Intracapsular Injection of Human Umbilical Cord Mesenchymal Stem Cells for the Treatment of Knee Osteoarthritis (KOA UC-MSCs)
Evaluating the Efficacy of Intra-articular Injection of Human Umbilical Cord Mesenchymal Stem Cells for Treating Knee Osteoarthritis
This is a self-controlled study comparing both knees. A total of 20 participants are planned to be enrolled. Among the first 10 participants, the same patient received 50 million mesenchymal stem cells and 2 ml of hyaluronic acid solution mixture in one knee as the experimental group, while the other knee was treated with 2 ml of hyaluronic acid injection solution as the control group. The first 10 patients did not experience any serious adverse events. After re-enrollment of the next 10 patients, the same patient was given 100 million mesenchymal stem cells and 2 ml of hyaluronic acid sodium mixture to one knee, while the other knee was given 2 ml of hyaluronic acid sodium injection as the experimental group. Compare the therapeutic effects between the two knees and among different doses.
Přehled studie
Postavení
Podmínky
Intervence / Léčba
Typ studie
Zápis (Odhadovaný)
Fáze
- Raná fáze 1
Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
Přijímá zdravé dobrovolníky
Pohlaví způsobilá ke studiu
Popis
Inclusion Criteria:
- Patients with primary knee osteoarthritis aged between 45 and 75 years old;
- The X-ray of the bilateral knee joints shows a KL grade of 2-3 for both knees, and the grades of the bilateral knee joints are consistent;
- The difference in knee pain VAS score between both knees is no more than 2 points;
Exclusion Criteria:
- Those who have received joint cavity injection treatment within 3 months;
- Those who have experienced knee joint infection within 12 weeks, or knee joint injury within 12 weeks;
- Rheumatoid arthritis and other autoimmune joint diseases;
- Those with digestive tract ulcers, coronary heart disease and other conditions where the use of non-steroidal anti-inflammatory drugs is contraindicated;
- Those with tumors, diabetes, blood system diseases, local skin diseases and systemic allergies;
- Those with immunodeficiency or who have received immunosuppressive treatment within 12 weeks;
- Those with other serious diseases that cannot cooperate with the study.
Studijní plán
Jak je studie koncipována?
Detaily designu
- Primární účel: Léčba
- Přidělení: Nerandomizované
- Intervenční model: Sekvenční přiřazení
- Maskování: Trojnásobný
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
|---|---|
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Experimentální: treatment group
First, 10 subjects were enrolled. For one knee joint of each subject, a mixture of 5 million HUCMSCs and 2 ml of sodium hyaluronate was administered as the experimental group. If no serious adverse reactions occurred among the first 10 patients, the remaining 10 subjects were enrolled, and the other knee joint of each subject was treated with 100 million HUCMSCs and 2 ml of sodium hyaluronate as the experimental group. |
Procedure for knee joint injection: The patient lies on their back, with the knee joint flexed at 90 degrees. The knee joint is disinfected with iodine and alcohol, and a sterile sheet is laid out. The puncture point for the knee joint is selected at the inner or outer knee crease or the supra-patellar bursa approach. Using a joint cavity puncture needle (a 19-gauge needle), insert the needle vertically through the skin at the puncture point. There is a slight sense of firmness when passing through the joint capsule, and a feeling of emptiness when it is broken through. There is no resistance when injecting the fluid, and the drug can be injected. |
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Komparátor placeba: control group
The control group was given 2 ml of sodium hyaluronate.The control group was given 2 ml of sodium hyaluronate. |
Procedure for knee joint injection: The patient lies on their back, with the knee joint flexed at 90 degrees. The knee joint is disinfected with iodine and alcohol, and a sterile sheet is laid out. The puncture point for the knee joint is selected at the inner or outer knee crease or the supra-patellar bursa approach. Using a joint cavity puncture needle (a 19-gauge needle), insert the needle vertically through the skin at the puncture point. There is a slight sense of firmness when passing through the joint capsule, and a feeling of emptiness when it is broken through. There is no resistance when injecting the fluid, and the drug can be injected. |
Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Adverse reaction grade
Časové okno: From the beginning of the treatment to 28 days after the treatment.
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Blood pressure was recorded during the transplantation process and on the 3rd, 7th, 14th and 28th days after the transplantation. |
From the beginning of the treatment to 28 days after the treatment.
|
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Adverse reaction grade
Časové okno: From the beginning of the treatment to 28 days after the treatment.
|
During the transplantation process and on the 3rd, 7th, 14th and 28th days after transplantation, record the heart rate. |
From the beginning of the treatment to 28 days after the treatment.
|
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Adverse reaction grade
Časové okno: From the beginning of the treatment to 28 days after the treatment.
|
During the transplantation process and on the 3rd, 7th, 14th and 28th days after transplantation, record the body temperature. |
From the beginning of the treatment to 28 days after the treatment.
|
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Adverse reaction grade
Časové okno: From the beginning of the treatment to 28 days after the treatment.
|
During the transplantation process and on the 3rd, 7th, 14th and 28th days after transplantation, observe whether any rash occurs. |
From the beginning of the treatment to 28 days after the treatment.
|
Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Clinical effectiveness
Časové okno: From the beginning of the treatment to two years after the treatment
|
patient pain score (VAS score)： 0 point: Completely pain-free, no discomfort. 1-3 points (mild): There is pain, but it does not affect sleep or daily activities and can be tolerated; 4-6 points (moderate): Severe pain that significantly affects sleep, requiring distraction to cope with it, and usually requiring medication intervention; 7-10 points (severe): Significantly interferes with daily life, unbearable, may result in inability to move or sleep, requires strong pain relief. |
From the beginning of the treatment to two years after the treatment
|
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Clinical effectiveness
Časové okno: From the beginning of the treatment to two years after the treatment
|
joint function score (KSS score) Including clinical scores and functional scores. |
From the beginning of the treatment to two years after the treatment
|
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Clinical effectiveness
Časové okno: From the beginning of the treatment to two years after the treatment
|
quality of life score (SF-12) |
From the beginning of the treatment to two years after the treatment
|
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Clinical effectiveness
Časové okno: From the beginning of the treatment to two years after the treatment
|
WORMS score |
From the beginning of the treatment to two years after the treatment
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Spolupracovníci a vyšetřovatelé
Sponzor
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Odhadovaný)
Primární dokončení (Odhadovaný)
Dokončení studie (Odhadovaný)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Aktuální)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Další relevantní podmínky MeSH
Další identifikační čísla studie
- 2026BJYYEC-XJS001
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Typ podpůrných informací pro sdílení IPD
- CSR
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