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Mesenchymal Stem Cell Therapy
Stem Cell Therapy for Knee Osteoarthritis
Phase 1 & 2
Waitlist Available
Led By Michael A Scarpone, D.O.
Research Sponsored by Next Generation Regenerative Medicine LLC
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
X-rays that demonstrate OA with the Kellgren-Lawrence grading scale of 2, 3 or 4 in at least one compartment of the knee either or both knees. Only subjects that have a single symptomatic knee will be enrolled
Healthy, non-smoking, males and females.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 months
Awards & highlights
Study Summary
This trial is testing whether a stem cell injection can help knee pain from osteoarthritis better than a steroid injection.
Who is the study for?
Adults aged 18-80 with knee osteoarthritis, who have not smoked and are not pregnant. They must have tried at least two conservative treatments like physical therapy or anti-inflammatory drugs without success, be within a certain weight and BMI range, and have no major heart, liver, kidney issues or significant ligament tears. Participants should also agree to use birth control during the study.Check my eligibility
What is being tested?
The trial is testing mesenchymal stem cell therapy from bone marrow against corticosteroids for treating knee osteoarthritis in a double-blinded setup across three US sites. It measures pain relief and joint function improvements through WOMAC scores, VAS pain scores, and MRI scans in 120 patients.See study design
What are the potential side effects?
Potential side effects may include discomfort at the injection site, allergic reactions to materials used in treatment (though rare), infection risk increase due to injections into the joint space, temporary swelling or stiffness of the treated knee.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My knee X-rays show I have moderate to severe arthritis.
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I am healthy, do not smoke, and can be either male or female.
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My heart rate, blood pressure, and lab tests are all within normal ranges.
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My weight is over 45 kg and my BMI is between 18 and 40.
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I am between 18 and 80 years old with knee osteoarthritis.
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My knee X-rays show arthritis severity of moderate to severe in one knee.
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My recent health checks, including heart tests, show no significant issues.
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My weight is over 45 kg and my BMI is between 18 and 40.
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My pain and joint function scores are high enough for the study.
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I am healthy, do not smoke, and can be either male or female.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 12 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change from Baseline Visual Analog Score (VAS) at 12 months
Change from Baseline Visual Analog Score (VAS) at 3 months
Change from Baseline Visual Analog Score (VAS) at 6 months
+4 moreSecondary outcome measures
Change from baseline measure of Fall Risk Functional Testing at 12 months
Change from baseline measure of Fall Risk Functional Testing at 3 months
Change from baseline measure of Fall Risk Functional Testing at 6 months
+9 moreSide effects data
From 2022 Phase 3 trial • 475 Patients • NCT0381873726%
Arthralgia
24%
Joint swelling
7%
Joint stiffness
1%
Myocardial infarction
1%
Renal neoplasm
1%
Tendon rupture
1%
Partial seizures
100%
80%
60%
40%
20%
0%
Study treatment Arm
Umbilical Cord Tissue (UCT) MSCs
Corticosteroid Injection
Bone Marrow Derived MSCs
Adipose-derived MSCs
Trial Design
4Treatment groups
Experimental Treatment
Active Control
Group I: Subchondral injection with Bone Marrow Derived MSCsExperimental Treatment2 Interventions
Participants will undergo a bone marrow aspirate procedure. Participants will receive a single subchondral injection of NGRM-001 on treatment day.
Group II: Intra-articular injection with Bone Marrow Derived Mesenchymal Stem Cells (MSCs)Experimental Treatment2 Interventions
Participants will undergo a bone marrow aspirate procedure. Participants will receive a single intra-articular injection of NGRM-001 on treatment day.
Group III: Combined Intra-articular and Subchondral injection with Bone Marrow Derived MSCsExperimental Treatment2 Interventions
Participants will undergo a bone marrow aspirate procedure. Participants will receive a single combined intra-articular and subchondral injection of NGRM-001 on treatment day.
Group IV: Corticosteroid injectionActive Control2 Interventions
Subjects in the corticosteroid group will undergo a mock bone marrow aspirate procedure. Participants will receive a single intra-articular injection of corticosteroid on treatment day.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Bone Marrow Derived MSCs
2019
Completed Phase 3
~480
Bone Marrow Aspirate
2015
Completed Phase 3
~40
Find a Location
Who is running the clinical trial?
