Knee OsteoarthritisPhase 1/2NCT02142842
Autologous Adipose Stem Cells and Platelet Rich Plasma Therapy for Patients With Knee Osteoarthritis
A Phase 1/2 study testing Autologous adipose tissue stromal vascular fraction and platelet rich plasma in people with Knee Osteoarthritis, run by University of Science Ho Chi Minh City at 3 sites in Vietnam.
Trial summary
Adipose stem cells and platelet rich plasma can regenerate the injured cartilage. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Knee Osteoarthritis
- What is being tested?
- Autologous adipose tissue stromal vascular fraction and platelet rich plasma
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 3 sitesVietnam
- Study dates
- Apr 2013to Dec 2015
- Phase
- Phase 1/2
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age >18 years and ability to understand the planned treatment.
- Idiopathic or secondary osteoarthritis of the knee with grade 2, 3 radiographic severity
- Ability and willingness to undergo liposuction
Who cannot join
- Pregnant women or cognitively impaired adults.
- Presence of large meniscal tears ("bucket handle" tears), as detected by clinical examination or by magnetic resonance imaging.
- Inflammatory or postinfectious arthritis.
- More than 5 degrees of varus or valgus deformity.
- Kellgren Lawrence grade 4 osteoarthritis in two compartments (the medial or lateral compartments of the tibiofemoral joint or the patellofemoral compartment) in persons over 60 years of age.
- Intraarticular corticosteroid injection within the previous 3 months.
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- A major neurologic deficit.
- Serious medical illness with a life expectancy of less than 1 year.
- Prior admission for substance abuse
- Body Mass Index (BMI) of 40 kg/m2 or greater
- Patient receiving experimental medication or participating in another clinical study within 30 days of signing the informed consent
- In the opinion of the investigator or the sponsor the patient is unsuitable for cellular therapy
Trial locations and contacts
3 sites in 1 country.
Vietnam3 sites
115 Hospital, Ho Chi Minh city
Ho Chi Minh City
Laboratory of Stem Cell Research and Application, University of Science, Vietnam National University, Ho Chi Minh
Ho Chi Minh City
Van Hanh Hospital, Ho Chi Minh city, VN
Ho Chi Minh City
About this study
Official title: Phase I/II Study of Transplantation of Autologous Adipose Stem Cells and Activated Platelet Rich Plasma in Knee Osteoarthritis Treatment
Adipose stem cells and platelet rich plasma can regenerate the injured cartilage.
Read the detailed description
The proposed study is two centers, unblinded, non randomized, phase I/II trial in which the patients will be treated with a single dose of autologous stromal vascular cells (SVF) in combination with platelet rich plasma (PRP).
This study aimes to evaluate the clinical efficiency of autologous adipose tissue-derived MSC transplantation in patients with confirmed osteoarthritis at grade II and III. Adipose tissue is isolated from the belly, and used for extraction of the SVF. The SVF is mixed with activated platelet-rich plasma before injection. The clinical efficiencies are evaluated by the pain score (VAS), Lysholm score, and MRI findings. SVF is isolated from about 100 mL of adipose tissue, and PRP is prepared from 20 mL of peripheral blood. Total injection volume will be about 5-10 mL. The total number of SVF to be injected is 1.0 x 10(7) to 5 x 10(7).
