Why Have a Stem Cell Treatment?

Regenerative medicine aims to repair, replace, or regenerate damaged or missing tissue or organs and make them perform as closely as possible to their natural abilities.

As seen previously, adult stem cells can differentiate into many specialized cells, making them ideal for regenerative medicine applications. A study by the American Academy of Pediatrics mentioned in the introduction found that many injuries increasingly happen at a relatively young age. Young patients are likely to outlive the useful life of a total knee replacement (TKR), the current definitive therapy for osteoarthritis (OA).

Left untreated, cartilage injuries typically result in degenerative joint disease or OA, which causes pain and disability. Combine this trend with rising life expectancy, and it’s not surprising that the number of Americans with OA will surge to 67 million by 2030, leading to a seven-fold increase in total knee replacements (TKRs).

Used correctly, stem cells can enhance cartilage repair and regeneration via an intra-articular injection (joint injection) or surgical implantation. The positive therapeutic effect of stem cells and the procedure’s overall safety and efficacy have made it the most promising treatment for osteoarthritis.

This page is organized like an FAQ, with citations from research papers published around the world following each question.

Do Stem Cell Treatments Work?

Two questions frequently googled include “how stem cells work” and “can stem cells work for fill-in-the-blank.” Here are some study results that may answer those questions:

This study demonstrates that concentrated bone marrow aspirate (BMA) with one-step implantation of mesenchymal stem cells can be a viable alternative in the treatment of grade IV chondral (cartilage) lesions of the knee. Furthermore, this procedure offers the advantage of a lower cost compared with standard ACI (Autologous Chondrocyte Implantation — using surgery to harvest normal cartilage, then surgically reimplanting that cartilage after it has been cultured in the lab).

Source: 180 patients with full thickness chondral defect – Arthroscopy Journal (2010)

In men aged 50+, osteoarthritis represents the second leading cause of work disability. Furthermore, osteoarthritis is responsible for approximately 2% of all public health expenses and large indirect costs derived from productivity decreases [in Spain]. Many treatments have been proposed but resulted in poor clinical results without cartilage repair. Articular replacement with prostheses is only recommended as the last treatment option.

The American Academy of Orthopedic Surgeons recommends only physical and educational therapy, symptomatic treatment with acetaminophen or nonsteroidal anti-inflammatory drugs, and sometimes local corticosteroid injection. Recommendations of the American College of Rheumatology are very similar. Common treatments, including physical therapy, viscosupplementation, glucosamine and/or chondroitin sulfate, arthroscopic surgery, acupuncture, and ultrasound, have demonstrated modest to no clinical benefit compared with placebo.

We conducted a pilot study to test the technique’s feasibility and safety and to obtain an early indication of the therapeutic value of MSC treatment in 12 human patients with grades II to IV chronic knee osteoarthritis who were unresponsive to conventional treatments.

Our results suggest that MSC treatment improves pain and other clinical signs and, in some cases, delays or even reverts the cartilage damage of osteoarthritis. Pain was significantly reduced by 3 months after MSC transplantation followed by a smaller additional progressive improvement during the subsequent 9 months. The MSC healing effect was quite rapid: the improvement at 3 months was 69% of the value obtained at 12 months. The recovery of function losses is less but also significant, and there is quantitative evidence of partial articular cartilage healing.

Source: Treatment of Knee Osteoarthritis With Autologous Mesenchymal Stem Cells (2013)

Thus far this review has focused on stem-cell-based cartilage tissue engineering strategies for end-stage OA, but emerging evidence indicates that the direct injection of stem cells into the joint can boost the normally limited repair and limit destructive processes.

Source: Stem cell-based therapies for osteoarthritis: Challenges and opportunities (2013)

Patients with osteoarthritic changes who received mesenchymal stem cells experienced a significant reduction in pain compared with those who received the control, on the basis of visual analog scale assessments. There was evidence of meniscus regeneration and improvement in knee pain following treatment with allogeneic human mesenchymal stem cells. These results support the study of human mesenchymal stem cells for the apparent knee-tissue regeneration and protective effects.

