Osteoarthritis, KneePhase 1/2NCT04205656
Prospective Evaluation of PRP and BMC Treatment to Accelerate Healing After ACL Reconstruction
A Phase 1/2 study testing Leukocyte-Poor Platelet Rich Plasma (LP-PRP) and Bone Marrow Concentrate (BMC) in people with Osteoarthritis, Knee, run by Steadman Philippon Research Institute at 1 site in United States.
Trial summary
This is a prospective, randomized, placebo-controlled trial to evaluate potential beneficial effects of leukocyte-poor platelet rich plasma and bone marrow concentrate on the healing and health of critical joint tissues in the knee following anterior cruciate ligament (ACL) reconstruction. Read more about this study
- Who is it for?
- Ages 16 to 50 years
- Conditions the study is for
- Osteoarthritis, Knee
- What is being tested?
- Leukocyte-Poor Platelet Rich Plasma (LP-PRP) and Bone Marrow Concentrate (BMC)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 45 participants
- Where
- 1 siteUnited States
- Study dates
- 2 Jan 2020to Sep 2024
- 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 16 to 50 years
- All sexes
- No healthy volunteers
- Child, Adult
Inclusion Criteria: Subjects will be included if all the following criteria are met:
- Age 16-50 years at the time of Anterior Cruciate Ligament Reconstruction (ACLR) surgery;
- Acute ACL injury within 6 months of scheduled ACLR surgery;
- Scheduled for unilateral, primary ACLR with a BTB (bone-patellar tendon-bone) autograft;
- The following concomitant injuries are allowed:
- Meniscal injuries of all types, grades and regardless of surgical treatment;
- Articular chondral injury that can be addressed with debridement or chondroplasty;
- Tibial impaction fractures;
- Non-operative sprains/injuries of MCL or LCL;
- Willing and able to comply with all required post-operative visits, biomotion and imaging tests, the self-completion of questionnaires and other trial procedures.
Exclusion Criteria: Subjects will be excluded if any of the following criteria are met:
- Inability to provide informed consent;
- Women who are pregnant;
- Previous surgery for either knee except in cases of prior diagnostic arthroscopy and/or minimal debridement;
- Significant osteoarthritis (OA) of the knee (e.g. grade 4 with cystic changes and/or significant osteophytes);
- Concomitant cartilage restoration procedure in the operative knee;
- Biologic treatment (e.g. PRP, BMC, prolotherapy, etc.) in the operative knee within 6 months of ACLR surgery;
- Steroid injections in the operative knee within 3 months of ACLR surgery;
- Open growth plates (determined by the treating physician based on standard-of-care preoperative knee radiographs);
- History of deep vein thrombosis (DVT) or pulmonary embolism (PE) that requires additional anticoagulation beyond usual post-operative standard of care;
- Current or known history of significant active autoimmune disease (i.e. rheumatoid arthritis and SLE);
- Incompatible MRI hardware/devices and/or inability to safely undergo MRI per the MRI safety screening questionnaire;
- Known balance or vestibular disorders, if in the opinion of the Principal Investigator or delegated clinician may affect ability to safely comply with study procedures;
- History of significant radiation exposure, e.g. due to radiation therapy or occupational exposure;
- Active malignancy of any type or history of a malignancy within 2 years of informed consent (with the exception of subjects with a history of treated basal or squamous cell carcinoma);
- Concurrent or previous participation in another clinical trial within 30 days prior to informed consent;
- Concurrent enrollment in DOD Project 4, Vail Health Hospital IRB # 2018-20, is allowed while subjects on this study are in the 18-month follow-up period;
- Concurrent enrollment in non-interventional registry studies or blood-banking/biomarker studies is allowed;
- History of substance abuse (drug or alcohol) that may interfere with the subject's ability to cooperate and comply with the trial procedures;
- Severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with trial participation or investigational product administration or may interfere with the interpretation of trial results and, in the judgment of the Principal Investigator or delegated clinician, would make the subject inappropriate for entry into this trial. Subjects will be withdrawn from the study (Screen Failures) after providing informed consent and/or at the time of ACLR surgery if they meet any of the following criteria:
- Concurrent reconstruction of any knee ligaments other than the ACL;
- ACLR which requires the following concomitant treatments: bone plating, metal implants (with the exception of titanium interference screws) or microfracture;
- Inability to collect sufficient research samples (e.g. less than the minimum required amount of BMA is harvested, or clotting occurs).
Trial locations and contacts
1 site in 1 country.
