Knee OsteoarthritisNCT03956719
Treatment of Early Knee Osteoarthritis With Autologous Adipose-derived Mesenchymal Stem Cells
A study testing Autologous adipose-derived mesenchymal stem cells and abdominal liposuction in people with Knee Osteoarthritis, run by Qilu Hospital of Shandong University at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 15 to 65 years
- Conditions the study is for
- Knee Osteoarthritis
- What is being tested?
- Autologous adipose-derived mesenchymal stem cells and abdominal liposuction
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 1 siteChina
- Study dates
- 2 Mar 2019to 1 Nov 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 15 to 65 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy and Safety of Autologous Adipose-derived Mesenchymal Stem Cells in the Treatment of Early Knee Osteoarthritis
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.
Read the 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.
- Conditions
- Knee Osteoarthritis
- Being tested
- Autologous adipose-derived mesenchymal stem cells, abdominal liposuction
- Keywords
- Autologous adipose-derived mesenchymal stem cells, Knee Osteoarthritis
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Autologous adipose-derived mesenchymal stem cellsDrug
Autologous adipose-derived mesenchymal stem cells is extracted from human abdominal fat, which is crushed, filtered and immediately returned to the articular cavity through a specific device.
abdominal liposuctionProcedure or surgery
50 ml abdominal fat was extracted by abdominal liposuction to prepare autologous adipose-derived mesenchymal stem cells
| Study group | Role | What they receive |
|---|---|---|
| Autologous adipose-derived mesenchymal stem cells | Experimental | Patients receiving intra-articular injection of autologous adipose-derived mesenchymal stem cells Receives: Drug: Autologous adipose-derived mesenchymal stem cells; Procedure: abdominal liposuction |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hospital for special surgery knee score postoperative 1 month
Hospital for special surgery knee score is a knee function scoring system with a full score of 100. 0 means the loss of knee function, 100 means the best knee function, and the greater the value, the better knee function.
Measured: postoperative 1 month
Hospital for special surgery knee score postoperative 3 month
Hospital for special surgery knee score is a knee function scoring system with a full score of 100. 0 means the loss of knee function, 100 means the best knee function, and the greater the value, the better knee function.
Measured: postoperative 3 month
Hospital for special surgery knee score postoperative 6 month
Hospital for special surgery knee score is a knee function scoring system with a full score of 100. 0 means the loss of knee function, 100 means the best knee function, and the greater the value, the better knee function.
Measured: postoperative 6 month
Visual Analogue Scale Postoperative 1 month
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.
Measured: Postoperative 1 month
Visual Analogue Scale Postoperative 3 month
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.
Measured: Postoperative 3 month
Visual Analogue Scale Postoperative 6 month
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.
Measured: Postoperative 6 month
Evaluation of cartilage repair under MRI postoperative 3 month
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.
Measured: postoperative 3 month
Evaluation of cartilage repair under MRI postoperative 6 month
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.
Measured: postoperative 6 month
Degree of meniscus injury under MRI postoperative 3 month
Stoller's criteria were used in the classification of meniscal injuries, including 0-3 grades, in which: 0 grade, the shape of meniscus was regular, complete and even low signal; 1 grade, focal ellipse or circular high signal appeared in the meniscus, which did not extend to the articular surface and margin of the meniscus; 2 grade, the meniscus showed horizontal linear high signal extending to the articular margin of the meniscus.
But it did not exceed the articular surface; in grade III, the shape of meniscus was irregular and incomplete. Irregular or linear high signal appeared in the meniscus and extended to the articular surface of meniscus. The grade I and II symptoms of meniscus injury were mild, suggesting meniscus degeneration, and grade III suggesting meniscus tear.
Measured: postoperative 3 month
Degree of meniscus injury under MRI postoperative 6 month
Stoller's criteria were used in the classification of meniscal injuries, including 0-3 grades, in which: 0 grade, the shape of meniscus was regular, complete and even low signal; 1 grade, focal ellipse or circular high signal appeared in the meniscus, which did not extend to the articular surface and margin of the meniscus; 2 grade, the meniscus showed horizontal linear high signal extending to the articular margin of the meniscus.
