Current Development of Cell-based Therapies in the United States

Current Development of Cell-based Therapies in the United States

Medical research advances enable physicians to find new and innovative ways to use the body’s systems to fight disease and injury.

Regenerative medicine is a field of medicine that uses the body’s own cells and tissues to heal injuries and medical conditions. In the treatment of cancer the cells are used in immunotherapy, which involves modifying patient’s cells to fight the disease. In the field of orthopedics, regenerative medicine specialists use the patient’s own blood cells, bone marrow or adipose tissue to help the body boost its own natural healing properties. These are known as orthobiologics.

At the present time, FDA allows the use of autologous orthobiologics —which means the tissue or cells used must come from the same patient. Donor  products are not allowed to be used in clinical setting unless it is used under the purview of a clinical trial. Read here on the FDA guidance on the use of human cells and tissues.

Cell-based Treatments for Orthopedic Conditions

There are two types of cell-based therapies that can be used to treat orthopedic conditions:

Bone Marrow Aspiration Concentrate (BMAC): Bone marrow-derived cells are collected from the back of the pelvic bone. The marrow contains mesenchymal stem cells which have the ability to renew themselves and differentiate into bone, tendon, cartilage and muscle cells. These make them an ideal therapy for treating orthopedic injuries such as tendon tears, worn cartilage, and degenerated disc disease. BMAC also contains important therapeutic cells, growth factors and proteins that stimulate the body’s natural ability to improve circulation, decrease inflammation and heal injured tissues. 

Micro-fragmented Adipose Tissue (fat) Cells:  Adipose-derived cells are collected from a fat sample usually from the buttock or abdomen. There is minimal manipulation of the tissue with no enzymatic digestion or addition of other biological or pharmacological agents. Fat or adipose tissue is rich in healing cells like mesenchymal stem cells or MSCs, growth factors and other proteins that can assist in healing tissues. 

Why Consider Cell-Based Therapies?

There is increasing body of clinical research that demonstrates the safety and efficacy of Cell based therapies. A recent comprehensive report 1  based on actual clinical data collected from 65 physicians at 43 clinics in 25 states revealed that seventy percent of the patients treated with adipose tissue therapy reported a meaningful reduction in pain at 12 months following treatment and sixty-one percent of the patients treated with bone marrow aspirate reported a meaningful reduction in pain at12 months following treatment. 

Micro-fragmented adipose tissue or bone marrow aspirate concentrate is a non-surgical treatment option that does not involve incisions, general anesthesia, hospitalizations or lengthy rehabilitation stays. This is an outpatient procedure performed in a doctor’s clinic using only local anesthesia.

Patients considering cell-based therapies should do their research in ensuring they get the best treatment. There are several important factors that can impact the effectiveness of these treatments. These include:

  • Cellular product preparation:  The patient’s bone marrow or fat tissue must be processed using FDA compliant devices and protocols. It must be prepared in a safe and sterile environment by medical personnel who are trained in the proper handling of these tissues. 
  • Delivery: The procedure must be performed by skilled physicians who are properly trained in this field. They must be able to perform these highly specialized injection techniques using imaging guidance to ensure that the cellular products are delivered to the site of injury.
  • Experience: The field of regenerative medicine is changing daily and there are a limited number of specialists around the country who have the experience and technology to perform cell-based orthopedic treatments safely and effectively. Dr. Mary A. Ambach and Dr. Chris Rogers have decades of experience in using regenerative therapies and are nationally recognized experts in this field. 

 1Databiologics. An Overview of Regenerative Treatments for Orthopedic Conditions. 2021 Outcomes Report.

Common Conditions Prolotherapy Can Treat

Common Conditions Prolotherapy Can Treat

Prolotherapy, also known as proliferative therapy, is a treatment used to boost the body’s own natural healing capabilities to reduce inflammation, stimulate proliferation of injured tissue and relieve pain.

This is a minimally invasive therapy that involves injection of natural solutions to the injured tissue to stimulate healing. The main ingredient in the injection is dextrose, a sugar solution, which acts as an irritant to the body.  The body reacts to the dextrose by stimulating repair and activating its natural healing abilities. The patient experiences relief as the injured tissue strengthens and heals. 

What Conditions Can Prolotherapy Treat?

Prolotherapy can be used to treat any number of orthopedic conditions including:

  • Osteoarthritis
  • Ligament sprains 
  • Ligament laxity
  • Tennis elbow 
  • Tendinopathy
  • Sacroiliac joint ( SI joint) dysfunction
  • Achilles tendinopathy

What Does Prolotherapy Entail?

