Prospective Evaluation of PRP and BMC Treatment to Accelerate Healing After ACL Reconstruction

NCT04205656 | Active Not Recruiting Phase 1

• 1 other identifier: 2019-13
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Osteoarthritis, Knee

Keywords

bone marrow concentrate (BMC); stem cell; platelet-rich plasma (PRP); anterior cruciate ligament reconstruction (ACLR)

Outcome Measures

Primary Outcomes (1)

• Incidence of Treatment-Emergent Adverse Events

  Occurrence of adverse events

  18 months

Secondary Outcomes (13)

• Patient reported outcome questionnaire

  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

  Day of Surgery

• Measure plasma levels of pro-inflammatory factors in BMC

  Day of Surgery

• Measure plasma levels of pro-inflammatory factors in LP-PRP

  Day of Surgery

• Quantitative Magnetic Resonance Imaging (MRI)

  screening, baseline; 6 and 12 months post-surgery

Study Arms (3)

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.

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

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.

Other: Control group (Placebo)

Interventions

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.

Leukocyte-Poor Platelet Rich Plasma (LP-PRP)

Bone Marrow Concentrate (BMC) BIOLOGICAL

Participants will have a knee injected with BMC stem cells harvested from the iliac crest

Bone Marrow Concentrate (BMC)

Control group (Placebo) OTHER

Participants will undergo ACLR surgery with no injection into their knee.

Control

Eligibility Criteria

• Age: 16 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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;

Sponsors & Collaborators

• Steadman Philippon Research Institute: lead
• United States Department of Defense: collaborator
• Office of Naval Research (ONR): collaborator

Study Sites (1)

181 West Meadow Drive, Suite 1000

Vail, Colorado, 81657-5242, United States

Location

MeSH Terms

Conditions

Osteoarthritis, Knee

Interventions

Control Groups

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Study Officials

• Peter Millett, MD

  The Steadman Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Outcomes assessor
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 4, 2019
• First Posted: December 19, 2019
• Study Start: January 2, 2020
• Primary Completion: July 1, 2024
• Study Completion: September 1, 2024
• Last Updated: July 16, 2024

Record last verified: 2024-07

Locations

US (1)