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Regenerative Medicine: Stem Cell Injections & PRP Therapy

This page contains a wealth of information about our regenerative medicine treatment options, which include stem cell injections and Plasma Rich Platelets (PRP) Treatments. Click the buttons below to scroll directly to the related content.
LEARN MORE ABOUT STEM CELL INJECTIONSLEARN MORE ABOUT PRP THERAPY

STEM CELL INJECTIONS


 

What are Stem Cells?

Stem Cells are cells in your body which have the ability to turn into other types of cells. These are specialized cells that trigger a repair response and replace damaged tissues. There are different types of Stem Cells, but for musculoskeletal injuries and low back pain, the only one with demonstrated efficacy is the mesenchymal stem cells (MSC).  These cells secrete growth factors and chemicals that have anti-inflammatory properties. They not only reduce pain, but also repair or replace damaged tissue.

Are Stem Cell procedures ethical?

Yes, they are absolutely ethical! We follow FDA regulations and guidelines. We are using your own cells to treat and repair the joints and spine. Hence no issue!

FDA has strict guidelines regarding utilization of Stem Cell products in patients. We only use FDA approved products. When Stem Cell products are used in unapproved ways or when the nature and degree of processing is more than minimally manipulated, it becomes an issue.

For further information on rules and regulations, please visit the FDA CFR – Code of Federal Regulations Title 21

We do not use cord blood or amniotic tissue Stem Cells as they are not FDA approved.

Simply speaking, the way we use your Stem Cells to treat your pain, there are no controversies or ethical issues.

Is the Procedure Effective?

Clinical trials have demonstrated efficacy of Stem Cell injections for lower back and musculoskeletal pain. Most patients have shown 70+% improvement in their pain and function.

Is it FDA approved?

Yes!

The Stem Cell Treatment we use has been cleared by the FDA. We follow FDA guidelines and Protocols

[CITE: 21CFR1271.10]

CASE STUDY: Assessing the safety and feasibility of intradiscal bone marrow concentrate (BMC) injections to treat discogenic pain as an alternative to surgery.

Treatment of discogenic back pain with autologous bone marrow concentrate injection with minimum two year follow-up.

Abstract

PURPOSE:

The purpose of this study is to assess safety and feasibility of intradiscal bone marrow concentrate (BMC) injections to treat discogenic pain as an alternative to surgery.

METHODS:

A total of 26 patients (11 male, 15 female, aged 18-61 years, 13 single level, 13 two level) that met inclusion criteria of chronic (> 6 months) discogenic low back pain, degenerative disc pathology assessed by magnetic resonance imaging (MRI) with modified Pfirrmann grade of IV-VII at one or two levels, candidate for surgical intervention (failed conservative treatment and radiologic findings) and a visual analogue scale (VAS) pain score of 40 mm or more at initial visit. Initial Oswestry Disability Index (ODI) and VAS pain score average was 56.5 % and 80.1 mm (0-100), respectively. Adverse event reporting, ODI score, VAS pain score, MRI radiographic changes, progression to surgery and cellular analysis of BMC were noted. Retrospective cell analysis by flow cytometry and colony forming unit-fibroblast (CFU-F) assays were performed to characterise each patient’s BMC and compare with clinical outcomes. The BMC was injected into the nucleus pulposus of the symptomatic disc(s) under fluoroscopic guidance. Patients were evaluated clinically prior to treatment and at three, six, 12 and 24 months and radiographically prior to treatment and at 12 months.

RESULTS:

There were no complications from the percutaneous bone marrow aspiration or disc injection. Of 26 patients, 24 (92 %) avoided surgery through 12 months, while 21 (81 %) avoided surgery through two years. Of the 21 surviving patients, the average ODI and VAS scores were reduced to 19.9 and 27.0 at three months and sustained to 18.3 and 22.9 at 24 months, respectively (p ≤ 0.001). Twenty patients had follow-up MRI at 12 months, of whom eight had improved by at least one Pfirrmann grade, while none of the discs worsened. Total and rate of pain reduction were linked to mesenchymal stem cell concentration through 12 months. Only five of the 26 patients elected to undergo surgical intervention (fusion or artificial disc replacement) by the two year milestone.

CONCLUSIONS:

This study provides evidence of safety and feasibility in the non-surgical treatment of discogenic pain with autologous BMC, with durable pain relief (71 % VAS reduction) and ODI improvements (> 64 %) through two years.

SEE FULL ORIGINAL CASE STUDY

CASE STUDY: Intervertebral disc repair by autologous mesenchymal bone marrow cells

Intervertebral disc repair by autologous mesenchymal bone marrow cells: a pilot study.

Abstract

BACKGROUND:

Degenerative disc disease may cause severe low-back pain, a large public health problem with significant economic and life quality impact. Chronic cases often require surgery, which may lead to biomechanical problems and accelerated degeneration of the adjacent segments. Cell-based therapies may circumvent these problems and have exhibited encouraging results in vitro and in animal studies. We designed a pilot study to assess feasibility and safety and to obtain early indications on efficacy of treatment with mesenchymal stem cells (MSC) in humans.

