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Current list of patient funded clinical studies we are investigating.

Safety and Effectiveness of Autologous Stromal Vascular Fraction on Pain and
Inflammation associated with Osteoarthritis


Principal Investigator: Michael Geraci, MD, Dr. Romanth Waghmarae, MD

Study Design:

This is a prospective non-randomized clinical study of 30 patients to determine safety and treatment potential of autologous cell therapy for pain and inflammation associated with Osteoarthritis.

Patients will be treated for Osteoarthritis due to degeneration or chronic injury. They will be treated with autologous Stromal Vascular Fraction and Platelet Rich Plasma (PRP) as direct injections to the effected joints. Patient outcomes will be tracked with laboratory tests for inflammation markers, WOMAC questionnaires and a follow up MRI at various endpoints to
2 years.

Inclusion Criteria to be an eligable participant:

1. Patients with indication of Osteoarthritis. Can be from degeneration or chronic injury.
2. Or diabetes.
3. Patients range from 15-90 years of age.
4. Female patients not pregnant or lactating.
5. Patients with a history of or current corticosteroid therapy will only be eligible if use is
    suspended from 1 month prior to cell therapy.
6. Patients must be able to comply with treatment plan, laboratory tests and periodic
     interviews.
7. Patients with adequate renal function, creatine ≤ 1.5 mg/dl.
8. Patients with adequate blood coagulation activity, PT(INR) < 1.5, APTT <1.5×control.

Exclusion Criteria which will exclude you as a participant:

1. Diagnosis of cancer within 5 years prior to screening, except for cutaneous basal cell or
    squamous cell cancer resolved by excision.
2. Signs and symptoms of clinically significant cardiac disease or diabetes.
3. Diagnosis of a transient ischemic attack in the 6 months prior to screening.
4. Patients infected with hepatitis B, C or HIV.
5. Patients with Body Mass Index (BMI) > 35kg/m2
6. Any other illness that in the opinion of the investigator would render a patient unsuitable
    to participate in the study.

Aim

To purpose of this study is to quantifiably determine if the proposed protocol: an inter-articular injection with a combination of SVF, and PRP has a significant clinical effect on pain and inflammation associated with Osteoarthritis. Also by obtaining MRIs at 0, 6, 12, and 24 months, we hope to see regrowth of hyaline cartilage, for example on the femoral and tibial sides of the knee as well as posterior surface of the patella. Also the possibility of regrowth of meniscal tissue (fibrocartilage).

Rational

Despite considerable effort, successful treatment of degenerative osteoarthritis remains a difficult therapeutic challenge. We have seen evidence that SVF, and/or PRP are/is capable of exhibiting significant anti-inflammatory effects which may subsequently provide some relief from the pain associated with Osteoarthritis. We intend to examine whether direct injections of a combination SVF and PRP is a safe and effective treatment option to improve clinical care of degenerative osteoarthritis.

Background

Osteoarthritis is a joint inflammation that results from cartilage degeneration. It can be caused by aging, heredity, and injury from trauma or disease. Osteoarthritis is the most prevalent form of arthritis in the United States, affecting over 20 million adults. In fact, more than half of all people age 65 and over have evidence of osteoarthritis.The most common symptom of osteoarthritis is pain in the affected joint(s) after repetitive use. There is also evidence that raised systemic inflammatory markers have a role in future joint damage. Higher C-reactive protein (CRP) levels (indicative of inflammation) modestly but significantly predict those whose disease will progress. There is no blood test for the diagnosis of osteoarthritis. The goal of treatment in osteoarthritis is to reduce joint pain while improving and maintaining joint function.

Current Standard of Care

The cartilage is a unique avascular, aneural tissue that has limited capacity of self-repair once damaged. Despite ongoing research, treatments to manage the disease remain symptomatic. Treatment generally involves a combination of lifestyle modification, analgesics, non-steroidal anti-inflammatories, and joint injections with steroids or hyaluronic acid (lubricant). If pain becomes debilitating, joint replacement surgery may be used to improve the quality of life, e.g. partial joint resurfacing (hip and shoulder), and total joint replacement (hip and knee) The use of autologous SVF derived from adipose tissue as a treatment option has been rapidly gaining momentum. There are now a significant number of clinical trials listed on clinicaltrials.gov and ongoing IRCM IRB approved studies that support many variations of these therapies. We propose that the combined use of autologous SVF, and PRP will deliver significant benefits in the treatment of osteoarthritis.