Source: Adult Human Mesenchymal Stem Cells Delivered via Intra-Articular Injection to the Knee Following Partial Medial Meniscectomy (2014)

Our RCT showed statistically significant avoidance of total knee arthroplasty, and potent, early, and sustained symptom alleviation. Total WOMAC scores showed statistically significant improvements at 6 and 12 months for the AAPBSC (autologous activated peripheral blood stem cells) groups versus controls. [Note: This study used arthroscopic microdrilling and what appears to be intra-osseous (in bone) injections for the placement of peripheral blood stem cells (PBSC). Furthermore, the study used growth factor additions (GFA), including PRP and human granulocyte colony-stimulating factor (hG-CSF), which most providers may not offer.]

Source: Avoidance of Total Knee Arthroplasty in Early Osteoarthritis of the Knee with Intra-Articular Implantation of Autologous Activated Peripheral Blood Stem Cells versus Hyaluronic Acid: A Randomized Controlled Trial with Differential Effects of Growth Factor Addition (2017)

Patients who received a specific protocol of BMC and platelet products improved significantly in activity levels (shown by LEAS), as well as pain, ROM and stability as assessed by the KSS-knee score compared to patients who underwent a home exercise therapy program for 3 months for the treatment of moderate knee OA.

Source: A specific protocol of autologous bone marrow concentrate and platelet products versus exercise therapy for symptomatic knee osteoarthritis: a randomized controlled trial with 2 year follow-up (2018)

What Can Stem Cells Cure?

During a four-week period in September and October 2020, most likely driven by the Covid-19 pandemic, “stem cell treatment” searches peaked at 308,000. But during any given month, more than 200,000 search queries are performed by people hoping to find cures for afflictions.

Below is a list of highly sought-after stem cell cures, ranked in order of search popularity:

It should be noted that in 2005, a team of University of Minnesota stem cell researchers published a paper that reported that, for the first time, human embryonic stem cells were coaxed to create cancer-killing cells in the laboratory, setting the stage for future treatment of various types of cancers and tumors.

In the current U.S. climate, such research is strictly prohibited from continuing, although it demonstrably could save lives or improve living quality for many.

The list above also proves that the disruptive potential of using stem cells to cure all types of human, and animal, ailments has galvanized medical researchers around the globe to search for new ways to harness this exciting new technology.

What Can Stem Cell Treatments Be Used For?

There is disagreement over the ability of stem-cell therapies to regrow cartilage. Below is a pro-stem cells POV:

The size of cartilage defect decreased while the volume of cartilage increased in the medial femoral and tibial condyles of the high-dose group. Arthroscopy showed that the size of cartilage defect decreased in the medial femoral and medial tibial condyles of the high-dose group. Histology demonstrated thick, hyaline-like cartilage regeneration. These results showed that intra-articular injection of AD (adipose) MSCs into the osteoarthritic knee improved function and pain of the knee joint without causing adverse events, and reduced cartilage defects by regeneration of hyaline-like articular cartilage.

Source: Intra-Articular Injection of Mesenchymal Stem Cells for the Treatment of Osteoarthritis of the Knee: A Proof-of-Concept Clinical Trial (2013)

What Can Stem Cells Not Do?

And here’s research suggesting no cartilage success:

Since the work of Johnstone et al., Barry et al., and Pittenger et al., it is known that bone marrow-derived MSCs (BM-MSCs) can form a cartilage-like tissue in vitro under the guidance of specific cocktails of growth factors. The resulting differentiated tissue can be classified as cartilage in that it expresses many biomolecules typical of hyaline cartilage, such as type II collagen and the proteoglycan, aggrecan. However, the proportion of the chemical constituents tends to be wrong for true weight-bearing hyaline articular cartilage.

Source: Chondrogenic Differentiation of Mesenchymal Stem Cells: Challenges and Unfulfilled Expectations (2014)

Unfortunately, some personalities are spreading incorrect information, like Tony Robbins who told Fox 5 New York that a single “IV injection” cured his completely torn rotator cuff.

Stem cell treatment certainly can’t cure a completely torn rotator cuff in three days, as Tony Robbins claimed in a nine-minute television interview with Fox 5 New York. In the interview, Tony says he had spinal stenosis and a completely torn rotator cuff. An intravenous injection (IV) of umbilical-derived stem cells plus “a shot” cured him in a few days.

Spinal stenosis is when the spinal canal, or areas where nerves exit, are too tight due to bone spurs, overgrown ligaments, or disc bulges. This irritates nerves and causes pain. Tony doesn’t mention any spine injections, just “a shot” in his shoulder.

