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.
연구 개요
상태
상태
정황
정황
개입 / 치료
개입 / 치료
연구 유형
연구 유형
등록 (추정된)
등록
단계
단계
- 초기 1단계
참여기준
자격 기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
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.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위화되지 않음
- 중재 모델: 순차적 할당
- 마스킹: 삼루타
팔의 수
무기와 개입
참가자 그룹 / 팔참가자 그룹 / 팔 |
개입 / 치료개입 / 치료 |
|---|---|
|
실험적: 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. |
|
위약 비교기: 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. |
연구는 무엇을 측정합니까?
주요 결과 측정
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Adverse reaction grade
기간: From the beginning of the treatment to 28 days after the treatment.
|
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.
|
|
Adverse reaction grade
기간: 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.
|
|
Adverse reaction grade
기간: 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.
|
|
Adverse reaction grade
기간: 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.
|
2차 결과 측정
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Clinical effectiveness
기간: 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
|
|
Clinical effectiveness
기간: 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
|
|
Clinical effectiveness
기간: 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
|
|
Clinical effectiveness
기간: 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
|
공동 작업자 및 조사자
연구 기록 날짜
연구 주요 날짜
연구 시작 (추정된)
연구 시작
기본 완료 (추정된)
기본 완료
연구 완료 (추정된)
연구 완료
연구 등록 날짜
최초 제출
최초 제출
QC 기준을 충족하는 최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
처음 게시됨
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
마지막 업데이트 게시됨
QC 기준을 충족하는 마지막 업데이트 제출
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
기타 연구 ID 번호
기타 연구 ID 번호
- 2026BJYYEC-XJS001
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
IPD 공유 지원 정보 유형
- CSR
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