METHODS:

Ten patients with chronic back pain diagnosed with lumbar disc degeneration with intact annulus fibrosus were treated with autologous expanded bone marrow MSC injected into the nucleus pulposus area. Clinical evolution was followed for 1 year and included evaluation of back pain, disability, and quality of life. Magnetic resonance imaging measurements of disc height and fluid content were also performed.

RESULTS:

Feasibility and safety were confirmed and strong indications of clinical efficacy identified. Patients exhibited rapid improvement of pain and disability (85% of maximum in 3 months) that approached 71% of optimal efficacy. This outcome compares favorably with the results of other procedures such as spinal fusion or total disc replacement. Although disc height was not recovered, water content was significantly elevated at 12 months.

CONCLUSIONS:

MSC therapy may be a valid alternative treatment for chronic back pain caused by degenerative disc disease. Advantages over current gold standards include simpler and more conservative intervention without surgery, preservation of normal biomechanics, and same or better pain relief.

 

SEE FULL ORIGINAL CASE STUDY

CASE STUDY: A multi-center analysis among adult patients undergoing adult autologous stem cell therapy for orthopaedic conditions.

A multi-center analysis of adverse events among two thousand, three hundred and seventy two adult patients undergoing adult autologous stem cell therapy for orthopaedic conditions.

Erratum in

  • Correction to: A multi-center analysis of adverse events among two thousand, three hundred and seventy two adult patients undergoing adult autologous stem cell therapy for orthopaedic conditions. [Int Orthop. 2018]

Abstract

INTRODUCTION:

The purpose of the present investigation is to report on detailed complications among a much larger group of 2372orthopaedic patients treated with stem cell injections who were followed in a treatment registry for up to nine years.

METHODS:

All patients underwent an MSC-based, percutaneous injection treatment of an orthopaedic condition between December 2005 and September 2014 at one of 18 clinical facilities. Treated areas of the body included the knee, hip, ankle/foot, hand/wrist, elbow, shoulder, and spine. The patients were followed prospectively via enrollment in a treatment registry. Patients were followed prospectively at one, three, six and 12 months, and annually thereafter, using an electronic system, ClinCapture software.

RESULTS:

A total of 3012 procedures were performed on 2372 patients with follow-up period of 2.2 years. A total of 325 adverse events were reported. The majority were pain post-procedure (n = 93, 3.9 % of the study population) and pain due to progressive degenerative joint disease (n = 90, 3.8 % of the study population). Seven cases reported neoplasms, a lower rate than in the general population. The lowest rate of adverse events was observed among patients injected with BMC alone.

CONCLUSION:

Lowest rate of adverse events was among those patients receiving BMC injections alone, but the higher rate of AEs for BMC plus adipose and cultured cells was readily explained by the nature of the therapy or the longer follow-up. There was no clinical evidence to suggest that treatment with MSCs of any type in this study increased the risk of neoplasm.

 

SEE FULL ORIGINAL CASE STUDY

How is the stem cell procedure performed?

This procedure is done in an office setting. It is a relatively painless procedure which requires local anesthesia and in some instances minimal sedation. Dr. Manocha performs this procedure with high quality techniques and precision to achieve the best results.

There are three parts to the procedure:

(1) The bone marrow aspiration (BMA)

(2) Isolation of Stem Cells from the BMA

(3) Reinjection of the Stem Cells in the target area

Dr. Manocha extracts 60 cc of Bone Marrow which contains Stem Cells, Platelets and key Cytokines. This BMA is then concentrated using a centrifuge to produce high quality bone marrow concentrate (BMC) that has the stem cells. He also creates high-dose Platelet Rich Plasma (PRP) from the bone marrow which is used along with the Stem Cells for treatment. This latter part (PRP) is important as it helps stimulate the Stem Cells.

Finally, after using ample amount of local anesthesia, the needles are placed in the target areas utilizing state of the art imaging guidance (fluoroscopy or ultrasound).  The solution containing the stem cells and platelets rich in growth factors and anti-inflammatory agents are reinjected.

The whole process takes about 1 to 2 hours depending on the areas being treated. The recovery period is minimal.

What happens after the procedure?

The procedure is performed under mild sedation and local anesthesia. As mentioned before, the procedure can take up to 1 to 2 hours depending on the areas being treated. It is an office based procedure and you go home the same day. Since sedation is provided, you are not allowed to drive or operate any hazardous devices for 24 hours after the procedure.

AVOID: Alcohol, caffeine, and cigarettes for 3 days after your treatment.

Limit lifting to 5 lbs. and avoid stooping and bending for at least 2 weeks. If knees or hip joints are treated, limit stairs unless absolutely necessary – and if needed, take them one at a time.

It is recommended that you do not to do any strenuous activity for a month however, we encourage maintaining activities of daily living. Following the procedure, one can expect to have some pain at the donor site (hip bone) where the stem cells are extracted. Depending on your threshold for pain, you will be provided with medication for discomfort that is appropriate for you. In most cases, non-narcotic pain medication like Tylenol is sufficient. However, if narcotic pain medication is needed, a small dose of Hydrocodone or Oxycodone will be prescribed. We do not recommend the use of Non-steroidal anti-inflammatory medications such as Motrin, Ibuprofen, Advil etc. for two weeks after the procedure as they interfere with the Stem Cell activation.