Next Generation Regenerative Medicine LLCLead Sponsor
Michael A Scarpone, D.O.Principal InvestigatorNext Generation Regenerative Medicine LLC
James G UnnerstallStudy DirectorNext Generation Regenerative Medicine LLC
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I had a low-grade cancer (like breast cancer) over 3 years ago and it was treated successfully.My BMI is between 18 and 40.I am currently undergoing chemotherapy or radiation therapy.My knee X-rays show I have moderate to severe arthritis.I am healthy, do not smoke, and can be either male or female.My heart rate, blood pressure, and lab tests are all within normal ranges.My knee joint is misaligned by more than 1mm or has a bend greater than 9°.I had a knee injection within 6 weeks before my bone marrow aspirate injection.I agree to use birth control or avoid sex from one week before until three months after starting treatment.I do not have a fever, active infection, or ongoing infectious diseases like HIV or hepatitis.My weight is over 45 kg and my BMI is between 18 and 40.I have a severe bone condition like osteoporosis or Paget's disease.I've tried standard treatments for over 3 months without success or couldn't tolerate them.I have tried at least two non-surgical treatments without success.I am between 18 and 80 years old with knee osteoarthritis.I am taking medication for rheumatism, including methotrexate.I had a low-grade cancer (like breast cancer) over 3 years ago and it was treated successfully.My knee X-rays show arthritis severity of moderate to severe in one knee.I have not taken steroids by mouth, IV, or muscle shot in the last 6 weeks.I have not had severe anemia or bleeding disorders.I have severe blood flow problems, leg clots, heart issues, or major knee and walking problems.My recent health checks, including heart tests, show no significant issues.I am between 18 and 80 years old with knee osteoarthritis.My knee ligaments are not significantly torn or loose.I agree to use birth control or avoid sex from one week before until three months after starting treatment.I have had knee pain and trouble moving for over a month despite treatments like physical therapy and injections.I have a history of calcium crystal buildup in my joints.I am not pregnant or breastfeeding and will use birth control for 90 days after treatment.My weight is over 45 kg and my BMI is between 18 and 40.I am currently taking medication to prevent blood clots or for heart health.I am willing to stop taking pain medication 2 weeks before and during clinical assessments.My pain and joint function scores are high enough for the study.I have not had injections in my joints for pain or other treatments in the last 3 months.I do not have a major tear in my knee cartilage.I have conditions like claudication, varicose veins, or nerve issues affecting my walking.I do not have an active cancer or a history of cancer within the last 5 years.I am healthy, do not smoke, and can be either male or female.You are willing and able to provide written informed consent.I have diabetes, heart, liver, or kidney issues but they are under control.I do not have a Baker's cyst behind my knee.
Research Study Groups:
This trial has the following groups:- Group 1: Combined Intra-articular and Subchondral injection with Bone Marrow Derived MSCs
- Group 2: Intra-articular injection with Bone Marrow Derived Mesenchymal Stem Cells (MSCs)
- Group 3: Subchondral injection with Bone Marrow Derived MSCs
- Group 4: Corticosteroid injection
Awards:
This trial has 3 awards, including:- Approved for 10 Other Conditions - This treatment demonstrated efficacy for 10 other conditions.
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- All Individual Drugs Already Approved - Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What are the primary objectives of this research?
"The primary goal of this study, to be completed over the course of 3 months, is to Change from Baseline Visual Analog Score (VAS) at 12 months. Additionally, researchers will also measure the Change from baseline measure of Frailty Functional Testing at 12 months, defined as Frailty Functional Testing; the change from baseline measure of Fall Risk Functional Testing at 12 months, defined as Fall Risk Functional Testing; and finally, the change from baseline measure of Fall Risk Functional Testing at 6 months, once again defined as Fall Risk Functional Testing."
Answered by AI
Does this research project restrict participation to senior citizens?
"The ages of patients that this clinical trial can enroll range from 18 to 80 years old. In contrast, there are 39 other trials for minors and 691 research studies available for seniors."
Answered by AI
Are there any available positions for participants in this clinical trial?
"According to the latest information on clinicaltrials.gov, this trial is not currently seeking patients for participation. The trial was initially posted on 8/1/2022 and was most recently edited on 3/10/2022. There are 728 other studies actively enrolling participants at this time."
Answered by AI
Who meets the qualifications to participate in this research project?
"Osteoarthritis sufferers who are aged 18 to 80 and have issues with their knees may be eligible for this clinical trial, of which the team is looking for around 120 individuals."
Answered by AI
Who else is applying?
What state do they live in?
Tennessee
Other
Florida
Pennsylvania
How old are they?
18 - 65
65+
What site did they apply to?
Bluetail Medical Group
Scarpone Sports Regenerative
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
How many prior treatments have patients received?
3+
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