Your physician will first complete an appropriate clinical evaluation and diagnostic testing to determine if you are a good candidate for prolotherapy. The procedure is a minimally invasive procedure performed in a medical clinic using local anesthesia. You may be asked to discontinue anti-inflammatory medications 3-5 days prior to the procedure.  The procedure is performed using ultrasound or fluoroscopic guidance for precise localization of target and delivery of the solution. A small needle is used to inject the prolotherapy solution to the injured area using imaging guidance. Depending on the extent of the injury, a series of injections performed a few weeks apart may be needed for a successful treatment. You will be asked to take it easy for a few days and return to normal activity and exercises after 3-5 days. The procedure is very well tolerated with no downtime.

How Effective is This Type of Therapy?

Prolotherapy is a proven treatment that has been in use for more than 80 years and is practiced by physicians around the world. A review in the US National Library of Medicine of the National Institutes of Health evaluated 32 studies on dextrose prolotherapy for chronic musculoskeletal pain. It concluded that “dextrose prolotherapy has been demonstrated to be efficacious and should be considered as a treatment for pain and dysfunction associated with chronic musculoskeletal conditions, particularly tendinopathies and osteoarthritis.”[i] 

A good review of prolotherapy treatments can be found here and here.

To learn more about SDOMG and how they have successfully utilized prolotherapy for more than three decades, fill out the form below:

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Drs. Mary A. Ambach and Chris Rogers of San Diego Orthobiologics Medical Group have successfully treated hundreds of patients with prolotherapy and other cell-based treatments for more than three decades. Their state -of- the- art facility in Carlsbad offers the most advanced Regenerative Medicine treatments in San Diego with the highest level of safety and efficacy. 

[i] https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4938120/

Dr. Ambach lectures to Physicians and Orthopedic Surgeons on Practical Spine Orthobiologics

Dr. Ambach lectures to Physicians and Orthopedic Surgeons on Practical Spine Orthobiologics

Dr. Mary Ambach lectures to physicians, orthopedic surgeons and other orthopedic practitioners on the use of Platelet Rich Plasma and Stem Cell Therapies for the Spine.

Dr. Ambach is one of the esteemed instructors in this Orthobiologic seminar who taught physicians on how to perform regenerative injections and diagnostic musculoskeletal ultrasound scans.

Dr. Ambach has served as faculty and speaker at regenerative conferences in and outside of the country. She has mentored many doctors all over the world in innovative procedures using cell therapies from our own bodies to heal our own orthopedic injuries.

How can Bone Marrow-derived Cells Treat Disc Disease     

How can Bone Marrow-derived Cells Treat Disc Disease     

The bones of the spine called vertebrae are separated by shock-absorbing discs that act as a cushion. These discs have a strong cartilaginous outer portion and a gel-like inner core. When these discs begin to break down from either age or injury, they can result in disc bulging or what is also known as disc herniation.  The discs can also tear, decrease in height or dry out. These changes in the discs can cause pain and pressure on nearby nerves ( radiculopathy). They can also cause degeneration of nearby facet joints and narrowing of the canal (spinal stenosis).

Degenerative disc disease often occurs as part of the aging process. By age 40, it is estimated that 40 percent of the population will have some degree of degenerative disc disease and by age 80, that percentage doubles.[1]

Symptoms from degenerative disc include neck pain, back pain, muscle spasms or radiating pain to the arms or legs. Pain is typically worse with bending forward or prolonged sitting. 

The current standard treatment for degenerative or herniated discs includes physical therapy, medications, injection therapy, and surgery. These aim to provide symptomatic relief of the pain but most do not improve the pathology or reverse the degenerative process. 

Treatment with Bone marrow-derived cells has introduced a unique approach to alleviate pain and improve function by restoring and repairing tissue injury.

What is Bone Marrow Aspirate Concentrate (BMAC)?

The body’s bone marrow possesses unique properties that help the body heal itself naturally. It contains important therapeutic cells, growth factors and proteins that stimulate the body’s natural ability to improve circulation, decrease inflammation and heal injured tissues. 

It also contains adult stem cells called Mesenchymal stem cells. These stem cells have the special ability to renew themselves and differentiate into bone, tendon, cartilage and muscle cells. These make them an ideal therapy for treating orthopedic injuries such as tendon tears, worn cartilage, and degenerated disc disease. 