Am I a candidate for the procedure?

Dr. Manocha will do an initial consultation to determine if you are a candidate for Stem Cell treatment. During the initial consultation, your imaging studies (MRI/CT scan and/or X-ray) will be evaluated.

Patients that have any bleeding disorders, cancers, and bone marrow disorders are not ideal patients. There are other options available for these patients.

For back pain conditions, if you have severe stenosis on MRI or show dynamic spondylolisthesis on X-ray, you are not an ideal patient for the Stem Cell therapy.

If you have weakness in your leg/legs as a result of a nerve compression or if you have bowel or bladder incontinence due to spinal cord compression, you are not eligible for this procedure.

If you have disc degeneration along with arthritis of the facet joints and have failed to get adequate amounts of relief from the conservative therapy including injections, you may be a good candidate for Stem Cell therapy.

Orthopedic conditions including acute and chronic injuries of muscle, tendon, ligaments, bone, and cartilage can be treated with Stem Cell therapy. Some specific conditions that can be treated with stem cell therapy include:

  • Mild to moderate osteoarthritis/degenerative arthritis of joints, especially the hip and knee
  • Tendon injuries, including partial tears of the rotator cuff of the shoulder
  • Back pain related to degenerative disc and facet joint

What are the risks?

All medical treatments have benefits and risks. Having said that, there have been a number of studies looking at the potential complications from Stem Cell injections and they have not reported any major adverse events.

The potential risks are the same as with any procedure, which may also include:

  • Bleeding at the bone marrow aspiration site
  • Increased pain at the bone marrow aspiration site
  • Administration site reactions
  • Failure of cells to work as expected

Unproven Stem Cell Therapies (not following FDA guidelines) can be particularly unsafe.

In order to minimize the potential risks, it is very important to have this therapy done by an experienced physician with interventional skills.

Is this covered by insurances?

Unfortunately, this therapy is not covered under the insurance. Consultation is free for you. The Stem Cell treatment cost for Spine procedures is cheaper in some instances than the “out of pocket” expense in spite of having insurance. That said, Dr. Manocha offers the lowest prices in the area to make it affordable to you.

If you decide that it is not financially feasible for you to undergo the treatment, Dr. Manocha will discuss other alternative or traditional treatment options (covered by insurance). Depending on the diagnosis, you might be a candidate who would benefit from simple procedures such as nerve blocks, facet joint injections/ablations to complex procedures such as minimally invasive lumbar decompression (MILD) or spinal cord stimulation.

IT’S YOUR PAIN, CHOOSE THE RIGHT DOCTOR!!!!

PRP TREATMENT


 

What is PRP?

The initials PRP stand for Platelet Rich Plasma. 
 
As the name suggests, Platelet rich plasma is blood that contains a higher concentration of platelets than normal blood. Platelets, the component of blood best known for their importance in clotting, also contain hundreds of protein rich growth factors important in healing injuries. As “First Responder cells”, platelets help control the damage when we get injured, and start the healing process.
 

How does PRP Treatment Work?

Blood is first drawn from a patient.  The blood is placed in a centrifuge where the platelets are separated from the plasma. This allows for a much higher concentration of platelets, 5 to 10 times that of a normal blood sample.
The concentrated platelets are combined with a small amount of plasma to then be re-injected into the patient at the appropriate site.

Has PRP Therapy been approved by the FDA?

Yes!

We follow FDA guidelines and Protocols. [CITE: 21CFR640.34]

What conditions may be treated with PRP?

Research is currently ongoing that evaluates the effectiveness of PRP. Factors that may influence effectiveness include:
  • The area of the body being treated
  • Overall health of the patient
  • Whether the injury is acute (such as the result of a fall) or chronic (developed over time)
 
According to research, PRP is most effective in the treatment of chronic tendon injuries, but has shown effectiveness in relieving pain related to:
  • tennis elbow
  • Achilles tendonitis
  • Patellar tendon treatment
  • Acute ligament and muscle injury
  • Disc injuries of neck and lumbar spine
  • Low back pain

Risks of Injection and side effects:

All medical treatments have benefits and risks. Having said that, there have been a number of studies looking at the potential complications from PRP injections and they have not reported any major adverse events.

Published studies have found few if any side effects and suggest that PRP is safe and less invasive than many other options. Because it involves a person’s own blood, an allergic or other adverse reaction is less likely than with other injections.

Is this covered by insurances?

Unfortunately, this therapy is not covered under most insurances. Consultation is free for you. Dr. Manocha offers the lowest prices in the area to make it affordable to you.

If you decide that it is not financially feasible for you to undergo the treatment, Dr. Manocha will discuss other alternative or traditional treatment options (covered by insurance). Depending on the diagnosis, you might be a candidate who would benefit from simple procedures such as nerve blocks, facet joint injections/ablations to complex procedures such as minimally invasive lumbar decompression (MILD) or spinal cord stimulation.

IT’S YOUR PAIN, CHOOSE THE RIGHT DOCTOR!!!!

PRP Therapy Success Story!

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