← Back to Search

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.

Must not have

Subjects with a BMI of >40 and <18 will be excluded

Current chemo or radiation therapy

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 12 months

Awards & highlights

No Placebo-Only Group

All Individual Drugs Already Approved

Approved for 10 Other Conditions

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.

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.

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 below

Select...

My knee X-rays show I have moderate to severe arthritis.

Select...

I am healthy, do not smoke, and can be either male or female.

Select...

My heart rate, blood pressure, and lab tests are all within normal ranges.

Select...

My weight is over 45 kg and my BMI is between 18 and 40.

Select...

I am between 18 and 80 years old with knee osteoarthritis.

Select...

My knee X-rays show arthritis severity of moderate to severe in one knee.

Select...

My recent health checks, including heart tests, show no significant issues.

Select...

My weight is over 45 kg and my BMI is between 18 and 40.

Select...

My pain and joint function scores are high enough for the study.

Select...

I am healthy, do not smoke, and can be either male or female.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

My BMI is between 18 and 40.

Select...

I am currently undergoing chemotherapy or radiation therapy.

Select...

My knee joint is misaligned by more than 1mm or has a bend greater than 9°.

Select...

I do not have a fever, active infection, or ongoing infectious diseases like HIV or hepatitis.

Select...

I have a severe bone condition like osteoporosis or Paget's disease.

Select...

I have not taken steroids by mouth, IV, or muscle shot in the last 6 weeks.

Select...

I have not had severe anemia or bleeding disorders.

Select...

I have severe blood flow problems, leg clots, heart issues, or major knee and walking problems.

Select...

I have a history of calcium crystal buildup in my joints.

Select...

I am currently taking medication to prevent blood clots or for heart health.

Select...

I am willing to stop taking pain medication 2 weeks before and during clinical assessments.

Select...

I do not have an active cancer or a history of cancer within the last 5 years.

Select...

I have diabetes, heart, liver, or kidney issues but they are under control.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 12 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~12 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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 more

Secondary study objectives

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 more

Side effects data

From 2022 Phase 3 trial • 475 Patients • NCT03818737

26%

Procedural pain

25%

Arthralgia

18%

Joint swelling

12%

Joint stiffness

10%

Post procedural contusion

Post procedural haematoma

Migraine

Acute myocardial infarction

Angina pectoris

Cholecystitis

Nephrolithiasis

Invasive ductal breast carcinoma

Traumatic pneumothorax

Hypertension urgency

100%

80%

60%

40%

20%

Study treatment Arm

Bone Marrow Derived MSCs

Adipose-derived MSCs

Umbilical Cord Tissue (UCT) MSCs

Corticosteroid Injection

Awards & Highlights

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.

Approved for 10 Other Conditions

This treatment demonstrated efficacy for 10 other conditions.

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