Could stem cells administered via an IV have healed his shoulder and low back in a few days? Not likely, because injecting stem cells via a vein is subject to a “pulmonary first-pass effect,” which means that 95% of the mesenchymal stem cells (MSCs) get stuck in the lungs.

So how did the stem cells make it to this area? Constricted nerves also have a poor blood supply, so any stem cells traveling through arteries would likely not make it to these nerves. Discs also have few or no blood vessels, so getting to the right area is challenging. Bone spurs could have been reached but changing their shape with stem cells has never been reported.

Here’s the complete Tony Robbins takedown by Dr. Chris Centeno.

Stem Cell Treatment Results

A large number of studies have investigated stem cells, with many providing contradictory results. Here are some of the most significant findings:

Synovium-derived cells, in particular, had the greatest ability for chondrogenesis. In adipogenesis experiments, the frequency of oil red O–positive colonies was highest in synovium- and adipose tissue–derived cells. Interestingly, colony number per 103 nucleated cells derived from synovium, periosteum, adipose tissue, and muscle was ␑100-fold higher than that derived from bone marrow. Adipose tissue–derived MSCs had a lower proliferation potential than the other mesenchymal tissue–derived MSCs we examined.

Source: Comparison of Human Stem Cells Derived From Various Mesenchymal Tissues (2005)

Thus, synovium- and bone-marrow-MSCs had greater in vivo chondrogenic potential than adipose- and muscle-MSCs, but synovium-MSCs had the advantage of a greater proliferation potential.

Source: Comparison of mesenchymal tissues-derived stem cells for in vivo chondrogenesis: suitable conditions for cell therapy of cartilage defects in rabbit (2008)

So that’s two studies suggesting that stem cells from synovial fluid (found in the knee) provided superior results. Keep in mind that these were early studies and more recent research has turned its attention to adipose (fat) and bone marrow aspirate (BMA) stem cells, such as:

Adult stem cells derived from adipose-derived stem cells (ASCs) and bone marrow (bone marrow–derived mesenchymal stem cells, MSCs) have shown significant chondrogenic potential for tissue engineering.

Source: Chondrogenesis of adult stem cells from adipose tissue and bone marrow: induction by growth factors and cartilage-derived matrix (2009)

Chondrogenesis is the process by which cartilage is formed from mesenchymal stem cells, which differentiate into chondrocytes (cells responsible for cartilage formation) and secrete molecules that form the extracellular matrix.

With regard to proliferation potential, our study shows that bone-marrow-derived cells have much higher proliferation potential than synovium-derived cells, which indicates that bone-marrow-derived cells are a superior cell source for cartilage regeneration. Our study indicates that it is not the cells from synovium but the synovial fluid and cavity environment which lead to successful chondrogenic repair.

Source: Comparing the chondrogenic potential in vivo of autogeneic mesenchymal stem cells derived from different tissues (2010)

UCB-MSCs have a longer culture, a large scale expansion, retardation of senescence, and a higher anti-inflammation effect via Ang-1 than other MSCs.

Source: Comparative Analysis of Human Mesenchymal Stem Cells from Bone Marrow, Adipose Tissue, and Umbilical Cord Blood as Sources of Cell Therapy (2013)

When compared among themselves, adipose tissue-derived MSCs seem to be ahead because of a higher number of cells per gram of tissue, higher cell proliferation rate compared to others and technical convenience to obtain cells.

Source: Therapeutic Applications of Stem Cells and Extracellular Vesicles in Emergency Care – Futuristic Perspectives (2021)

Bone marrow aspirate concentrate (BMAC) and human umbilical cord blood-derived mesenchymal stem cells (hUCB-MSCs) implantations were approved by the South Korean FDA. At a 2-year follow-up, clinical outcomes including VAS, IKDC, and KOOS significantly improved in both groups; however, there was no difference between the two groups. Both groups showed satisfactory clinical and MRI outcomes. Implantation of MSCs from BMAC or hUCB-MSCs is safe and effective for repairing cartilage lesions.

Source: Comparison of Bone Marrow Aspirate Concentrate and Allogenic Human Umbilical Cord Blood Derived Mesenchymal Stem Cell Implantation on Chondral Defect of Knee: Assessment of Clinical and Magnetic Resonance Imaging Outcomes at 2-Year Follow-Up (2020)

Bone Marrow Aspirate Concentrate vs. MFAT

On page 60 of Regenexx’ “The Spine Owner’s Manual,” there is this quote from Chris Centeno:

“Thirteen papers show that bone marrow stem cells are better at producing cartilage than fat stem cells, while none show that fat stem cells are better than bone marrow.”

