Clinical trial NCT03955497: Effectiveness of Autologous Adipose-derived Stem Cells in the Treatment of Knee Cartilage Injury
Official title: Efficacy and Safety Research of Autologous Adipose-derived Mesenchymal Stem Cell Gel in the Treatment of Cartilage Damage in the Knee
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
PHASE2
Conditions: Knee Osteoarthritis
Cartilage Degeneration
Keywords: Knee Osteoarthritis
Stem Cell
Cartilage repair
Lead sponsor: Qilu Hospital of Shandong University
Sponsor class: OTHER
First posted: 2019-05-20
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study was aimed to evaluate the efficacy and safety of Autologous Adipose-derived Mesenchymal Stem Cell Gel combine with High tibial osteotomy therapy in the treatment of cartilage damage in the knee. Investigator believe that this method will enable patients to recover better knee function and more repair of knee cartilage.

Detailed description: The patients who will underwent high tibial osteotomy were randomly divided into the experimental group and the control group. Abdominal fat extraction before operation in experimental group to prepare Adipose-derived Mesenchymal Stem Cell Gel, while the control group only underwent high tibial osteotomy. One month after operation, the experimental group was injected with Adipose-derived Mesenchymal Stem Cell Gel into the joint cavity, and the control group was injected with sodium hyaluronate in the joint cavity. Two groups of patients were followed up.

Eligibility criteria: Inclusion Criteria:

* Aged 18-65 years, male and female, patient can tolerate surgery;
* Clinical diagnosis of degenerative arthritis by Radiographic Criteria;
* Obviously extra-articular malformation;
* Good contralateral interventricular cartilage;
* Course of disease ≥ six months;
* There was no obvious abnormality in tumor marker detection,or patient was 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: Hospital for special surgery knee score postoperative 12 month
timeFrame: postoperative 12 month
measure: Hospital for special surgery knee score postoperative 24 month
timeFrame: postoperative 24 month
measure: Hospital for special surgery knee score postoperative 36 month
timeFrame: postoperative 36 month
measure: Visual Analogue Scale Postoperative Day 1
timeFrame: Postoperative Day 1
measure: Visual Analogue Scale Postoperative Day 2
timeFrame: Postoperative Day 2
measure: Visual Analogue Scale Postoperative Day 3
timeFrame: Postoperative Day 3
measure: Visual Analogue Scale Postoperative Day 7
timeFrame: Postoperative Day 7
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: Visual Analogue Scale Postoperative 12 month
timeFrame: Postoperative 12 month
measure: Visual Analogue Scale Postoperative Day One
timeFrame: Postoperative Day One
measure: Visual Analogue Scale Postoperative 24 month
timeFrame: Postoperative 24month
measure: Visual Analogue Scale Postoperative 36 month
timeFrame: Postoperative 36 month
measure: Evaluation of cartilage repair under MRI postoperative 12 month
timeFrame: Postoperative 12 month
measure: Evaluation of cartilage repair under MRI postoperative 24 month
timeFrame: Postoperative 24 month
measure: Evaluation of cartilage repair under MRI postoperative 36 month
timeFrame: Postoperative 36 month
measure: Degree of meniscus injury under MRI postoperative 12 month
timeFrame: postoperative 12 month
measure: Degree of meniscus injury under MRI postoperative 24 month
timeFrame: postoperative 24 month
measure: Degree of meniscus injury under MRI postoperative 36 month
timeFrame: postoperative 36 month
measure: Evaluation of cartilage repair under arthroscope postoperative 12 month
timeFrame: postoperative 12 month
measure: Degree of meniscus injury under arthroscope postoperative 12 month
timeFrame: postoperative 12 month
Secondary outcomes:
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
measure: Squatting to Standing Time postoperative 12 month
timeFrame: postoperative 12 month
measure: Squatting to Standing Time postoperative 24 month
timeFrame: postoperative 24 month
measure: Squatting to Standing Time postoperative 36 month
timeFrame: postoperative 36 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: Baer PC, Geiger H. Adipose-derived mesenchymal stromal/stem cells: tissue localization, characterization, and heterogeneity. Stem Cells Int. 2012;2012:812693. doi: 10.1155/2012/812693. Epub 2012 Apr 12.
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.