Osteoarthritis, KneeNCT03242707
Intra-articular Adipose Tissue Injections for Osteoarthritis
A study testing Autologous adipose tissue injection and Hyaluronic Acid in people with Osteoarthritis, Knee, run by University of Southern California at 1 site in United States.
Trial summary
A new generation of "minimally manipulated" regenerative treatments are being offered at clinics across the country, but there is no strong efficacy data to support their use. The purpose of this study is to estimate the effect size of the treatment by comparing the efficacy of autologous fat to the current standard… Read more about this study
- Who is it for?
- Ages 45 to 75 years
- Conditions the study is for
- Osteoarthritis, Knee
- What is being tested?
- Autologous adipose tissue injection and Hyaluronic Acid
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 54 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jul 2018to 1 Dec 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 45 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 45 to 75, inclusive
- Normal axial alignment
- X-ray, Kellgren-Lawrence OA grade 2 - 3, inclusive
- WOMAC-pain: Between 9 and 19, inclusive
- Willingness to participate all scheduled follow-ups
- Willingness to refrain from taking NSAIDs, level 2 analgesics, and opioids for the course of the study
- BMI < 40
Who cannot join
- Pregnant or lactating
- Intra-articular injection within 3 months of treatment
- Inflammatory arthritis
- Any disease or active drug use that significantly compromises coagulation
- Significant damage and/or tears of the ACL or other supporting tissues
- Prior knee surgery in the last 6 months in the knee that will be injected
Show all 13Show fewer
- Active tobacco use
- Active alcohol or substance abuse within 6 months of study entry
- Known hypersensitivity (allergy) to hyaluronan (sodium hyaluronate) preparations
- Knee joint infections, skin diseases or infections in the area of the injection site
- Diabetes
- Active inhaler use
- Any medical condition, which in the opinion of the clinical investigator, would interfere with the treatment or outcome evaluation
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Keck Medicine of USC
Los Angeles, California, 90033
William Fang, 323-442-6959, williahf@usc.edu
About this study
Official title: A Randomized, Controlled Study to Evaluate the Efficacy of Intra-articular, Autologous Adipose Tissue Injections for the Treatment of Mild-to-Moderate Osteoarthritis
A new generation of "minimally manipulated" regenerative treatments are being offered at clinics across the country, but there is no strong efficacy data to support their use. The purpose of this study is to estimate the effect size of the treatment by comparing the efficacy of autologous fat to the current standard of care treatment, hyaluronic acid (HA). As a secondary aim, we will test for preliminary evidence of efficacy of autologous fat vs. HA and determine how these treatments effect the biochemical environment of the knee by comparing pre-injection and post-injection synovial fluid biomarker profiles.
Read the detailed description
In recent years, fat treatments administered for structural reconstruction, repair, or replacement are being increasingly offered at clinics across the country. These treatments contain both autologous cells that are often referred to as "stem cells" or "MSCs" and extra-cellular matrix (ECM). Cell therapies containing ECM are thought to have the following advantages over treatments prepared using enzymatic digestion: (1) preservation of the stromal vascular niche, which allows time-release of the regenerative factors; (2) release of bioactive molecules by exosomes, which have been demonstrated to be significantly greater in mechanically processed fat than enzymatically processed fat; and (3) maintenance of the structural and morphologic unit, which is thought to increase cell efficacy by making the cells more resilient to the harsh conditions in the recipient environment. Case reports investigating the use of autologous fat treatments show promise, but a number of questions remain unanswered. Agents injected into the joint tend to be quickly cleared from the body and ECM itself has the potential to produce inflammatory signals and induce osteoarthritis.
This study will use a Hyaluronic acid (HA) as an active control, which is the standard of care for pain associated with osteoarthritis. The use of HA as an active control for autologous cell-based therapies is well established and is the best option given the need to aspirate fat tissue from patients who will be receiving the study treatment.
- Conditions
- Osteoarthritis, Knee
- Being tested
- Autologous adipose tissue injection, Hyaluronic Acid
- 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 injectionBiological
Also called Lipogems, Microfragmented fat
20ml to 40ml of subcutaneous adipose tissue will be aspirated from the abdomen. Adipose tissue will be processed using the Lipogems device, a closed-loop processing device used in medical procedures involving the harvesting, concentrating and transferring of autologous adipose tissue.
The resulting fat product will be delivered locally via ultrasound-guided, intra-articular injection.
