Study Stopped
Due to government regulation
Mesenchymal Stem Cell Transplantation for Osteoarthritis
Autologous Mesenchymal Stem Cell Transplantation for the Treatment of Knee Osteoarthritis
1 other identifier
interventional
2
1 country
1
Brief Summary
The purpose of this study is to explore the efficacy and safety of autologous bone marrow-derived mesenchymal stem cells (BMSCs) plus autologous platelet rich plasma (PRP) in the treatment of severe knee osteoarthritis.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable knee-osteoarthritis
Started Jul 2019
Longer than P75 for not_applicable knee-osteoarthritis
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 29, 2019
CompletedFirst Posted
Study publicly available on registry
May 31, 2019
CompletedStudy Start
First participant enrolled
July 8, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 30, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
December 28, 2023
CompletedJanuary 24, 2024
January 1, 2024
4.3 years
May 29, 2019
January 22, 2024
Conditions
Outcome Measures
Primary Outcomes (2)
Physical function change
Evaluation the physical function change Measured by WOMAC osteoarthritis index.
From before randomization until 3, 6, and 12 months after treatment start.
Change in pain density
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.
From before randomization until 3, 6, and 12 months after treatment start.
Secondary Outcomes (4)
Cartilage repair
From before randomization until 3, 6, and 12 months after treatment start.
Change in MOS item short from health survey(SF-36)
From before randomization until 3, 6, and 12 months after treatment start.
Change in Lequesne Index
From before randomization until 3, 6, and 12 months after treatment start.
Change in knee society score (KSS)
From before randomization until 3, 6, and 12 months after treatment start.
Study Arms (2)
BMSCs plus PRP group
EXPERIMENTALThree 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.
PRP group
ACTIVE COMPARATORThree 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.
Interventions
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 be collected from each patient to produce 3ml PRP by cenrifugation. Cultured BMSCs will be collected and suspended by 3ml autologous PRP.
30 mL of blood will be collected from each patient to produce 3ml PRP by cenrifugation.
Eligibility Criteria
You may qualify if:
- Subject has Kellgren and Lawrence grade II-IV primary osteoarthritis as determined by X-ray.
- Subject's pain score is 8-13 points (Lequesne's index).
- Ages between 40-70 years.
- Signed informed consent from the subject.-
You may not qualify if:
- Subject infected with hepatitis B, hepatitis C, HIV, syphilis or HTLV
- Subject not suitable for bone marrow suction surgery.
- Subject with hypersensitivity/allergy to anesthetic.
- Subject's creatinine values higher than 1.6mg/dl.
- Subject with body mass index, BMI over 30.
- Subject's studied knee treated with intra-articular injection therapy within 6 months prior to screen.
- Subject has undergone surgery on studied knee, including fracture surgery, arthroscopic surgery, meniscus repair surgery, or cruciate ligament reconstruction surgery.
- Subject enrolled in any other cell therapy studies within the past 30 days.
- Subject who the investigator considers inappropriate for the clinical trial due to any other reasons than those listed above.
- Subject has a history of gouty arthritis, septic arthritis, rheumatoid arthritis and any other autoimmune arthritis of the knee joint.
- Subject has had major medical problems in vital organs, such as; heart, liver, kidney, or lung.-
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Yantai Yuhuangding Hospital
Yantai, Shandong, 264000, China
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Peiwen Lian, PhD
Yantai Yuhuangding Hospital
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principle Investigator
Study Record Dates
First Submitted
May 29, 2019
First Posted
May 31, 2019
Study Start
July 8, 2019
Primary Completion
October 30, 2023
Study Completion
December 28, 2023
Last Updated
January 24, 2024
Record last verified: 2024-01