United States1 site
181 West Meadow Drive, Suite 1000
Vail, Colorado, 81657-5242
About this study
Official title: Prospective Evaluation of Platelet-Rich Plasma and Bone Marrow Concentrate Treatment to Accelerate Healing After Anterior Cruciate Ligament Reconstruction
This is a prospective, randomized, placebo-controlled trial to evaluate potential beneficial effects of leukocyte-poor platelet rich plasma and bone marrow concentrate on the healing and health of critical joint tissues in the knee following anterior cruciate ligament (ACL) reconstruction. Bone marrow contains stem cells which can change into cells of various different tissue types, while platelet rich plasma contains growth factors. This trial will compare the two procedures against placebo.
Read the detailed description
This is a prospective, randomized, placebo-controlled trial. Patients will be randomized into three groups: Concentrated Bone Marrow Concentrate (BMC), Platelet-Rich Plasma (PRP) or Placebo. BMC subjects will have bone marrow aspirated from the subjects iliac crests and the cellular rich portion will be concentrated and subsequently injected into the subjects' symptomatic knee during ACL reconstruction surgery. PRP subjects will have a venous blood draw and the resulting PRP will be injected into the symptomatic knee during ACL reconstruction surgery. Follow-up visits in person will take place at 2 weeks, 6 months and 12 months after the ACL reconstruction surgery.
The purpose of this study is to evaluate potential beneficial effects of leukocyte-poor platelet-rich plasma (LP-PRP) and bone marrow concentrate (BMC) on the healing and health of all critical joint tissues (grafts/ligaments, meniscus and cartilage) in the knee following anterior cruciate ligament reconstruction (ACLR). Key aspects of this proposal include our well-developed methodologies to quantify and correlate cytokines, chemokines, growth factors in PRP and progenitor cells in BMC, clinical outcomes and imaging following ACLR. The overarching goal of this randomized control trial is to establish a biological signature of PRP and BMC that will be indicative for optimal recovery after ACLR. The long-term goal of our research is to better understand the efficacy of orthobiologic approaches to improve clinical outcomes, enhance graft healing and mitigate post-traumatic osteoarthritis (PTOA) in a cohort of patients that have undergone ACLR.
- Conditions
- Osteoarthritis, Knee
- Being tested
- Leukocyte-Poor Platelet Rich Plasma (LP-PRP), Bone Marrow Concentrate (BMC), Control group (Placebo)
- Keywords
- bone marrow concentrate (BMC), stem cell, platelet-rich plasma (PRP), anterior cruciate ligament reconstruction (ACLR)
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Leukocyte-Poor Platelet Rich Plasma (LP-PRP)Biological
Participants will have a knee injected with Platelet-Rich Plasma (PRP) obtained from a venous whole blood draw from the vein.
Bone Marrow Concentrate (BMC)Biological
Participants will have a knee injected with BMC stem cells harvested from the iliac crest
Control group (Placebo)Other
Participants will undergo ACLR surgery with no injection into their knee.
| Study group | Role | What they receive |
|---|---|---|
| Leukocyte-Poor Platelet Rich Plasma (LP-PRP) | Experimental | Participants will have a knee injected with Platelet-Rich Plasma (PRP) obtained from a venous whole blood draw from the vein. Receives: Biological: Leukocyte-Poor Platelet Rich Plasma (LP-PRP) |
| Bone Marrow Concentrate (BMC) | Experimental | Participants will have a knee injected with BMC stem cells harvested from the iliac crest Receives: Biological: Bone Marrow Concentrate (BMC) |
| Control | Placebo comparator | Patients randomized in the placebo arm will undergo their standard of care treatment and will not receive LP-PRP or BMC. Receives: Other: Control group (Placebo) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Treatment-Emergent Adverse Events
Occurrence of adverse events
Measured: 18 months
Secondary outcomes (13)
Patient reported outcome questionnaire
SF-12 Short Form General Health Survey Patient Satisfaction
Measured: screening, baseline, two weeks post-surgery, then every week for 8 weeks post-surgery; 3, 6 12 and 18 months post-surgery
Measure signature cellular profile of BMC
Flow cytometer to analyze BMC cell concentrations
Measured: Day of Surgery
Measure plasma levels of pro-inflammatory factors in BMC
Multiplex analysis of pro-inflammatory cytokines and chemokines using Luminex 200®
Measured: Day of Surgery
Measure plasma levels of pro-inflammatory factors in LP-PRP
Multiplex analysis of pro-inflammatory cytokines and chemokines using Luminex 200®
