Knee OsteoarthritisNCT03969680
Mesenchymal Stem Cell Transplantation for Osteoarthritis
A study testing Auotologous BMSCs plus autologous PRP and Auotologous PRP in people with Knee Osteoarthritis, run by Yantai Yuhuangding Hospital at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 to 70 years
- Conditions the study is for
- Knee Osteoarthritis
- What is being tested?
- Auotologous BMSCs plus autologous PRP and Auotologous PRP
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2 participants
- Where
- 1 siteChina
- Study dates
- 8 Jul 2019to 28 Dec 2023
- 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 40 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.-
Who cannot join
- 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.
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- 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.-
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Autologous Mesenchymal Stem Cell Transplantation for the Treatment of Knee Osteoarthritis
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.
Read the detailed description
This is a single centered, randomized, single blind phase II clinical study. Patients will be divided into two groups of case and control. Patients of case group will receive intra-articular injection of autologous BMSCs suspended in 3 ml autologous PRP for 3 times, patients of control group will receive intra-articular injection of 3 ml of autologous PRP for 3 times. The investigators designed this clinical study to evaluate therapeutic effects of BM-MSCs in patients with severe knee osteoarthritis.
- Conditions
- Knee Osteoarthritis
- Being tested
- Auotologous BMSCs plus autologous PRP, Auotologous PRP
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Auotologous BMSCs plus autologous PRPBiological
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 PRPBiological
30 mL of blood will be collected from each patient to produce 3ml PRP by cenrifugation.
| Study group | Role | What they receive |
|---|---|---|
| BMSCs plus PRP group | Experimental | 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. Receives: Biological: Auotologous BMSCs plus autologous PRP |
| PRP group | Active comparator | 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. Receives: Biological: Auotologous PRP |
What is being measured
The primary outcome is the main question the study is designed to answer.
Physical function change
Evaluation the physical function change Measured by WOMAC osteoarthritis index.
Measured: 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.
Measured: From before randomization until 3, 6, and 12 months after treatment start.
Secondary outcomes (4)
Cartilage repair
Evaluation of cartilage repair under MRI. 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: From before randomization until 3, 6, and 12 months after treatment start.
Change in MOS item short from health survey(SF-36)
Evaluation of the health-related quality of life change Measured by MOS item short from health survey(SF-36) after each cell injection. SF-36 is a self-administered questionnaire comprising 36-items measuring eight dimensions of general HRQOL: physical functioning (10 items), role limitation due to physical health problems (4 items), bodily pain (2 items), general health perceptions (5 items), vitality (4 items), social functioning (2 items), role limitations due to emotional problems (3 items), and general mental health (5 items).These outcomes will be grouped as physical component summary and mental component summary. The norm data is 0-100, the health related quality of life is increases as the scores are increased. The average score is 50.
Measured: From before randomization until 3, 6, and 12 months after treatment start.
Change in Lequesne Index
Evaluation of severity of knee symptoms Lequesne Index includes the measurement of pain (5 items), walking distance (2 items), and activities of daily living (4 items). Maximal score is 24 and higher scores represent worse function
Measured: From before randomization until 3, 6, and 12 months after treatment start.
Change in knee society score (KSS)
The knee society score is divided into four parts: it consists of the ''Symptoms''(25 points), the ''Patient satisfaction''(40 points), the ''Patient expectation''(15 points) and the ''Functional activities''(100 points). Each part will be evaluated separately.Higher scores indicate better knee score/satisfaction/functioning or higher expectations.
Measured: From before randomization until 3, 6, and 12 months after treatment start.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 May 2019
- Study start8 Jul 2019
- Primary completion30 Oct 2023
- Study completion28 Dec 2023
Why it stopped: Due to government regulation
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Knee OsteoarthritisStudies of the same condition, open and under way.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 2 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yantai Yuhuangding Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Peiwen Lian, Yantai Yuhuangding Hospital
- Investigators
- Peiwen Lian, PhD, Study director, Yantai Yuhuangding Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03969680
- Sponsor's protocol ID
- 2019-002
- Status last verified
- Jan 2024
- First submitted
- 29 May 2019
- Last updated
- 24 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Autologous Mesenchymal Stem Cell Transplantation for the Treatment of Knee Osteoarthritis
- ClinicalTrials.gov ID
- NCT03969680
- Acronym / sponsor ID
- 2019-002
- Conditions
- Knee Osteoarthritis
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Due to government regulation
- Enrolment
- 2 participants (actual)
- Lead sponsor
- Yantai Yuhuangding HospitalUniversity, hospital or other
- Study start
- 8 Jul 2019 (actual)
- Primary completion
- 30 Oct 2023 (actual)
- Study completion
- 28 Dec 2023 (actual)
- First posted
- 31 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 bone marrow-derived mesenchymal stem cells (BMSCs) plus autologous platelet rich plasma (PRP) in the treatment of severe knee osteoarthritis.
Detailed description
This is a single centered, randomized, single blind phase II clinical study. Patients will be divided into two groups of case and control. Patients of case group will receive intra-articular injection of autologous BMSCs suspended in 3 ml autologous PRP for 3 times, patients of control group will receive intra-articular injection of 3 ml of autologous PRP for 3 times. The investigators designed this clinical study to evaluate therapeutic effects of BM-MSCs in patients with severe knee osteoarthritis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| BMSCs plus PRP group | Experimental | Biological: Auotologous BMSCs plus autologous PRPThree 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 comparator | Biological: Auotologous PRPThree 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. |
Who may qualify
- Ages
- 40 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.-
Key exclusion criteria (11 listed)
- 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.
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 |
|---|---|---|
| Auotologous BMSCs plus autologous PRP30 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. | Biological | BMSCs plus PRP group |
| Auotologous PRP30 mL of blood will be collected from each patient to produce 3ml PRP by cenrifugation. | Biological | PRP group |
Primary outcome
Physical function change
Time frame: From before randomization until 3, 6, and 12 months after treatment start.
Evaluation the physical function change Measured by WOMAC osteoarthritis index.
Change in pain density
Time frame: From before randomization until 3, 6, and 12 months after treatment start.
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.
4 secondary outcomes
Cartilage repair
Time frame: From before randomization until 3, 6, and 12 months after treatment start.
Change in MOS item short from health survey(SF-36)
Time frame: From before randomization until 3, 6, and 12 months after treatment start.
Change in Lequesne Index
Time frame: From before randomization until 3, 6, and 12 months after treatment start.
Change in knee society score (KSS)
Time frame: From before randomization until 3, 6, and 12 months after treatment start.
Results and safety
The study was stopped early (reason given: Due to government regulation). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jan 2024.
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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.
Peiwen Lian, PhD study director
Yantai Yuhuangding Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Auotologous BMSCs plus autologous PRP and Auotologous PRP in people with Knee Osteoarthritis, run by Yantai Yuhuangding Hospital 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 4 inclusion and 11 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: stopped early, as of the sponsor's last update on 24 Jan 2024. 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?
The study was stopped early (reason given: Due to government regulation). 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?
Physical function change (time frame: From before randomization until 3, 6, and 12 months after treatment start.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 24 Jan 2024.