But it did not exceed the articular surface; in grade III, the shape of meniscus was irregular and incomplete. Irregular or linear high signal appeared in the meniscus and extended to the articular surface of meniscus. The grade I and II symptoms of meniscus injury were mild, suggesting meniscus degeneration, and grade III suggesting meniscus tear.
Measured: postoperative 6 month
Squatting to Standing Time postoperative 1 month
The patient squatted on the floor and then stood up completely for five consecutive times, recording the time required.
Measured: postoperative 1 month
Squatting to Standing Time postoperative 3 month
The patient squatted on the floor and then stood up completely for five consecutive times, recording the time required.
Measured: postoperative 3 month
Squatting to Standing Time postoperative 6 month
The patient squatted on the floor and then stood up completely for five consecutive times, recording the time required.
Measured: postoperative 6 month
Secondary outcomes (3)
Satisfaction of patients postoperative 1 month
The satisfaction degree of patients with treatment effect, full score of 10 points, 1 represents not satisfied at all, 10 represents very satisfied.
Measured: postoperative 1 month
Satisfaction of patients postoperative 3 month
The satisfaction degree of patients with treatment effect, full score of 10 points, 1 represents not satisfied at all, 10 represents very satisfied.
Measured: postoperative 3 month
Satisfaction of patients postoperative 6 month
The satisfaction degree of patients with treatment effect, full score of 10 points, 1 represents not satisfied at all, 10 represents very satisfied.
Measured: postoperative 6 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 May 2019
- Study start2 Mar 2019
- Primary completion9 Sep 2020
- Study completion1 Nov 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Knee OsteoarthritisStudies of the same condition, open and under way.
- More trials run by Qilu Hospital of Shandong UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 8 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Qilu Hospital of Shandong University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Peilai Liu, MD, Study chair, Qilu Hospital of Shandong University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03956719
- Sponsor's protocol ID
- 2019042
- Status last verified
- Sep 2020
- First submitted
- 16 May 2019
- Last updated
- 16 Sep 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The acquisition of individual participant data needs the consent of Peilai Liu, the person in charge.
Publications
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.
PubMed 27606839Wilusz 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.
PubMed 25172825Fodor 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.
PubMed 26238455Awad 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.
PubMed 31089328Senn-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.
PubMed 31089282Browne 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.
PubMed 31000403Strotman 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.
PubMed 30935801Chareancholvanich 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.
PubMed 24162762
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Autologous Adipose-derived Mesenchymal Stem Cells in the Treatment of Early Knee Osteoarthritis
- ClinicalTrials.gov ID
- NCT03956719
- Acronym / sponsor ID
- 2019042
- Conditions
- Knee Osteoarthritis
- Keywords
- Autologous adipose-derived mesenchymal stem cells, Knee Osteoarthritis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 8 participants (estimated)
- Lead sponsor
- Qilu Hospital of Shandong UniversityUniversity, hospital or other
- Study start
- 2 Mar 2019 (actual)
- Primary completion
- 9 Sep 2020 (actual)
- Study completion
- 1 Nov 2020 (estimated)
- First posted
- 21 May 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Autologous adipose-derived mesenchymal stem cells | Experimental | Drug: Autologous adipose-derived mesenchymal stem cells, Procedure: abdominal liposuctionPatients receiving intra-articular injection of autologous adipose-derived mesenchymal stem cells |
Who may qualify
- Ages
- 15 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (8 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Autologous adipose-derived mesenchymal stem cellsAutologous adipose-derived mesenchymal stem cells is extracted from human abdominal fat, which is crushed, filtered and immediately returned to the articular cavity through a specific device. | Drug | Autologous adipose-derived mesenchymal stem cells |
| abdominal liposuction50 ml abdominal fat was extracted by abdominal liposuction to prepare autologous adipose-derived mesenchymal stem cells | Procedure or surgery | Autologous adipose-derived mesenchymal stem cells |
Primary outcome
Hospital for special surgery knee score postoperative 1 month
Time frame: postoperative 1 month
Hospital for special surgery knee score is a knee function scoring system with a full score of 100. 0 means the loss of knee function, 100 means the best knee function, and the greater the value, the better knee function.