Measured: Day of Surgery
Quantitative Magnetic Resonance Imaging (MRI)
Images acquired on a 3T Siemens Magnetom Skyra-fit scanner
Measured: screening, baseline; 6 and 12 months post-surgery
DSX: three dimensional (3D) to measure motion of the knee using dynamix x-ray software
Up to three brief X-ray exposures (6 scouts x 3 frames and 2 statics x 5 frames and 24 exposures x 100 frames will be acquired)
Measured: 6 and 12 months post-surgery
Computerized tomography (CT): 3D geometry of bony anatomy using a series of x-rays
single, bilateral knee CT scan using Toshiba Aquilon Premium 160 CT scanner
Measured: 6 months post-surgery
Patient Reported Outcome questionnaire
IKDC - International Knee Documentation Committee Score
Measured: screening, baseline, two weeks post-surgery, then every week for 8 weeks post-surgery; 3, 6 12 and 18 months post-surgery
Patient Reported Outcome questionnaire
WOMAC - Western Ontario \& McMaster Universities Osteoarthritis Index
Measured: screening, baseline, two weeks post-surgery, then every week for 8 weeks post-surgery; 3, 6 12 and 18 months post-surgery
Patient Reported Outcome questionnaire
Lysholm Score
Measured: screening, baseline, two weeks post-surgery, then every week for 8 weeks post-surgery; 3, 6 12 and 18 months post-surgery
Patient Reported Outcome questionnaire
Tegner Activity Scale
Measured: screening, baseline, two weeks post-surgery, then every week for 8 weeks post-surgery; 3, 6 12 and 18 months post-surgery
Patient Reported Outcome questionnaire
NRS (NUMERICAL RATING SCALE) for Pain
Measured: screening, baseline, two weeks post-surgery, then every week for 8 weeks post-surgery; 3, 6 12 and 18 months post-surgery
Motion Assessment
3D video motion capture
Measured: screening, baseline; 6 months post-surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2019
- Study start2 Jan 2020
- Primary completionJul 2024 (estimated)
- Study completionSep 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Osteoarthritis, KneeStudies 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
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- Steadman Philippon Research Institute
- Sponsor type
- University, hospital or other
- Collaborators
- United States Department of Defense, Office of Naval Research (ONR)
- Responsible party
- Sponsor
- Investigators
- Peter Millett, MD, Principal investigator, The Steadman Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04205656
- Sponsor's protocol ID
- 2019-13
- Status last verified
- Jul 2024
- First submitted
- 4 Dec 2019
- Last updated
- 16 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 16 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Evaluation of Platelet-Rich Plasma and Bone Marrow Concentrate Treatment to Accelerate Healing After Anterior Cruciate Ligament Reconstruction
- ClinicalTrials.gov ID
- NCT04205656
- Acronym / sponsor ID
- 2019-13
- Conditions
- Osteoarthritis, Knee
- Keywords
- bone marrow concentrate (BMC), stem cell, platelet-rich plasma (PRP), anterior cruciate ligament reconstruction (ACLR)
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Steadman Philippon Research InstituteUniversity, hospital or other
- Collaborators
- United States Department of Defense, Office of Naval Research (ONR)
- Study start
- 2 Jan 2020 (actual)
- Primary completion
- Jul 2024 (estimated)
- Study completion
- Sep 2024 (estimated)
- First posted
- 19 Dec 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.
This is a prospective, randomized, placebo-controlled trial to evaluate potential beneficial effects of leukocyte-poor platelet rich plasma and bone marrow concentrate on the healing and health of critical joint tissues in the knee following anterior cruciate ligament (ACL) reconstruction. Bone marrow contains stem cells which can change into cells of various different tissue types, while platelet rich plasma contains growth factors. This trial will compare the two procedures against placebo.
Detailed description
This is a prospective, randomized, placebo-controlled trial. Patients will be randomized into three groups: Concentrated Bone Marrow Concentrate (BMC), Platelet-Rich Plasma (PRP) or Placebo. BMC subjects will have bone marrow aspirated from the subjects iliac crests and the cellular rich portion will be concentrated and subsequently injected into the subjects' symptomatic knee during ACL reconstruction surgery. PRP subjects will have a venous blood draw and the resulting PRP will be injected into the symptomatic knee during ACL reconstruction surgery. Follow-up visits in person will take place at 2 weeks, 6 months and 12 months after the ACL reconstruction surgery.
