring surface markers and specific gene expression products by flow cytometry and PCR for relevant testing of mycoplasma release.
[0018] Relevant human clinical studies have shown that adipose stem cell treatment of anal fistula has special advantages such as less trauma, no sphincter damage, mild pain, rapid repair, low recurrence rate and short hospitalization time.
Claims
1. A preparation process for allogeneic human adipose-derived mesenchymal stem cell injection, characterized in that The steps include: The steps include extracting fat from the patient to separate and purify stem cells, expanding the stem cells in vitro, and then passing release inspection and returning them to the site of administration in the body through surgery.
2. The preparation process of the allogeneic human adipose-derived mesenchymal stem cell injection according to claim 1, characterized in that The method further comprises suspending the expanded stem cells in physiological saline, which can be stable for 48 hours at 4° C. or room temperature.
3. The preparation process of the allogeneic human adipose-derived mesenchymal stem cell injection according to claim 1, characterized in that The method also includes the steps of measuring surface markers and specific gene expression products by flow cytometry and performing relevant tests on the mycoplasma release by PCR.