Patient fees

Patients will pay a fee for treatment that is within the normal range of comparative treatments worldwide. This will cover all costs including, physicians and nursing staff, surgery center fees. Routine screening and blood work will be paid for by patient, however, no fees will be charged to the patient for additional lab work directly related to the study.

Possible side effects

Besides soreness from the liposuction procedure, and at the site of injection, there have been very few adverse effects reported with autologous therapies. Most likely there will be some aggravated inflammation or the effected joint, but that should be temporary. Occasionally, the patient will experience tiredness, and less frequently symptoms of detoxification such as low-grade fever, mild headache, or body aches. These will most likely occur within the first 24 hours after treatment. For that reason, the clinic will follow up by phone the following day, and if the patient is not local, they will be asked stay overnight and return to the clinic to be seen by the doctor before leaving town if there are any, even mild, adverse reactions.

Adverse Event Reporting

Clinic will be entering each patient into a Registry and will follow IRCM protocol dealing with reporting of adverse events. Adverse events will be classified as mild, moderate, or serious, and will be initially assessed by the Principal Investigator as being: not likely, somewhat likely, or likely related to the treatment, and if it was procedure or SVF related. In the event of a serious adverse event the IRB shall be notified immediately.

Follow up and review

2 month regular follow up and additional injection of PRP, regular follow up at 6 months, 1 year and 2 years. MRI will be done pre procedure, 6 month, 1 year and 2 year to see if there has been any noticeable change. Also patients will fill out a WOMAC questionnaire at 6 months, 1 year and 2 year to find out if the patient has had improvements in their quality of life.

Patient Confidentiality

Patient identifying information will be kept confidential. Outcome measures with will be shared with the IRB for review and must be made available for audit any time during or after the study.

Withdrawals

Participation in the study is voluntary and patients may withdraw at any time. Patients who withdraw prematurely will not be replaced, but investigators will determine if it is in the best interest of the study to extend the study in order to obtain the desired number of subjects. An inquiry will be made as to the reason for termination and an assessment of the patient’s well being at the time. If the termination is the result of an adverse event this will be reported.

End Point


At the end of 2 years from time of treatment a final interview will be made with the patient to assess his or her overall experience. This will be included with the data and final evaluation to determine the safety and level of efficacy of this method in the treatment of pain and inflammation associated with Osteoarthritis.

References

1. http://www.cdc.gov/arthritis
2. http://www.healingwell.com/library/arthritis/info3.asp
3. Moskowitz RW, Holderbaum D. Clinical and laboratory findings in osteoarthritis.
    In: Arthritis and Allied Conditions, Koopman WJ, Williams & Wilkins, Baltimore 2001. p.221.
4. J Rheumatol. 1997 Jun;24(6):1164-7. Risk factors for osteoarthritis in the tibiofemoral and
    patellofemoral joints of the knee. Cicuttini FM, Spector T, Baker J.
5. William C. Shiel Jr., MD, http://www.medicinenet.com/osteoarthritis/article.htm
6. Black LL, Gaynor J, Gahring D, Adams C, Aron D, Harman S, et al. Effect of adipose-derived
    mesenchymal stem and regenerative cells on lameness in dogs with chronic osteoarthritis     of the coxofemoral joints: a randomized, double-blinded, multicenter, controlled trial. Vet     Ther. 2007;8(4):272-84.
7. Karussis D, Kassis I. The potential use of stem cells in multiple sclerosis: an overview of the     preclinical experience. Clin Neurol Neurosurg. 2008;110(9):889-96.
8. Riordan NH, Ichim TE, Min WP, Wang H, Solano F, Lara F, et al. Non-expanded adipose     stromal vascular fraction cell therapy for multiple sclerosis. J Transl Med. 2009;7:29. PMCID:     2679713.
9. Applications of Mesenchymal Stem Cells in Cartilage Tissue Engineering. Ali Mobasheri,     Mehdi Shakibaei, Musculoskeletal Research Group, Institute of Anatomy, Ludwig-     Maximilian-University Munich, Germany. November 13, 2010.