Hospital for special surgery knee score postoperative 3 month
Time frame: postoperative 3 month
Hospital for special surgery knee score is a knee function scoring system with a full score of 100. 0 means the loss of knee function, 100 means the best knee function, and the greater the value, the better knee function.
Hospital for special surgery knee score postoperative 6 month
Time frame: postoperative 6 month
Hospital for special surgery knee score is a knee function scoring system with a full score of 100. 0 means the loss of knee function, 100 means the best knee function, and the greater the value, the better knee function.
Visual Analogue Scale Postoperative 1 month
Time frame: Postoperative 1 month
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.
Visual Analogue Scale Postoperative 3 month
Time frame: Postoperative 3 month
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.
Visual Analogue Scale Postoperative 6 month
Time frame: Postoperative 6 month
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.
Evaluation of cartilage repair under MRI postoperative 3 month
Time frame: postoperative 3 month
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.
Evaluation of cartilage repair under MRI postoperative 6 month
Time frame: postoperative 6 month
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.
Degree of meniscus injury under MRI postoperative 3 month
Time frame: postoperative 3 month
Stoller's criteria were used in the classification of meniscal injuries, including 0-3 grades, in which: 0 grade, the shape of meniscus was regular, complete and even low signal; 1 grade, focal ellipse or circular high signal appeared in the meniscus, which did not extend to the articular surface and margin of the meniscus; 2 grade, the meniscus showed horizontal linear high signal extending to the articular margin of the meniscus. But it did not exceed the articular surface; in grade III, the shape of meniscus was irregular and incomplete. Irregular or linear high signal appeared in the meniscus and extended to the articular surface of meniscus. The grade I and II symptoms of meniscus injury were mild, suggesting meniscus degeneration, and grade III suggesting meniscus tear.
Degree of meniscus injury under MRI postoperative 6 month
Time frame: postoperative 6 month
Stoller's criteria were used in the classification of meniscal injuries, including 0-3 grades, in which: 0 grade, the shape of meniscus was regular, complete and even low signal; 1 grade, focal ellipse or circular high signal appeared in the meniscus, which did not extend to the articular surface and margin of the meniscus; 2 grade, the meniscus showed horizontal linear high signal extending to the articular margin of the meniscus. But it did not exceed the articular surface; in grade III, the shape of meniscus was irregular and incomplete. Irregular or linear high signal appeared in the meniscus and extended to the articular surface of meniscus. The grade I and II symptoms of meniscus injury were mild, suggesting meniscus degeneration, and grade III suggesting meniscus tear.
Squatting to Standing Time postoperative 1 month
Time frame: postoperative 1 month
The patient squatted on the floor and then stood up completely for five consecutive times, recording the time required.
Squatting to Standing Time postoperative 3 month
Time frame: postoperative 3 month
The patient squatted on the floor and then stood up completely for five consecutive times, recording the time required.
Squatting to Standing Time postoperative 6 month
Time frame: postoperative 6 month
The patient squatted on the floor and then stood up completely for five consecutive times, recording the time required.
3 secondary outcomes
Satisfaction of patients postoperative 1 month
Time frame: postoperative 1 month
Satisfaction of patients postoperative 3 month
Time frame: postoperative 3 month
Satisfaction of patients postoperative 6 month
Time frame: postoperative 6 month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Sep 2020.
- Background: PubMed 27606839Yu 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.
- Background: PubMed 25172825Wilusz 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.
- Background: PubMed 26238455Fodor 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.
- Background: PubMed 31089328Awad 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.
- Background: PubMed 31089282Senn-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.
- Background: PubMed 31000403Browne 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.
- Background: PubMed 30935801Strotman 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.
- Background: PubMed 24162762Chareancholvanich 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.
- Individual participant dataSharing planned: No. The acquisition of individual participant data needs the consent of Peilai Liu, the person in charge.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Peilai Liu, MD study chair
Qilu Hospital of Shandong University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Autologous adipose-derived mesenchymal stem cells and abdominal liposuction in people with Knee Osteoarthritis, run by Qilu Hospital of Shandong University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 16 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hospital for special surgery knee score postoperative 1 month (time frame: postoperative 1 month). The study lists 13 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03956719, which also lists 8 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Sep 2020.