The purpose of this study is to evaluate potential beneficial effects of leukocyte-poor platelet-rich plasma (LP-PRP) and bone marrow concentrate (BMC) on the healing and health of all critical joint tissues (grafts/ligaments, meniscus and cartilage) in the knee following anterior cruciate ligament reconstruction (ACLR). Key aspects of this proposal include our well-developed methodologies to quantify and correlate cytokines, chemokines, growth factors in PRP and progenitor cells in BMC, clinical outcomes and imaging following ACLR. The overarching goal of this randomized control trial is to establish a biological signature of PRP and BMC that will be indicative for optimal recovery after ACLR. The long-term goal of our research is to better understand the efficacy of orthobiologic approaches to improve clinical outcomes, enhance graft healing and mitigate post-traumatic osteoarthritis (PTOA) in a cohort of patients that have undergone ACLR.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Leukocyte-Poor Platelet Rich Plasma (LP-PRP) | Experimental | Biological: Leukocyte-Poor Platelet Rich Plasma (LP-PRP)Participants will have a knee injected with Platelet-Rich Plasma (PRP) obtained from a venous whole blood draw from the vein. |
| Bone Marrow Concentrate (BMC) | Experimental | Biological: Bone Marrow Concentrate (BMC)Participants will have a knee injected with BMC stem cells harvested from the iliac crest |
| Control | Placebo comparator | Other: Control group (Placebo)Patients randomized in the placebo arm will undergo their standard of care treatment and will not receive LP-PRP or BMC. |
Who may qualify
- Ages
- 16 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
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 |
|---|---|---|
| Leukocyte-Poor Platelet Rich Plasma (LP-PRP)Participants will have a knee injected with Platelet-Rich Plasma (PRP) obtained from a venous whole blood draw from the vein. | Biological | Leukocyte-Poor Platelet Rich Plasma (LP-PRP) |
| Bone Marrow Concentrate (BMC)Participants will have a knee injected with BMC stem cells harvested from the iliac crest | Biological | Bone Marrow Concentrate (BMC) |
| Control group (Placebo)Participants will undergo ACLR surgery with no injection into their knee. | Other | Control |
Primary outcome
Incidence of Treatment-Emergent Adverse Events
Time frame: 18 months
Occurrence of adverse events
13 secondary outcomes
Patient reported outcome questionnaire
Time frame: screening, baseline, two weeks post-surgery, then every week for 8 weeks post-surgery; 3, 6 12 and 18 months post-surgery
Measure signature cellular profile of BMC
Time frame: Day of Surgery
Measure plasma levels of pro-inflammatory factors in BMC
Time frame: Day of Surgery
Measure plasma levels of pro-inflammatory factors in LP-PRP
Time frame: Day of Surgery
Quantitative Magnetic Resonance Imaging (MRI)
Time frame: screening, baseline; 6 and 12 months post-surgery
DSX: three dimensional (3D) to measure motion of the knee using dynamix x-ray software
Time frame: 6 and 12 months post-surgery
Computerized tomography (CT): 3D geometry of bony anatomy using a series of x-rays
Time frame: 6 months post-surgery
Patient Reported Outcome questionnaire
Time frame: screening, baseline, two weeks post-surgery, then every week for 8 weeks post-surgery; 3, 6 12 and 18 months post-surgery
Patient Reported Outcome questionnaire
Time frame: screening, baseline, two weeks post-surgery, then every week for 8 weeks post-surgery; 3, 6 12 and 18 months post-surgery
Patient Reported Outcome questionnaire
Time frame: screening, baseline, two weeks post-surgery, then every week for 8 weeks post-surgery; 3, 6 12 and 18 months post-surgery
Patient Reported Outcome questionnaire
Time frame: screening, baseline, two weeks post-surgery, then every week for 8 weeks post-surgery; 3, 6 12 and 18 months post-surgery
Patient Reported Outcome questionnaire
Time frame: screening, baseline, two weeks post-surgery, then every week for 8 weeks post-surgery; 3, 6 12 and 18 months post-surgery
Motion Assessment
Time frame: screening, baseline; 6 months post-surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jul 2024.
- Individual participant dataSharing planned: Undecided
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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.
Peter Millett, MD principal investigator
The Steadman Clinic
1 site 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 Leukocyte-Poor Platelet Rich Plasma (LP-PRP) and Bone Marrow Concentrate (BMC) in people with Osteoarthritis, Knee, run by Steadman Philippon Research Institute 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?
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 Jul 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 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. Some participants in this study may receive a placebo. 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?
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?
Incidence of Treatment-Emergent Adverse Events (time frame: 18 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 16 Jul 2024.