Clinical trial NCT03956719: Treatment of Early Knee Osteoarthritis With Autologous Adipose-derived Mesenchymal Stem Cells
Official title: Efficacy and Safety of Autologous Adipose-derived Mesenchymal Stem Cells in the Treatment of Early Knee Osteoarthritis
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Knee Osteoarthritis
Keywords: Autologous adipose-derived mesenchymal stem cells
Knee Osteoarthritis
Lead sponsor: Qilu Hospital of Shandong University
Sponsor class: OTHER
First posted: 2019-05-21
Enrollment: 8
Sex: ALL
Minimum age (years): 15
Maximum age (years): 65
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to explore the efficacy and safety of autologous adipose mesenchymal stem cells in the treatment of early knee arthritis. Investigator believes that autologous adipose mesenchymal stem cells can relieve pain, improve knee function, promote knee cartilage regeneration and improve life satisfaction of patients.

Detailed description: Investigators extracted abdominal fat from eight patients, extracted autologous adipose mesenchymal stem cells and injected them into the knee joint of the patients. The data were followed up regularly after operation and compared with those before operation.

Eligibility criteria: Inclusion Criteria:

* Aged 18-65 years, male and female, patient can tolerate surgery;
* Clinical diagnosis of early stage degenerative arthritis by Radiographic Criteria and physical examination;
* Obviously extra-articular malformation;
* Course of disease ≥ six months;
* No medication for knee osteoarthritis in the past three months
* Evaluated has not at the risk of cancer;
* Subjects who understand and sign the consent form for this study.

Exclusion Criteria:

* Acute joint injury;
* Patients with severe primary diseases, such as cardiovascular,cerebrovascular, liver, kidney and hematopoietic system, and psychosis;
* Cancer patients;
* Women who are pregnant or breast feeding,or allergic constitution patient;
* Positive serology for HIV-1 or HIV-2, Hepatitis B (HBsAg, Anti-Hepatitis C virus -Ab), Hepatitis C (Anti-hepatitis C virus -Ab) and syphilis;
* Receive other open surgery related to knee operation within 6 months;
* Participation in another clinical trial;
* Failing to comply with the inclusion criteria, unwilling to comply with the research approach, or incomplete data affecting the curative effect or safety judgment.

Primary outcomes:
measure: Hospital for special surgery knee score postoperative 1 month
timeFrame: postoperative 1 month
measure: Hospital for special surgery knee score postoperative 3 month
timeFrame: postoperative 3 month
measure: Hospital for special surgery knee score postoperative 6 month
timeFrame: postoperative 6 month
measure: Visual Analogue Scale Postoperative 1 month
timeFrame: Postoperative 1 month
measure: Visual Analogue Scale Postoperative 3 month
timeFrame: Postoperative 3 month
measure: Visual Analogue Scale Postoperative 6 month
timeFrame: Postoperative 6 month
measure: Evaluation of cartilage repair under MRI postoperative 3 month
timeFrame: postoperative 3 month
measure: Evaluation of cartilage repair under MRI postoperative 6 month
timeFrame: postoperative 6 month
measure: Degree of meniscus injury under MRI postoperative 3 month
timeFrame: postoperative 3 month
measure: Degree of meniscus injury under MRI postoperative 6 month
timeFrame: postoperative 6 month
measure: Squatting to Standing Time postoperative 1 month
timeFrame: postoperative 1 month
measure: Squatting to Standing Time postoperative 3 month
timeFrame: postoperative 3 month
measure: Squatting to Standing Time postoperative 6 month
timeFrame: postoperative 6 month
Secondary outcomes:
measure: Satisfaction of patients postoperative 1 month
timeFrame: postoperative 1 month
measure: Satisfaction of patients postoperative 3 month
timeFrame: postoperative 3 month
measure: Satisfaction of patients postoperative 6 month
timeFrame: postoperative 6 month
Other outcomes:
Locations:
city: Jinan
country: China
facility: Qilu hospital of Shandong University
state: Shandong
Study officials:
affiliation: Qilu Hospital of Shandong University
name: Peilai Liu, MD
role: STUDY_CHAIR
References:
citation: Yu D, Xu J, Liu F, Wang X, Mao Y, Zhu Z. Subchondral bone changes and the impacts on joint pain and articular cartilage degeneration in osteoarthritis. Clin Exp Rheumatol. 2016 Sep-Oct;34(5):929-934. Epub 2016 Aug 31.
citation: Wilusz RE, Sanchez-Adams J, Guilak F. The structure and function of the pericellular matrix of articular cartilage. Matrix Biol. 2014 Oct;39:25-32. doi: 10.1016/j.matbio.2014.08.009. Epub 2014 Aug 27.
citation: Fodor PB, Paulseth SG. Adipose Derived Stromal Cell (ADSC) Injections for Pain Management of Osteoarthritis in the Human Knee Joint. Aesthet Surg J. 2016 Feb;36(2):229-36. doi: 10.1093/asj/sjv135. Epub 2015 Aug 3.
citation: Awad ME, Hussein KA, Helwa I, Abdelsamid MF, Aguilar-Perez A, Mohsen I, Hunter M, Hamrick MW, Isales CM, Elsalanty M, Hill WD, Fulzele S. Meta-Analysis and Evidence Base for the Efficacy of Autologous Bone Marrow Mesenchymal Stem Cells in Knee Cartilage Repair: Methodological Guidelines and Quality Assessment. Stem Cells Int. 2019 Apr 7;2019:3826054. doi: 10.1155/2019/3826054. eCollection 2019.
citation: Senn-Malashonak A, Wallek S, Schmidt K, Rosenhagen A, Vogt L, Bader P, Banzer W. Psychophysical effects of an exercise therapy during pediatric stem cell transplantation: a randomized controlled trial. Bone Marrow Transplant. 2019 Nov;54(11):1827-1835. doi: 10.1038/s41409-019-0535-z. Epub 2019 May 14.
citation: Browne JA, Nho SJ, Goodman SB, Callaghan JJ, Della Valle CJ. Stem Cells and Platelet-Rich Plasma Injections for Advanced Hip and Knee Arthritis: Enthusiasm Outpaces Science. J Arthroplasty. 2019 Jun;34(6):1049-1050. doi: 10.1016/j.arth.2019.03.074. Epub 2019 Apr 3. No abstract available.
citation: Strotman PK, Novicoff WM, Nelson SJ, Browne JA. Increasing Public Interest in Stem Cell Injections for Osteoarthritis of the Hip and Knee: A Google Trends Analysis. J Arthroplasty. 2019 Jun;34(6):1053-1057. doi: 10.1016/j.arth.2019.03.002. Epub 2019 Mar 8.
citation: Chareancholvanich K, Pornrattanamaneewong C, Narkbunnam R. Increased cartilage volume after injection of hyaluronic acid in osteoarthritis knee patients who underwent high tibial osteotomy. Knee Surg Sports Traumatol Arthrosc. 2014 Jun;22(6):1415-23. doi: 10.1007/s00167-013-2735-1. Epub 2013 Oct 27.