Knee OsteoarthritisNCT03014401
The Effect of Adipose-Derived Stem Cells for Knee Osteoarthritis
A study testing Arthroscopic debridement with stem cell transplantation and Arthroscopic debridement only in people with Knee Osteoarthritis, run by University of Colorado, Denver at 3 sites in United States.
Trial summary
The purpose of this study is to compare the clinical and functional outcomes of patients with mild to moderate arthroscopically confirmed osteoarthritis between the following two groups: 1. Read more about this study
- Who is it for?
- Ages 35 to 70 years
- Conditions the study is for
- Knee Osteoarthritis
- What is being tested?
- Arthroscopic debridement with stem cell transplantation and Arthroscopic debridement only
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 29 participants
- Where
- 3 sitesUnited States
- Study dates
- May 2016to Dec 2025
- 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 35 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age between 35 and 70 years-old
- Patient is scheduled to undergo one or a combination of the following procedures:
- Meniscal debridement or partial menisectomy
- Meniscal repair that does not necessitate a different postoperative protocol from meniscal debridement or partial menisectomy
- Removal of loose bodies
- Chondroplasty
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- Synovectomy
- Soft tissue releases for flexion or extension contracture.
- Diagnosis of pre-existing mild to moderate osteoarthritis of the medial or lateral femoral condyle (Kellgren-Lawrence Grade 2 or 3)
- < 6 months of knee pain or < 6 months of a significant exacerbation of existing knee pain
- Physical examination findings consistent with the proposed surgical procedure.
- Failure of conservative therapy consisting of a minimum of 6 weeks of physical therapy and trial of anti-inflammatory medications, with or without concomitant bracing and/or injections
Who cannot join
- Age < 35 or > 70 years old
- Radiographs demonstrating either no, little or severe osteoarthritis (Kellgren-Lawrence Grade 0, 1 or 4)
- Previous injury or surgery to the infrapatellar fat pad (assessed by MRI)
- Patient scheduled to undergo any concomitant surgical procedures with the exception of:
- Meniscal debridement or partial menisectomy
- Meniscal repair that does not necessitate a different postoperative protocol from meniscal debridement or partial menisectomy
Show all 13Show fewer
- Removal of loose bodies
- Chondroplasty
- Synovectomy
- Soft tissue releases for flexion or extension contracture
- Prior surgery on ipsilateral knee involving cartilage regeneration (microfracture, Autologous Chondrocyte Implantation, etc) or meniscal transplant/implant
- Previous arthroscopy within 1 year
- Subchondral edema
Trial locations and contacts
3 sites in 1 country.
United States3 sites, 2 recruiting
- Recruiting
UC Health Steadman Hawkins Clinic - Denver Inverness
Denver, Colorado, 80112
Kaitlyn Whitney, 720-872-4836, Inverness.clinicaltrial@cuanschutz.edu
- Recruiting
Kerlan Jobe Orthopedic Institute
Santa Monica, California, 90404
Jasmine Galloway, B.S., 310-829-2663, jasmine.galloway@cskerlanjobe.org
Burt Mandelbaum, M.D.
- Active, not recruiting
Stanford University
Stanford, California, 94305
About this study
Official title: The Effect of Adipose-Derived Stem Cells for Knee Osteoarthritis: A Randomized Controlled Trial
The purpose of this study is to compare the clinical and functional outcomes of patients with mild to moderate arthroscopically confirmed osteoarthritis between the following two groups:
- Partial fat pad harvest with Adipose-Derived Stem Cell (ADSC) transplantation with standard arthroscopic treatment consisting of: partial meniscectomy, cartilage stabilization, loose body removal and selective synovectomy.
- Standard arthroscopic treatment (above) without cell transplant.
Read the detailed description
Adipose-derived stem cells (ADSC) may be beneficial to patients with OA because they may differentiate into chondrocytes, promote endogenous tissue repair, and have potent anti-inflammatory properties.
Early studies show promising clinical results using ADSCs to treat patients with osteoarthritis, but no clinical trials have been completed comparing cellular therapy to standard arthroscopic treatment.
The investigators aim to determine whether ADSC transplantation as adjuvant therapy in patients with arthroscopic findings of mild to moderate arthritis will result in improved clinical outcomes scores at one and two-year follow-up compared to standard arthroscopic treatment.
- Conditions
- Knee Osteoarthritis
- Being tested
- Arthroscopic debridement with stem cell transplantation, Arthroscopic debridement only
- Keywords
- stem cell, knee pain, osteoarthritis, arthritis, ADSC, fat stem cell
- Medical subject headings
- Osteoarthritis, Knee, Osteoarthritis, Arthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Arthroscopic debridement with stem cell transplantationProcedure or surgery
Autologous fat pad harvest and transplantation of cells after standard arthroscopic treatment consisting of: partial meniscectomy, synovectomy, chondroplasty, loose body removal.
Arthroscopic debridement onlyProcedure or surgery
standard arthroscopic treatment consisting of: partial meniscectomy, synovectomy, chondroplasty, loose body removal.
| Study group | Role | What they receive |
|---|---|---|
| Stem Cells | Experimental | Fat pad harvest with stem cell transplantation and standard arthroscopic debridement. Receives: Procedure: Arthroscopic debridement with stem cell transplantation |
| Placebo | Active comparator | Standard arthroscopic debridement with fat pad harvest WITHOUT stem cell transplantation Receives: Procedure: Arthroscopic debridement only |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative KOOS (Knee Injury and Osteoarthritis Outcome Score) score 24 months following surgery
Patient reported outcomes measures; Score ranges 0-100, with 100 being healthy/normal
Measured: The study will end after 24 month follow-up is completed in all participants.
