Mesenchymal Stem Cell Transplantation for Osteoarthritis
NCT ID: NCT03969680
Last Updated: 2024-01-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
NA
2 participants
INTERVENTIONAL
2019-07-08
2023-12-28
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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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.
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 be collected from each patient to produce 3ml PRP by cenrifugation. Cultured BMSCs will be collected and suspended by 3ml autologous PRP.
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.
Auotologous PRP
30 mL of blood will be collected from each patient to produce 3ml PRP by cenrifugation.
Interventions
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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 be collected from each patient to produce 3ml PRP by cenrifugation. Cultured BMSCs will be collected and suspended by 3ml autologous PRP.
Auotologous PRP
30 mL of blood will be collected from each patient to produce 3ml PRP by cenrifugation.
Eligibility Criteria
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Inclusion Criteria
2. Subject's pain score is 8-13 points (Lequesne's index).
3. Ages between 40-70 years.
4. Signed informed consent from the subject.-
Exclusion Criteria
2. Subject not suitable for bone marrow suction surgery.
3. Subject with hypersensitivity/allergy to anesthetic.
4. Subject's creatinine values higher than 1.6mg/dl.
5. Subject with body mass index, BMI over 30.
6. Subject's studied knee treated with intra-articular injection therapy within 6 months prior to screen.
7. Subject has undergone surgery on studied knee, including fracture surgery, arthroscopic surgery, meniscus repair surgery, or cruciate ligament reconstruction surgery.
8. Subject enrolled in any other cell therapy studies within the past 30 days.
9. Subject who the investigator considers inappropriate for the clinical trial due to any other reasons than those listed above.
10. Subject has a history of gouty arthritis, septic arthritis, rheumatoid arthritis and any other autoimmune arthritis of the knee joint.
11. Subject has had major medical problems in vital organs, such as; heart, liver, kidney, or lung.-
40 Years
70 Years
ALL
No
Sponsors
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Yantai Yuhuangding Hospital
OTHER
Responsible Party
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Peiwen Lian
Principle Investigator
Principal Investigators
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Peiwen Lian, PhD
Role: STUDY_DIRECTOR
Yantai Yuhuangding Hospital
Locations
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Yantai Yuhuangding Hospital
Yantai, Shandong, China
Countries
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Other Identifiers
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2019-002
Identifier Type: -
Identifier Source: org_study_id
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