A link to an article where one can download an infographic linking to those 13 papers is also provided: “Fat vs bone marrow stem cells for arthritis.”

While Centeno echoes a prevailing point of view, it should be noted that he hasn’t updated this article since 2015, and many more papers have been published since that suggest adipose tissue stem cells (ASCs) do work for the knee and back. One particular study, “Stem cell therapy in discogenic back pain,” lists nine papers on the use of adipose tissue in stem-cell therapies.

Another recent study, “Autologous Micro-Fragmented Adipose Tissue (MFAT) to Treat Symptomatic Knee Osteoarthritis,” cites these key advantages:

Higher concentration of MSCs

“For autologous transplantation purposes, bone marrow and adipose tissue are the two predominant sites for MSC harvest. Although MSCs from both origins appear to have a similar differentiation potential, bone marrow harvest is more invasive and the substrate contains a lower relative concentration of MSCs compared to adipose tissue.”

More viable stem cells

”Moreover, the viability and differentiation capacity of bone marrow MSCs is affected by age, which seems highly relevant considering the majority of knee OA patients are middle-aged.”

More easily harvested; MFAT produces better results

”Subcutaneous fat tissue possesses an easily accessible and often abundant stock to harvest MSCs (AMSCs). Minimally invasive lipo-aspiration can be performed under local anesthesia in the outpatient setting. Next, the lipoaspirate can either be processed enzymatically or mechanically, which has recently been found to result in important differences regarding the final product. In micro-fragmented adipose tissue (MFAT) processing, the lipoaspirate is refined to a cluster of 0.2–0.8 mm while the supportive vascular stromal niche remains intact and MSCs/pericytes stay in their natural habitat.”

What Helps a Stem-Cell Treatment Succeed?

There are many factors that influence the successful outcome of a stem cell treatment, including patient physician skills, equipment, and techniques used. Some of the research studies suggest that the ideal stem-cell patient is under the age of 60, although others disagree.

Age

Aging appears to impair the function of stem cells and is thus a significant roadblock to using stem cells for therapy, at least in the study below. Paradoxically, patients who would benefit most from regenerative therapies are usually advanced in age.

Patients were excluded if they were older than 60 years, had either an inflammatory joint disease, severe osteoarthritis (Kellgren-Lawrence stage larger than 4), severe or uncontrolled diabetes, or obesity with BMI greater than 30.

Source: Avoidance of Total Knee Arthroplasty in Early Osteoarthritis of the Knee with Intra-Articular Implantation of Autologous Activated Peripheral Blood Stem Cells versus Hyaluronic Acid: A Randomized Controlled Trial with Differential Effects of Growth Factor Addition (2017)

Regenexx’ Dr. Chris Centeno provides this counterargument:

It would be simple to assume that since older patients have fewer, aging stem cells, treatments using their own stem cells would show poorer outcomes. However, based on our data and research publications, that relationship largely does not exist. For example, in knee stem cell treatments, we found no correlation between age and outcome when comparing age groups (i.e., ≤50 years, 51–60 years, and >60 years). In treating orthopedic conditions, age does not affect stem cell treatment success. Older patients do just as well as younger patients with precise injections of their own stem cells. In fact, the only exception to a negative correlation between age and outcome that we have seen thus far is hip arthritis. We found that patients ≤ 55 years old were more likely to report greater than 50% improvement.

Source: Does Age Affect Stem Cell Treatment Success? (2021)

Obesity

Overweight patients put a lot of stress on their joints. They also make a less than ideal candidate for stem cell treatment:

ASCs and other stem cells from obese patients may be compromised by the presence of low-grade systemic inflammation that is associated with obesity. Indeed, ASCs derived from the visceral fat of morbidly obese patients showed a reduced proliferation rate, greater cell senescence, and a reduced differentiation to multiple lineages including chondrogenesis.

Source: Stem cell-based therapies for osteoarthritis: Challenges and opportunities (2013)

Advanced Imaging Guidance

Stem cells need to be placed into very specific areas causing pain. This requires advanced imaging guidance and training to do safely. Getting an intra-articular injection (joint injection) procedure done by a nurse practitioner (NP), physician’s assistant (PA), or even a non-trained family physician is not a viable option.

