Mesenchymal Stem Cell Transplantation for Osteoarthritis
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|ClinicalTrials.gov Identifier: NCT03969680|
Recruitment Status : Recruiting
First Posted : May 31, 2019
Last Update Posted : July 12, 2019
|Condition or disease||Intervention/treatment||Phase|
|Knee Osteoarthritis||Biological: Auotologous BMSCs plus autologous PRP Biological: Auotologous PRP||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||60 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||Autologous Mesenchymal Stem Cell Transplantation for the Treatment of Knee Osteoarthritis|
|Estimated Study Start Date :||July 1, 2019|
|Estimated Primary Completion Date :||December 31, 2019|
|Estimated Study Completion Date :||December 31, 2020|
Experimental: BMSCs plus PRP group
Three intra-articular injections in total and autologous bone marrow-derived mesenchymal stem cells (BMSCs) suspended in 3 ml autologous platelet rich plasma (PRP) for each injection. Time-points for intervention: 1) initial injection; 2) 3 months following initial injection; 3) 6 months following initial injection.
Biological: Auotologous BMSCs plus autologous PRP
30 mL of bone marrow will be aspirated from the iliac crests of patients in case group. BMSCs will be isolated from bone marrow and cultured. Before injection, 30 mL of blood will also be collected from each patient to produce 3ml PRP by cenrifugation. Cultured BMSCs will be collected and suspended by 3ml autologous PRP.
Active Comparator: PRP group
Three intra-articular injections in total and 3 ml autologous platelet rich plasma (PRP) for each injection. Time-points for intervention: 1) initial injection; 2) 3 months following initial injection; 3) 6 months following initial injection.
Biological: Auotologous PRP
30 mL of blood will also be collected from each patient to produce 3ml PRP by cenrifugation.
- Physical function change [ Time Frame: From before randomization until 3, 6, and 12 months after treatment start. ]Evaluation the physical function change Measured by WOMAC osteoarthritis index.
- Change in pain density [ Time Frame: From before randomization until 3, 6, and 12 months after treatment start. ]Evaluation the changing of pain density measured by Visual Analogue Scale. Draw a 10 cm horizontal line on the paper. One end of the line is 0, indicating no pain; the other end is 10, indicating severe pain; and the middle part indicates varying degrees of pain. The patient selects a point from the horizontal line and the length from 0 to this point is the Visual Analogue Scale score.
- Cartilage repair [ Time Frame: From before randomization until 3, 6, and 12 months after treatment start. ]Evaluation of cartilage repair under MRI. Recht criterion was used for grading articular cartilage injury of knee joint, including 0-IV grade, in which: 0 grade, normal articular cartilage, no obvious abnormal signal was found; 1 grade, the layered structure of cartilage disappeared, and there were focal low signal areas, but the surface was smooth; 2 grade, the surface of cartilage was irregular, the depth of cartilage injury was less than 50% cartilage thickness; 3 grade, the surface of cartilage was heavy. The degree of injury is irregular, the depth of injury is more than 50% of the thickness of cartilage or through the whole layer, but the surface of cartilage is not completely exfoliated; Grade IV, full-thickness cartilage defect, articular cartilage injury deep to the cortex, subchondral bone exposed.
- Change in MOS item short from health survey(SF-36) [ Time Frame: From before randomization until 3, 6, and 12 months after treatment start. ]Evaluation of the health-related quality of life change Measured by MOS item short from health survey(SF-36) after each cell injection. SF-36 is a self-administered questionnaire comprising 36-items measuring eight dimensions of general HRQOL: physical functioning (10 items), role limitation due to physical health problems (4 items), bodily pain (2 items), general health perceptions (5 items), vitality (4 items), social functioning (2 items), role limitations due to emotional problems (3 items), and general mental health (5 items).These outcomes will be grouped as physical component summary and mental component summary. The norm data is 0-100, the health related quality of life is increases as the scores are increased. The average score is 50.
- Change in Lequesne Index [ Time Frame: From before randomization until 3, 6, and 12 months after treatment start. ]Evaluation of severity of knee symptoms Lequesne Index includes the measurement of pain (5 items), walking distance (2 items), and activities of daily living (4 items). Maximal score is 24 and higher scores represent worse function
- Change in knee society score (KSS) [ Time Frame: From before randomization until 3, 6, and 12 months after treatment start. ]The knee society score is divided into four parts: it consists of the ''Symptoms''(25 points), the ''Patient satisfaction''(40 points), the ''Patient expectation''(15 points) and the ''Functional activities''(100 points). Each part will be evaluated separately.Higher scores indicate better knee score/satisfaction/functioning or higher expectations.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03969680
|Contact: Jian Chen, PhD||+0086 5356691999 ext email@example.com|
|Contact: Peiwen Lian, PhD||+0086 5356691999 ext firstname.lastname@example.org|
|Yantai Yuhuangding Hospital||Recruiting|
|Yantai, Shandong, China, 264000|
|Contact: Peiwen Lian, PhD +0086 5356691999 ext 82708 email@example.com|
|Study Director:||Jian Chen, PhD||Yantai Yuhuangding Hospital|