Hyaluronic AcidDrug
Synvisc-One® is a high molecular weight sodium hyaluronate.
| Study group | Role | What they receive |
|---|---|---|
| Autologous adipose tissue knee injection | Experimental | Fat will be removed from the abdomen and processed using the Lipogems device. Approximately 5ml of the microfragmented fat product will be injected into the knee joint. Receives: Biological: Autologous adipose tissue injection |
| Hyaluronic Acid knee injection | Active comparator | Hyaluronic Acid - Synvisc-One®: A high molecular weight sodium hyaluronate (HA). HA is an FDA approved, standard of care treatment. Receives: Drug: Hyaluronic Acid |
What is being measured
The primary outcome is the main question the study is designed to answer.
The pain items of then Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC-A)
WOMAC-A is a widely used, proprietary set of standardized questionnaires used by health professionals to evaluate the condition of patients with osteoarthritis of the knee and hip, including pain.
Measured: Change from baseline WOMAC score at 6 months
Secondary outcomes (3)
Patient-Reported Outcomes Measurement Information System 29-item (PROMIS®-29)
A collection of 4-item short forms assessing anxiety, depression, fatigue, pain interference, physical function, sleep disturbance, and ability to participate in social roles and activities as well as a single pain intensity item.
Measured: Change from baseline in PROMIS-29 from baseline to 6 months
Western Ontario and McMaster Universities Osteoarthritis Index
WOMAC is a widely used, proprietary set of standardized questionnaires used by health professionals to evaluate the condition of patients with osteoarthritis of the knee and hip, including pain, stiffness, and physical functioning of the joints.
Measured: Change from baseline in PROMIS-29 from baseline to 6 months
Clinical Anchors
Clinical anchors will be used to identify minimal important differences in treatment groups
Measured: Clinical anchors from baseline to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Aug 2017
- Study start1 Jul 2018
- Primary completion1 Dec 2019 (estimated)
- Study completion1 Dec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Osteoarthritis, KneeStudies of the same condition, open and under way.
- More trials run by University of Southern CaliforniaThe 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
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants will be randomly assigned to receive either a single autologous fat injection or a single hyaluronic acid injection.
- Masking
- None (open label)
- Enrolment
- 54 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Southern California
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Thomas Vangsness, University of Southern California
- Investigators
- C.Thomas Vangsness, MD, Principal investigator, Keck School of Medicine of USC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03242707
- Sponsor's protocol ID
- HS-17-00365
- Status last verified
- Oct 2019
- First submitted
- 28 Jul 2017
- Last updated
- 3 Oct 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Jones IA, Wilson M, Togashi R, Han B, Mircheff AK, Thomas Vangsness C Jr. A randomized, controlled study to evaluate the efficacy of intra-articular, autologous adipose tissue injections for the treatment of mild-to-moderate knee osteoarthritis compared to hyaluronic acid: a study protocol. BMC Musculoskelet Disord. 2018 Oct 24;19(1):383. doi: 10.1186/s12891-018-2300-7.
PubMed 30355323
Study at a glance
From the registry record, last updated by the sponsor on 3 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Controlled Study to Evaluate the Efficacy of Intra-articular, Autologous Adipose Tissue Injections for the Treatment of Mild-to-Moderate Osteoarthritis
- ClinicalTrials.gov ID
- NCT03242707
- Acronym / sponsor ID
- HS-17-00365
- Conditions
- Osteoarthritis, Knee
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 54 participants (estimated)
- Lead sponsor
- University of Southern CaliforniaUniversity, hospital or other
- Study start
- 1 Jul 2018 (actual)
- Primary completion
- 1 Dec 2019 (estimated)
- Study completion
- 1 Dec 2020 (estimated)
- First posted
- 8 Aug 2017 (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.
A new generation of "minimally manipulated" regenerative treatments are being offered at clinics across the country, but there is no strong efficacy data to support their use. The purpose of this study is to estimate the effect size of the treatment by comparing the efficacy of autologous fat to the current standard of care treatment, hyaluronic acid (HA). As a secondary aim, we will test for preliminary evidence of efficacy of autologous fat vs. HA and determine how these treatments effect the biochemical environment of the knee by comparing pre-injection and post-injection synovial fluid biomarker profiles.
