List of Current, Clinical Trials for Regenexx Procedures for Orthopedic Conditions

Claire

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http://www.regenexx.com/regenexx-clinical-research-studies/

Regenexx ACL Stem Cell Procedure Study
ACL Study Criteria Patient Requirements

The patient must be willing to come to the Broomfield clinic for first an initial evaluation to make a final determination of study eligibility (includes diagnostic ultrasound)
There is no guarantee they will be eligible
The cost of this evaluation will be billed to the patient and/or their insurance
If eligible, the patient must be willing to return for treatment at the Broomfield clinic and for all post-injection treatments (6 weeks, 3 months, 6 months, 12 months, 24 months)
Costs of any travel will be the responsibility of the patient
The patient will be randomized to receive either Regenexx-SD treatment or be instructed in a home exercise therapy program
Patients in the exercise therapy group will have the opportunity to receive a Regenexx SD treatment after the three month visit if they do not respond to the exercise therapy
The Regenexx SD treatment will be provided at no cost to the patient
The patient must have a knee MRI current within the last year at their own cost for study screening purposes.
The subject must meet all inclusion criteria and not meet any exclusion criteria (complete list below). Key criteria include:
Age 18-65
can comply with all post-operative evaluations and visits
No previous surgery to the affected ACL
MCL, PCL or LCL tears of same knee
Meniscus or cartilage injury at same time as ACL that is painful
Current or past malignancy (cancer)

Inclusion Criteria

Candidates must meet ALL of the following:

1) Voluntary signature of the IRB approved Informed Consent,

2) Skeletally mature Male or Female ages 18 to 65

3) Pain, swelling, or functional disability in the affected knee with activity, having failed conservative treatment (e.g. NSAIDs, physician initiated physical therapy) for at least 3 months or unable to return to normal day to day activities by 6 weeks

4) Physical examination consistent with lax ACL ligament (Anterior Drawer Test)

5) Abnormal Telos Arthrometer measurement

6) Positive diagnostic MR imaging of the affected knee with at least 1/3 of the ACL ligament at any area along its length having high signal on MRI PDFS/Fat Sat images.

7) Full range of motion of the affected knee (other than restriction clearly due to effusion)

8) Normal range of motion of the non-treated knee

9) Is independent, ambulatory, and can comply with all post-operative evaluations and visits
Exclusion Criteria

Candidates will be excluded if they meet ANY of the following:

1) A massive ACL tear or one that includes more than 2/3’rds of the ligament that’s retracted.

2) Previous surgery to the affected ACL (i.e. previous ACL replacement with an autograft or allograft)

3) Prior ACL prolotherapy, PRP, corticosteroid injection or other injection therapy within the past three months,

4) Concomitant meniscus tear or cartilage injury that occurred at the same time as the as the ACL tear and which is considered a pain generator by the treating physician at the time intake into the study (i.e. a meniscus tear or cartilage lesion associated with an active BML).

5) Concomitant PCL, MCL, or LCL tears

6) Inflammatory or auto-immune based joint diseases or other lower extremity pathology (e.g., rheumatoid arthritis, systemic lupus erythematosus, psoriatic arthritis, polymyalgia, polymyositis, gout pseudogout)

7) Quinolone or Statin induced myopathy/ tendinopathy

8) Kellgren-Lawrence grade 2 or greater knee osteoarthritis

9) Significant knee extension lag compared to the opposite knee

10) Symptomatic lumbar spine pathology (e.g. radicular pain)

11) Severe neurogenic inflammation of the cutaneous nerves about the knee or thigh

12) Contraindications for MRI

13) Tested positive or has been treated for a malignancy in the past or is suspected of having a malignancy or is currently undergoing radiation or chemotherapy treatment for a malignancy anywhere in the body, whether adjacent to or distant from the proposed injection site

14) Condition represents a worker’s compensation case

15) Currently involved in a health-related litigation procedure

16) Is pregnant

17) Bleeding disorders

18) Currently taking anticoagulant or immunosuppressive medication

19) Allergy or intolerance to study medication

20) Use of chronic opioid,

21) Documented history of drug abuse within six months of treatment

22) Any other condition, that in the opinion of the investigator, that would preclude the patient from enrollment


Regenexx PL-Disc Study for Back / Spine
PL-Disc Study Patient Requirements


The patient must be willing to come to the Broomfield clinic for first an initial evaluation to make a final determination of study eligibility (includes diagnostic ultrasound)
There is no guarantee they will be eligible
The cost of this evaluation will be billed to the patient and/or their insurance
If eligible, the patient must be willing to return for treatment at the Broomfield clinic and for all post-injection treatments (6 weeks, 3 months, 6 months, 12 months)
Costs of any travel will be the responsibility of the patient
The patient will be randomized to receive either Regenexx PL-Disc treatment or Steroid Epidural. The patient will be blinded to the treatment they receive.
Patients in the Steroid Epidural group will have the opportunity to receive a Regenexx PL-Disc treatment after the three month visit if they do not respond to the Steroid Epidural
The Regenexx PL-Disc treatment will be provided at no cost to the patient
The patient must have a spine MRI current within the last year at their own cost for study screening purposes.
The subject must meet all inclusion criteria and not meet any exclusion criteria (complete list below). Key criteria include:
Age 18-65
Pain, spasm, or functional disability in the low back and diagnosed as radiculopathy
can comply with all post-operative evaluations and visits
Previous low back surgery
Prior epidural steroid injection or other low back injection therapy within the past year (if this is the only criteria excluding the patient, place on a list to contact when they reach 1 year)
Current or past malignancy (cancer)

Inclusion Criteria

Candidates must meet ALL of the following:

1) Voluntary signature of the IRB approved Informed Consent,

2) Skeletally mature Male or Female ages 18 to 65

3) Pain, spasm, or functional disability in the low back and diagnosed as radiculopathy having failed conservative treatment (e.g. NSAIDs, physician initiated physical therapy) for at least 3 months and not longer than 2 years

4) Significant functional disability related to pain, lack of strength, or other back or leg symptoms

5) Physical examination consistent with lumbar radiculopathy

6) Lumbar disc bulge, herniation, and/or Kader grade 2 or greater multifidus atrophy evident on MRI and consistent with physical exam findings

7) Is independent, ambulatory, and can comply with all post-operative evaluations and visits
Exclusion Criteria

Candidates will be excluded if they meet ANY of the following:

1) Symptomatic central or foraminal stenosis

2) Previous low back surgery

3) Prior epidural steroid injection or other low back injection therapy within the past year

4) >50% loss of disc height at the symptomatic level

5) Spondylolisthesis

6) Inflammatory or auto-immune based pathology (e.g., rheumatoid arthritis, systemic lupus erythematosus, psoriatic arthritis, polymyalgia, polymyositis, gout pseudogout)

7) Quinolone or Statin induced myopathy/tendinopathy

8) Severe neurogenic inflammation of the cutaneous nerves

9) Condition represents a worker’s compensation case

10) Currently involved in a health-related litigation procedure

11) Is pregnant

12) Bleeding disorders

13) Currently taking anticoagulant or immunosuppressive medication

14) Allergy or intolerance to study medication

15) Use of chronic opioid,

16) Documented history of drug abuse within six months of treatment

17) Any other condition, that in the opinion of the investigator, that would preclude the patient from enrollment

Regenexx Rotator Cuff Stem Cell Procedure Study
Shoulder Rotator Cuff Study Patient Requirements

The patient must be willing to come to the Broomfield clinic for first an initial evaluation to make a final determination of study eligibility (includes diagnostic ultrasound)
There is no guarantee they will be eligible
The cost of this evaluation will be billed to the patient and/or their insurance
If eligible, the patient must be willing to return for treatment at the Broomfield clinic and for all post-injection treatments (6 weeks, 3 months, 6 months, 12 months, 24 months)
Costs of any travel will be the responsibility of the patient
The patient will be randomized to receive either Regenexx-SD treatment or be instructed in a home exercise therapy program
Patients in the exercise therapy group will have the opportunity to receive a Regenexx SD treatment after the three month visit if they do not respond to the exercise therapy
The Regenexx SD treatment will be provided at no cost to the patient
The patient must have a shoulder MRI current within the last year at their own cost for study screening purposes.
The subject must meet all inclusion criteria and not meet any exclusion criteria (complete list below). Key criteria include:
Age 18-65
can comply with all post-operative evaluations and visits
No previous surgery to the affected shoulder
Current or past malignancy (cancer)

Inclusion Criteria

Candidates must meet ALL of the following:

Voluntary signature of the IRB approved Informed Consent,
Skeletally mature Male or Female ages 18 to 65
Unremitting pain in the affected shoulder having failed conservative treatment (e.g. NSAIDs, physician initiated physical therapy or a corticosteroid injection) for at least 3 months
Significant functional disability related to pain, lack of strength, or other shoulder symptoms
Physical examination consistent with Rotator Cuff tear
Positive diagnostic imaging, which may include arthrogram, ultrasound and/or MR, on the affected shoulder indicating a non-retracted supraspinatus tendon tear comprising at least one half the tendon thickness in the anterior-posterior and/or superior-inferior planes
Reasonable movement of the non-treated arm, defined as a shoulder elevation of equal or more than 90°, and able to perform (post-injection) exercises
Is independent, ambulatory, and can comply with all post-operative evaluations and visits

Exclusion Criteria

Candidates will be excluded if they meet ANY of the following:

A massive rotator cuff tear as demonstrated by Grade 3 or less muscle strength on testing internal and external rotation of the affected shoulder
Previous surgery to the affected shoulder
Prior rotator cuff prolotherapy, PRP or other RC injection-based therapies within the past three months,
Concomitant tears of multiple rotator cuff or biceps tendons
Grade 2 or greater SLAP tear
Type 3 acromion
Significant bone spur in subacromial space
Inflammatory or auto-immune based joint diseases or other upper extremity pathology (e.g., rheumatoid arthritis, systemic lupus erythematosus, psoriatic arthritis, polymyalgia, polymyositis, gout pseudogout)
Quinolone or Statin induced myopathy/ tendinopathy
Kellgren-Lawrence grade 2 or greater glenohumeral osteoarthritis
Adhesive capsulitis (mild or severe)
Symptomatic cervical spine pathology (e.g. radicular cervical pain)
Severe neurogenic inflammation of the cutaneous nerves about the shoulder
Shoulder instability requiring surgical stabilization
Contraindications for MRI
Tested positive or has been treated for a malignancy in the past or is suspected of having a malignancy or is currently undergoing radiation or chemotherapy treatment for a malignancy anywhere in the body, whether adjacent to or distant from the proposed injection site
Condition represents a worker’s compensation case
Currently involved in a health-related litigation procedure
Is pregnant
Bleeding disorders
Currently taking anticoagulant or immunosuppressive medication
Allergy or intolerance to study medication
Use of chronic opioid,
Documented history of drug abuse within six months of treatment
Any other condition, that in the opinion of the investigator, that would preclude the patient from enrollment


Chicago Knee Osteoarthritis Study – Mitchell Sheinkop

You must currently reside within driving distance of the Chicago, Illinois area to be considered for this study due to regularly scheduled follow-ups.

Regenexx is currently seeking candidates for a knee osteoarthritis study that is taking place in Chicago, Illinois. Additional information is provided below. Complete details on the study can be found at the clinicaltrials.gov website.
 
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