Bone marrow-derived cells have been shown to stimulate disc cell proliferation, increase disc support tissue, increase disc hydration, decrease inflammation, and support tissue healing. 

How Effective is BMAC?

A study published by International Orthopedics reported the results of 26 patients suffering from degenerative disc disease and were candidates for major surgery such as spinal fusion or total disc replacement who underwent BMAC therapy to their discs. Three years later, 73% of these patients showed improvement in pain, 70% showed improvement in function, and 75% avoided surgery.[2] 

A systematic review of seven clinical trials with a total of 97 patients and up to 72 months follow-up concluded that treatment with Bone Marrow-derived cells intradiscally showed significant improvement in pain and function with low re-injection or complication rates.

BMAC therapy is a minimally invasive, non-surgical procedure that does not require hospitalization or lengthy rehabilitation. Patients are generally able to begin physical therapy and gradual resumption of their daily activities within a week.

For patients who suffer from chronic low back pain from degenerative disc disease and failed standard conservative therapy, BMAC therapy performed by an experienced regenerative medicine specialist can provide an innovative, non-surgical treatment solution. Schedule a consultation with our renowned regenerative medicine physicians to see if you are a candidate for these therapies before considering spinal surgery. 

Drs. Christopher J. Rogers and Mary A. Ambach of San Diego Orthobiologics Medical Group together have successfully treated hundreds of patients with BMAC and other cell-based treatments for more than three decades. They have published authors and stem cell researchers. Their FDA-compliant facility in Carlsbad contains the most advanced Regenerative Medicine technology in San Diego and offers same-day treatments with the highest level of safety and efficacy.

 [1] https://pubmed.ncbi.nlm.nih.gov/23074480/[1]

[2] https://pubmed.ncbi.nlm.nih.gov/28748380/

[3] https://www.cureus.com/articles/36347-systematic-review-is-intradiscal-injection-of-bone-marrow-concentrate-for-lumbar-disc-degeneration-effective 

Fat-derived Cell based therapy: What it is and How it is Used

Fat-derived Cell based therapy: What it is and How it is Used

Like many things in life, when it comes to body fat moderation is key. Your body needs fat tissue to help its vital systems including the cardiovascular, endocrine, reproductive and central nervous systems, function properly.  But too much body fat is harmful and can lead to increased risk for chronic conditions such as heart disease, diabetes and arthritis.

Now, regenerative medicine specialists are putting fat’s natural healing abilities to work to address common orthopedic conditions such as joint and tendon injuries.

What is Micro-fragmented Adipose Tissue? 

Fat or adipose tissue is rich in healing cells like mesenchymal stem cells or MSCs, growth factors and other proteins that can assist in healing tissues. Innovative procedures, like Lipogems® uses the body’s own fat with a patented system that processes and resizes the adipose tissue.  A small amount of fat is collected from the buttocks, abdomen or “love handles.”  There is minimal manipulation of the tissue with no enzymatic digestion or addition of other biological or pharmacological agents.

The processed tissue is called Micro-fragmented Adipose Tissue (MFAT) and it is injected into injured areas using imaging guidance to help provide cushion and support the healing of damaged tissues. The entire procedure is performed in a doctor’s clinic without the need for sedation. 

What Are the Outcomes for Lipogems®?

There are more than 70 research studies published in the peer-reviewed medical literature using this treatment with up to 3 years of follow-up. More than 90 percent of San Diego Orthobiologics Medical Group patients who underwent Lipogems® experienced significant relief with the treatment and were able to resume normal, pain-free physical activity.  More than 35,000 procedures are performed worldwide with a low rate of minor complications and no major complications reported. There is no risk of rejection and low risk of infection since you are using your own tissue. Individual outcomes vary based on the extent of the injury or damage as well as the patient’s overall health and fitness levels.

Fat-derived cell based therapies is a great non-surgical treatment option for patients with orthopedic injuries or conditions who failed standard therapies. Learn more about these therapies here and here. Schedule a consultation with our innovative Regenerative Medicine doctors to determine if you are a good candidate for these treatments.

Drs. Christopher J. Rogers and Mary A. Ambach of San Diego Orthobiologics Medical Group together have successfully treated thousands of patients with Lipogems® and other cell-based treatments for more than three decades. They are published authors and stem cell researchers. Their facility in Carlsbad contains the most advanced Regenerative Medicine technology in San Diego and offers same-day treatments with the highest level of safety and efficacy.

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