Detailed description
In recent years, fat treatments administered for structural reconstruction, repair, or replacement are being increasingly offered at clinics across the country. These treatments contain both autologous cells that are often referred to as "stem cells" or "MSCs" and extra-cellular matrix (ECM). Cell therapies containing ECM are thought to have the following advantages over treatments prepared using enzymatic digestion: (1) preservation of the stromal vascular niche, which allows time-release of the regenerative factors; (2) release of bioactive molecules by exosomes, which have been demonstrated to be significantly greater in mechanically processed fat than enzymatically processed fat; and (3) maintenance of the structural and morphologic unit, which is thought to increase cell efficacy by making the cells more resilient to the harsh conditions in the recipient environment. Case reports investigating the use of autologous fat treatments show promise, but a number of questions remain unanswered. Agents injected into the joint tend to be quickly cleared from the body and ECM itself has the potential to produce inflammatory signals and induce osteoarthritis.
This study will use a Hyaluronic acid (HA) as an active control, which is the standard of care for pain associated with osteoarthritis. The use of HA as an active control for autologous cell-based therapies is well established and is the best option given the need to aspirate fat tissue from patients who will be receiving the study treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Participants will be randomly assigned to receive either a single autologous fat injection or a single hyaluronic acid injection.
| Arm | Type | Receives |
|---|---|---|
| Autologous adipose tissue knee injection | Experimental | Biological: Autologous adipose tissue injectionFat will be removed from the abdomen and processed using the Lipogems device. Approximately 5ml of the microfragmented fat product will be injected into the knee joint. |
| Hyaluronic Acid knee injection | Active comparator | Drug: Hyaluronic AcidHyaluronic Acid - Synvisc-One®: A high molecular weight sodium hyaluronate (HA). HA is an FDA approved, standard of care treatment. |
Who may qualify
- Ages
- 45 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Age 45 to 75, inclusive
- Normal axial alignment
- X-ray, Kellgren-Lawrence OA grade 2 - 3, inclusive
- WOMAC-pain: Between 9 and 19, inclusive
- Willingness to participate all scheduled follow-ups
Key exclusion criteria (13 listed)
- Pregnant or lactating
- Intra-articular injection within 3 months of treatment
- Inflammatory arthritis
- Any disease or active drug use that significantly compromises coagulation
- Significant damage and/or tears of the ACL or other supporting tissues
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 injectionAlso: Lipogems, Microfragmented fat20ml to 40ml of subcutaneous adipose tissue will be aspirated from the abdomen. Adipose tissue will be processed using the Lipogems device, a closed-loop processing device used in medical procedures involving the harvesting, concentrating and transferring of autologous adipose tissue. The resulting fat product will be delivered locally via ultrasound-guided, intra-articular injection. | Biological | Autologous adipose tissue knee injection |
| Hyaluronic AcidSynvisc-One® is a high molecular weight sodium hyaluronate. | Drug | Hyaluronic Acid knee injection |
Primary outcome
The pain items of then Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC-A)
Time frame: Change from baseline WOMAC score at 6 months
WOMAC-A is a widely used, proprietary set of standardized questionnaires used by health professionals to evaluate the condition of patients with osteoarthritis of the knee and hip, including pain.
3 secondary outcomes
Patient-Reported Outcomes Measurement Information System 29-item (PROMIS®-29)
Time frame: Change from baseline in PROMIS-29 from baseline to 6 months
Western Ontario and McMaster Universities Osteoarthritis Index
Time frame: Change from baseline in PROMIS-29 from baseline to 6 months
Clinical Anchors
Time frame: Clinical anchors from baseline to 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Oct 2019.
- Derived from this study: PubMed 30355323Jones IA, Wilson M, Togashi R, Han B, Mircheff AK, Thomas Vangsness C Jr. A randomized, controlled study to evaluate the efficacy of intra-articular, autologous adipose tissue injections for the treatment of mild-to-moderate knee osteoarthritis compared to hyaluronic acid: a study protocol. BMC Musculoskelet Disord. 2018 Oct 24;19(1):383. doi: 10.1186/s12891-018-2300-7.
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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.
C.Thomas Vangsness, MD principal investigator
Keck School of Medicine of USC
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 tissue injection and Hyaluronic Acid in people with Osteoarthritis, Knee, run by University of Southern California at 1 site in United States.
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 13 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 3 Oct 2019. 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 United States. 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?
Contact William Fang (323-442-6959, williahf@usc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The pain items of then Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC-A) (time frame: Change from baseline WOMAC score at 6 months). 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 NCT03242707, which also lists 1 linked publication.
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 3 Oct 2019.