- Conditions
- Knee Osteoarthritis
- Being tested
- Autologous adipose tissue stromal vascular fraction and platelet rich plasma
- Keywords
- Adipose stem cell, Platelet rich plasma, Knee Osteoarthritis, Injured cartilage
- 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 tissue stromal vascular fraction and platelet rich plasmaBiological
| Study group | Role | What they receive |
|---|---|---|
| Treatment | Experimental | Autologous stromal vascular fraction (SVF) and platelet rich plasma (PRP) will be injected into joints of 16 patients with grade 2, 3 radiographic OA severity with 16 patients as control. Receives: Biological: Autologous adipose tissue stromal vascular fraction and platelet rich plasma |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with adverse events
Measured: 6 months
Secondary outcomes (3)
Change from the baseline pain score (VAS) at 6 months
Measured: 6 months, 12 months, 18 months
Change from baseline Lysholm score at 6 months
Measured: 6 months, 12 months, 18 months
Change from baseline MRI assessment
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 May 2014 (estimated)
- Study startApr 2013
- Primary completionDec 2015
- Study completionDec 2015
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 1/2
- Primary purpose
- Treatment
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Science Ho Chi Minh City
- Sponsor type
- University, hospital or other
- Collaborators
- GeneWorld Co., Ltd., Ho Chi Minh, Van Hanh General Hospital, 115 People's Hospital
- Responsible party
- Principal investigator, Phuc Van Pham, University of Science Ho Chi Minh City
- Investigators
- Phuc V Pham, PhD, Study director, Laboratory of Stem Cell Research and Application, University of Science, VNU-HCM, VNPhuong TB Le, MSc, MD, Principal investigator, Van Hanh Hospital, Ho Chi Minh city, VNPhu D Nguyen, PhD, MD, Principal investigator, 115 Hospital, HCMHo H La, MD, Principal investigator, Van Hanh Hospital, Ho Chi Minh city, VNTung DX Tran, MSc, MD, Principal investigator, Van Hanh Hospital, Ho Chi Minh city, VN
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02142842
- Sponsor's protocol ID
- 1438/QDBYT
- Status last verified
- Jan 2016
- First submitted
- 16 May 2014
- Last updated
- 22 Jan 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 22 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I/II Study of Transplantation of Autologous Adipose Stem Cells and Activated Platelet Rich Plasma in Knee Osteoarthritis Treatment
- ClinicalTrials.gov ID
- NCT02142842
- Acronym / sponsor ID
- 1438/QDBYT
- Conditions
- Knee Osteoarthritis
- Keywords
- Adipose stem cell, Platelet rich plasma, Knee Osteoarthritis, Injured cartilage
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- University of Science Ho Chi Minh CityUniversity, hospital or other
- Collaborators
- GeneWorld Co., Ltd., Ho Chi Minh, Van Hanh General Hospital, 115 People's Hospital
- Study start
- Apr 2013
- Primary completion
- Dec 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 20 May 2014 (estimated)
- 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.
Adipose stem cells and platelet rich plasma can regenerate the injured cartilage.
Detailed description
The proposed study is two centers, unblinded, non randomized, phase I/II trial in which the patients will be treated with a single dose of autologous stromal vascular cells (SVF) in combination with platelet rich plasma (PRP).
This study aimes to evaluate the clinical efficiency of autologous adipose tissue-derived MSC transplantation in patients with confirmed osteoarthritis at grade II and III. Adipose tissue is isolated from the belly, and used for extraction of the SVF. The SVF is mixed with activated platelet-rich plasma before injection. The clinical efficiencies are evaluated by the pain score (VAS), Lysholm score, and MRI findings. SVF is isolated from about 100 mL of adipose tissue, and PRP is prepared from 20 mL of peripheral blood. Total injection volume will be about 5-10 mL. The total number of SVF to be injected is 1.0 x 10(7) to 5 x 10(7).
Study design
- Primary purpose
- Treatment
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment | Experimental | Biological: Autologous adipose tissue stromal vascular fraction and platelet rich plasmaAutologous stromal vascular fraction (SVF) and platelet rich plasma (PRP) will be injected into joints of 16 patients with grade 2, 3 radiographic OA severity with 16 patients as control. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age >18 years and ability to understand the planned treatment.
- Idiopathic or secondary osteoarthritis of the knee with grade 2, 3 radiographic severity
- Ability and willingness to undergo liposuction
Key exclusion criteria (12 listed)
- Pregnant women or cognitively impaired adults.
- Presence of large meniscal tears ("bucket handle" tears), as detected by clinical examination or by magnetic resonance imaging.
- Inflammatory or postinfectious arthritis.
- More than 5 degrees of varus or valgus deformity.
- Kellgren Lawrence grade 4 osteoarthritis in two compartments (the medial or lateral compartments of the tibiofemoral joint or the patellofemoral compartment) in persons over 60 years of age.
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 tissue stromal vascular fraction and platelet rich plasma | Biological | Treatment |
Primary outcome
Number of participants with adverse events
Time frame: 6 months
3 secondary outcomes
Change from the baseline pain score (VAS) at 6 months
Time frame: 6 months, 12 months, 18 months
Change from baseline Lysholm score at 6 months
Time frame: 6 months, 12 months, 18 months
Change from baseline MRI assessment
Time frame: 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jan 2016.
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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.
Phuc V Pham, PhD study director
Laboratory of Stem Cell Research and Application, University of Science, VNU-HCM, VN
Phuong TB Le, MSc, MD principal investigator
Van Hanh Hospital, Ho Chi Minh city, VN
Phu D Nguyen, PhD, MD principal investigator
115 Hospital, HCM
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Autologous adipose tissue stromal vascular fraction and platelet rich plasma in people with Knee Osteoarthritis, run by University of Science Ho Chi Minh City at 3 sites in Vietnam.
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 3 inclusion and 12 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: finished, as of the sponsor's last update on 22 Jan 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Vietnam. 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.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Number of participants with adverse events (time frame: 6 months). 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 22 Jan 2016.