Secondary outcomes (3)
Tegner score
Patient reported outcomes measures
Measured: 6, 12, 24 months
Lysholm score
Patient reported outcomes measures
Measured: 6, 12, 24 months
VR-12
Patient reported outcomes measures
Measured: 6, 12, 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jan 2017 (estimated)
- Study startMay 2016
- Primary completionDec 2025 (estimated)
- Study completionDec 2025 (estimated)
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.
- More trials run by University of Colorado, DenverThe 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
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 29 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Colorado, Denver
- Sponsor type
- University, hospital or other
- Collaborators
- Stanford University
- Responsible party
- Sponsor
- Investigators
- Jason L Dragoo, MD, Principal investigator, University of Colorado, DenverSeth L Sherman, MD, Principal investigator, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03014401
- Sponsor's protocol ID
- 19-2893
- Status last verified
- Apr 2024
- First submitted
- 20 Dec 2016
- Last updated
- 25 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Adipose-Derived Stem Cells for Knee Osteoarthritis: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03014401
- Acronym / sponsor ID
- 19-2893
- Conditions
- Knee Osteoarthritis
- Keywords
- stem cell, knee pain, osteoarthritis, arthritis, ADSC, fat stem cell
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 29 participants (estimated)
- Lead sponsor
- University of Colorado, DenverUniversity, hospital or other
- Collaborators
- Stanford University
- Study start
- May 2016
- Primary completion
- Dec 2025 (estimated)
- Study completion
- Dec 2025 (estimated)
- First posted
- 9 Jan 2017 (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.
The purpose of this study is to compare the clinical and functional outcomes of patients with mild to moderate arthroscopically confirmed osteoarthritis between the following two groups:
- Partial fat pad harvest with Adipose-Derived Stem Cell (ADSC) transplantation with standard arthroscopic treatment consisting of: partial meniscectomy, cartilage stabilization, loose body removal and selective synovectomy.
- Standard arthroscopic treatment (above) without cell transplant.
Detailed description
Adipose-derived stem cells (ADSC) may be beneficial to patients with OA because they may differentiate into chondrocytes, promote endogenous tissue repair, and have potent anti-inflammatory properties.
Early studies show promising clinical results using ADSCs to treat patients with osteoarthritis, but no clinical trials have been completed comparing cellular therapy to standard arthroscopic treatment.
The investigators aim to determine whether ADSC transplantation as adjuvant therapy in patients with arthroscopic findings of mild to moderate arthritis will result in improved clinical outcomes scores at one and two-year follow-up compared to standard arthroscopic treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Stem Cells | Experimental | Procedure: Arthroscopic debridement with stem cell transplantationFat pad harvest with stem cell transplantation and standard arthroscopic debridement. |
| Placebo | Active comparator | Procedure: Arthroscopic debridement onlyStandard arthroscopic debridement with fat pad harvest WITHOUT stem cell transplantation |
Who may qualify
- Ages
- 35 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Age between 35 and 70 years-old
- Patient is scheduled to undergo one or a combination of the following procedures:
- Diagnosis of pre-existing mild to moderate osteoarthritis of the medial or lateral femoral condyle (Kellgren-Lawrence Grade 2 or 3)
- < 6 months of knee pain or < 6 months of a significant exacerbation of existing knee pain
- Physical examination findings consistent with the proposed surgical procedure.
Key exclusion criteria (13 listed)
- Age < 35 or > 70 years old
- Radiographs demonstrating either no, little or severe osteoarthritis (Kellgren-Lawrence Grade 0, 1 or 4)
- Previous injury or surgery to the infrapatellar fat pad (assessed by MRI)
- Patient scheduled to undergo any concomitant surgical procedures with the exception of:
- Prior surgery on ipsilateral knee involving cartilage regeneration (microfracture, Autologous Chondrocyte Implantation, etc) or meniscal transplant/implant
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 |
|---|---|---|
| Arthroscopic debridement with stem cell transplantationAutologous fat pad harvest and transplantation of cells after standard arthroscopic treatment consisting of: partial meniscectomy, synovectomy, chondroplasty, loose body removal. | Procedure or surgery | Stem Cells |
| Arthroscopic debridement onlystandard arthroscopic treatment consisting of: partial meniscectomy, synovectomy, chondroplasty, loose body removal. | Procedure or surgery | Placebo |
Primary outcome
Postoperative KOOS (Knee Injury and Osteoarthritis Outcome Score) score 24 months following surgery
Time frame: The study will end after 24 month follow-up is completed in all participants.
Patient reported outcomes measures; Score ranges 0-100, with 100 being healthy/normal
3 secondary outcomes
Tegner score
Time frame: 6, 12, 24 months
Lysholm score
Time frame: 6, 12, 24 months
VR-12
Time frame: 6, 12, 24 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Apr 2024.
- Individual participant dataSharing planned: No
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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.
Jason L Dragoo, MD principal investigator
University of Colorado, Denver
Seth L Sherman, MD principal investigator
Stanford University
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Arthroscopic debridement with stem cell transplantation and Arthroscopic debridement only in people with Knee Osteoarthritis, run by University of Colorado, Denver at 3 sites 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 12 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 25 Apr 2024. 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 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 Kaitlyn Whitney ((720) 872-4836, Inverness.clinicaltrials@cuanschutz.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postoperative KOOS (Knee Injury and Osteoarthritis Outcome Score) score 24 months following surgery (time frame: The study will end after 24 month follow-up is completed in all participants.). 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 25 Apr 2024.