Safety and Efficacy of Intradiscal Autologous Stromal Vascular Fraction


Principal Investigator: Dr. Romanth Waghmarae, MD

Study Design:


This is a prospective non-randomized clinical study of 20 patients to determine safety and treatment potential of autologous cell therapy for patients suffering from Disk Disease.

20 Patients who present with leg and/or back pain and have failed traditional therapy for hyperintense zones, bulges, herniations, and disc height issues will be enrolled, and treated intradiscally with autologous Stromal Vascular Fraction mixed with Platelet Rich Plasma (PRP). Patient outcomes will be tracked with QOL questionnaires and follow up MRIs at various endpoints to 2 years.

Inclusion Criteria to be an eligable participant:

1. Subjects with confirmed evidence of disk disease and pain rating 6/10-9/10. L4-5, L5-S1
    or additional lumbar areas.
2. Subjects range from 25-60 years of age.
3. Subject must have sufficient fat for liposuction.
4. Subjects must have adequate renal function in the opinion of the investigator.
5. Subjects must have adequate cardiovascular function in the opinion of the investigator.
6. Subjects must be able to comply with treatment plan, imaging and questionnaires.
7. Previous surgical evaluation or pending surgery is carefully noted.
8. Subject must be able to consent.

Exclusion Criteria which will exclude you as a participant:

1. Diagnosis of cancer malignancies within 5 years prior to screening, except for cutaneous
    basal cell or squamous cell cancer resolved by excision.
2. Subjects infected with HIV.
3. Pregnant or lactating subjects.
4. Subjects with BMI >35
5. Subjects presenting with stenosis, spondylosis, facet disease, or foraminal pathology
6. Any other illness that in the opinion of the investigator would render a subject unsuitable
    to participate in the study.

Aim

To purpose of this study is to quantifiably determine if the proposed protocol: Safety and Efficacy of Intradiscal Autologous Stromal Vascular Fraction; an intradiscal injection with a combination of SVF, and PRP, has a significant clinical effect disk pain from hyperintense zones, bulges, herniations, and disc height issues. Additionally, if it has any effect on the
rate of subsequent surgical procedures.

Patient fees

Patients will pay a fee for treatment that is within the normal range of comparative treatments worldwide. This will cover all costs including, physicians and nursing staff, surgery center fees. Routine screening and blood work will be paid for by patient, however, no fees will be charged to the patient for additional lab work directly related to the study.

Possible side effects

Besides soreness from the liposuction procedure, and at the site of injection, there have been very few adverse effects reported with autologous therapies. Most likely there will be some aggravated inflammation or the effected joint, but that should be temporary. Occasionally, the patient will experience tiredness, and less frequently symptoms of detoxification such as low-grade fever, mild headache, or body aches. These will most likely occur within the first 24 hours after treatment. For that reason, the clinic will follow up by phone the following day, and if the patient is not local, they will be asked stay overnight and return to the clinic to be seen by the doctor before leaving town if there are any, even mild, adverse reactions.

Adverse Event Reporting

Clinic will be entering each patient into a Registry and will follow IRCM protocol dealing with reporting of adverse events. Adverse events will be classified as mild, moderate, or serious, and will be initially assessed by the Principal Investigator as being: not likely, somewhat likely, or likely related to the treatment, and if it was procedure or SVF related. In the event of a serious adverse event the IRB shall be notified immediately.

Follow up and review

2 month regular follow up and additional injection of PRP, regular follow up at 6 months, 1 year and 2 years. MRI will be done pre procedure, 6 month, 1 year and 2 year to see if there has been any noticeable change. Also patients will fill out VAS scale and a SF 36 questionnaire at 6 months, 1 year and 2 year to find out if the patient has had improvements in their quality of life.

Patient Confidentiality

Patient identifying information will be kept confidential. Outcome measures with will be shared with the IRB for review and must be made available for audit any time during or after the study.

Withdrawals

Participation in the study is voluntary and patients may withdraw at any time. Patients who withdraw prematurely will not be replaced, but investigators will determine if it is in the best interest of the study to extend the study in order to obtain the desired number of subjects. An inquiry will be made as to the reason for termination and an assessment of the patient’s well being at the time. If the termination is the result of an adverse event this will be reported.

End Point


At the end of 2 years from time of treatment a final interview will be made with the patient to assess his or her overall experience. This will be included with the data and final evaluation to determine the safety and level of efficacy of this method in the treatment of disc pain.

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