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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.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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:

  1. Age 16-50 years at the time of Anterior Cruciate Ligament Reconstruction (ACLR) surgery;
  2. Acute ACL injury within 6 months of scheduled ACLR surgery;
  3. Scheduled for unilateral, primary ACLR with a BTB (bone-patellar tendon-bone) autograft;
  4. The following concomitant injuries are allowed:
  5. Meniscal injuries of all types, grades and regardless of surgical treatment;
  6. Articular chondral injury that can be addressed with debridement or chondroplasty;
  7. Tibial impaction fractures;
  8. Non-operative sprains/injuries of MCL or LCL;
  9. 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:

  1. Inability to provide informed consent;
  2. Women who are pregnant;
  3. Previous surgery for either knee except in cases of prior diagnostic arthroscopy and/or minimal debridement;
  4. Significant osteoarthritis (OA) of the knee (e.g. grade 4 with cystic changes and/or significant osteophytes);
  5. Concomitant cartilage restoration procedure in the operative knee;
  6. Biologic treatment (e.g. PRP, BMC, prolotherapy, etc.) in the operative knee within 6 months of ACLR surgery;
  7. Steroid injections in the operative knee within 3 months of ACLR surgery;
  8. Open growth plates (determined by the treating physician based on standard-of-care preoperative knee radiographs);
  9. History of deep vein thrombosis (DVT) or pulmonary embolism (PE) that requires additional anticoagulation beyond usual post-operative standard of care;
  10. Current or known history of significant active autoimmune disease (i.e. rheumatoid arthritis and SLE);
  11. Incompatible MRI hardware/devices and/or inability to safely undergo MRI per the MRI safety screening questionnaire;
  12. 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;
  13. History of significant radiation exposure, e.g. due to radiation therapy or occupational exposure;
  14. 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);
  15. Concurrent or previous participation in another clinical trial within 30 days prior to informed consent;
  16. 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;
  17. Concurrent enrollment in non-interventional registry studies or blood-banking/biomarker studies is allowed;
  18. History of substance abuse (drug or alcohol) that may interfere with the subject's ability to cooperate and comply with the trial procedures;
  19. 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:
  20. Concurrent reconstruction of any knee ligaments other than the ACL;
  21. ACLR which requires the following concomitant treatments: bone plating, metal implants (with the exception of titanium interference screws) or microfracture;
  22. 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

Other trials in United States

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.

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 groups in NCT04205656
Study groupRoleWhat they receive
Leukocyte-Poor Platelet Rich Plasma (LP-PRP)ExperimentalParticipants 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)ExperimentalParticipants will have a knee injected with BMC stem cells harvested from the iliac crest
Receives: Biological: Bone Marrow Concentrate (BMC)
ControlPlacebo comparatorPatients 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.

  1. Incidence of Treatment-Emergent Adverse Events

    Occurrence of adverse events

    Measured: 18 months

Secondary outcomes (13)
  1. 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

  2. Measure signature cellular profile of BMC

    Flow cytometer to analyze BMC cell concentrations

    Measured: Day of Surgery

  3. Measure plasma levels of pro-inflammatory factors in BMC

    Multiplex analysis of pro-inflammatory cytokines and chemokines using Luminex 200®

    Measured: Day of Surgery

  4. 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

  5. Quantitative Magnetic Resonance Imaging (MRI)

    Images acquired on a 3T Siemens Magnetom Skyra-fit scanner

    Measured: screening, baseline; 6 and 12 months post-surgery

  6. 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

  7. 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

  8. 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

  9. 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

  10. 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

  11. 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

  12. 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

  13. 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.

  1. First posted19 Dec 2019
  2. Study start2 Jan 2020
  3. Primary completionJul 2024 (estimated)
  4. Study completionSep 2024 (estimated)

Resources

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)
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

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.

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