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Stem Cell Therapy

PRP + BMC for ACL Reconstruction Healing

Phase 1 & 2

Recruiting

Led By Peter Millett, MD

Research Sponsored by Steadman Philippon Research Institute

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Age 16-50 years at the time of Anterior Cruciate Ligament Reconstruction (ACLR) surgery;

Concurrent reconstruction of any knee ligaments other than the ACL;

Timeline

Screening 3 weeks

Treatment Varies

Follow Up screening, baseline, two weeks post-surgery, then every week for 8 weeks post-surgery; 3, 6 12 and 18 months post-surgery

Awards & highlights

Study Summary

This trial will compare the effects of two procedures, 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, against placebo.

Who is the study for?

This trial is for individuals aged 16-50 with ACL injuries scheduled for reconstruction using their own tissue. They must have certain types of knee injuries but no severe osteoarthritis, previous significant knee surgeries, or treatments like PRP in the last 6 months. Pregnant women and those with open growth plates or autoimmune diseases are excluded.Check my eligibility

What is being tested?

The study tests if Bone Marrow Concentrate (BMC) or Leukocyte-Poor Platelet Rich Plasma (LP-PRP), which contain stem cells and growth factors respectively, can improve healing after ACL surgery compared to a placebo control group.See study design

What are the potential side effects?

Potential side effects may include discomfort at injection sites, infection risk from injections, allergic reactions to components used in BMC or LP-PRP preparations, and possible unknown risks associated with these biological treatments.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am between 16 and 50 years old and need ACL surgery.

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I am not having surgery on knee ligaments other than the ACL.

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I have a joint injury that can be treated by cleaning or repairing the cartilage.

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I have a tibial impaction fracture.

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I have a sprain or injury in my knee ligament that didn't require surgery.

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I have a tibial impaction fracture.

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I understand I may be removed from the study if certain conditions are met during surgery.

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I have a joint injury that can be treated by cleaning or repairing the cartilage.

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I am scheduled for ACL surgery using a part of my kneecap tendon.

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I have a meniscal injury, no matter its type or if it was treated surgically.

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I have a meniscal injury, no matter its type or if it was treated surgically.

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My ACL repair will involve bone plating, metal implants (except titanium screws), or microfracture.

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I have a sprain or injury in my knee ligaments that doesn't require surgery.

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I am scheduled for ACL surgery using a part of my own knee.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ screening, baseline, two weeks post-surgery, then every week for 8 weeks post-surgery; 3, 6 12 and 18 months post-surgery

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~screening, baseline, two weeks post-surgery, then every week for 8 weeks post-surgery; 3, 6 12 and 18 months post-surgery

This trial's timeline: 3 weeks for screening, Varies for treatment, and screening, baseline, two weeks post-surgery, then every week for 8 weeks post-surgery; 3, 6 12 and 18 months post-surgery for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Incidence of Treatment-Emergent Adverse Events

Secondary outcome measures

Computerized tomography (CT): 3D geometry of bony anatomy using a series of x-rays

DSX: three dimensional (3D) to measure motion of the knee using dynamix x-ray software

Measure plasma levels of pro-inflammatory factors in BMC

+6 more

Trial Design

3Treatment groups

Experimental Treatment

Placebo Group

Group I: Leukocyte-Poor Platelet Rich Plasma (LP-PRP)Experimental Treatment1 Intervention

Participants will have a knee injected with Platelet-Rich Plasma (PRP) obtained from a venous whole blood draw from the vein.

Group II: Bone Marrow Concentrate (BMC)Experimental Treatment1 Intervention

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

Group III: ControlPlacebo Group1 Intervention

Patients randomized in the placebo arm will undergo their standard of care treatment and will not receive LP-PRP or BMC.

0 / 14Eligibility criteria met

Find a Location

Who is running the clinical trial?

Steadman Philippon Research InstituteLead Sponsor

9 Previous Clinical Trials

516 Total Patients Enrolled

2 Trials studying Osteoarthritis

175 Patients Enrolled for Osteoarthritis

United States Department of DefenseFED

865 Previous Clinical Trials

327,600 Total Patients Enrolled

3 Trials studying Osteoarthritis

155 Patients Enrolled for Osteoarthritis

Office of Naval Research (ONR)FED

14 Previous Clinical Trials

623 Total Patients Enrolled

1 Trials studying Osteoarthritis

75 Patients Enrolled for Osteoarthritis

Media Library

Bone Marrow Concentrate (BMC) (Stem Cell Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT04205656 — Phase 1 & 2

Osteoarthritis Research Study Groups: Control, Bone Marrow Concentrate (BMC), Leukocyte-Poor Platelet Rich Plasma (LP-PRP)

Osteoarthritis Clinical Trial 2023: Bone Marrow Concentrate (BMC) Highlights & Side Effects. Trial Name: NCT04205656 — Phase 1 & 2

Bone Marrow Concentrate (BMC) (Stem Cell Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04205656 — Phase 1 & 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

May those aged 85 years and below partake in this research?

"This trial is accepting patients aged 16 to 50. There are an additional 27 studies for minors and 429 studies open to seniors."

Answered by AI

Is the enrollment for this investigation still open?

"Per the official listing on clinicaltrials.gov, this investigation is currently seeking participants to join. The study was initiated in January 2020 and last revised March 1st 2022."

Answered by AI

To whom is participation in this research endeavor open?

"This medical trial, open to persons 16-50 years of age with a diagnosis of osteoarthritis in the knee joint, is actively recruiting 99 participants. Eligible patients must consent to postoperative appointments and tests, non-surgical sprains/injuries of MCL or LCL, meniscal injuries regardless of treatment type and articular chondral injury that can be addressed via debridement or chondroplasty."

Answered by AI

To what extent is participation in this research project being pursued?

"Affirmative. According to clinicaltrials.gov, the trial that was made available on 2nd January 2020 is currently seeking participants and has been recently updated on 1st March 2022. The study requires 99 individuals from a single site."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

2020. "Prospective Evaluation of PRP and BMC Treatment to Accelerate Healing After ACL Reconstruction". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04205656.

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