The minimum requirement is having a trained specialist use ultrasound to guide the injection into the joint. Ultrasound devices bounce sound waves into the body and use a computer to generate an image. While ultrasound is a good first step, it cannot penetrate bone. That requires the use of another device

In those cases, advanced providers use an x-ray technology known as fluoroscopy. Digital fluoroscopy offers better penetration of anatomy, particularly the latest generation of flat panel detector (FPD) based systems, which use direct digital radiography (DDR) to convert x-rays into light.

The effectiveness of these devices has been proven in a meta-analysis of 42 pertinent studies of a total of 406 injections, of which 115 were fluoroscopy-guided and 291 were ultrasound-guided. The proportion of joints successfully injected with ultrasound and fluoroscopic guidance was 93% and 80%, respectively. Unfortunately, there are no studies comparing blind, free-hand injections with image-guided ones, but given the success rate of these devices, one can only make an educated guess that they suffer in comparison.

These are expensive devices with Healthcare Finance reporting that the average cost was $535,961 in 2015. With “supply chain” issues that many are using to artificially raise prices, expect costs to soar.

 
Mobile C-arm fluoroscopic x-ray systems are used for a variety of diagnostic imaging and minimally invasive surgical procedures, including orthopedics and orthobiologics. Digital systems, like this Siemens Cios Fusion, use flat-panel detector (FD) technology to simplify visualization while designed for increased mobility.

You can get a mid-tier ultrasound unit for $20,000–$30,000. A mid-tier ultrasound and mobile C-arm fluoroscopy device puts the cost well north of $250,000. In addition, you also need a specially built room with custom drywall, which is two to three times as large as the typical exam room size, plus an expert radiologist to run both machines, which adds another $80,000 a year.

Now you know why fewer than 5% of stem cell clinics around the world are properly equipped to perform a high-quality stem cell treatment, and why prices in Colombia, Mexico, Panama, etc. are so low.

Of course, a run-of-the-mill practice can pick up a used Siemens Orbic C-Arm fluoroscopy device for $16,666 on eBay with free local pick up in Chicago. 😁 This is why I usually ask the practitioner if it’s OK to have a companion take pictures of the procedure, so you have an accurate record of the devices used.

Injection Needle and Trocar

There is an ongoing debate as to what constitutes the right size needle, ditto for the trocar, which is a surgical instrument with a three-sided cutting point enclosed in a tube, used for withdrawing, or injecting, fluid from a body cavity. Both use “gauge” (abbreviated as “G”) measurement, which refers to the needle’s hole size.

Injection Needle

Bone marrow from the tibia was obtained with an 18-gauge needle just before drilling for the insertion of reconstructed ligaments.

Source: Comparison of Human Stem Cells Derived From Various Mesenchymal Tissues (2005)

Bone marrow was abstracted from inferior extremity metaphysis of femur with an 18-gauge needle.

Source: Comparing the chondrogenic potential in vivo of autogeneic mesenchymal stem cells derived from different tissues (2011)

Finally, the refined adipose substrate was aseptically injected under ultrasound guidance from the lateral side of the index knee with an 18 gauge needle by an experienced interventional radiologist.

Source: Autologous Micro-Fragmented Adipose Tissue (MFAT) to Treat Symptomatic Knee Osteoarthritis (2021)

Trocar
A trocar is used to draw bone marrow and for intraosseous (in-bone) injections.

A 13-gauge trocar used for bone biopsy (CareFusion, San Diego, CA) is introduced into the bone through the mark previously made.

Source: Intraosseous Infiltration of Platelet-Rich Plasma for Severe Knee Osteoarthritis (2014)

Intraosseous infiltrations were performed with a 13 G trocar used for bone biopsy, which was manually introduced into the bone and inserted 2 cm into the medial tibial plateau and medial femoral condyle.

Source: Combination of Intra-Articular and Intraosseous Injections of Platelet Rich Plasma for Severe Knee Osteoarthritis: A Pilot Study (2016)

The decompression was performed with a percutaneous approach using a 3-mm diameter trephine trocard (Mazabraud, Collin, France).

Source: Stem Cell Therapy for the Treatment of Hip Osteonecrosis: A 30-Year Review of Progress (2016)

Intraosseous injections are performed on the tibial plateau and the femoral condyle using either an 11, 13, or 15 gauge trocar for both cases.

Source: Current concepts in intraosseous Platelet-Rich Plasma injections for knee osteoarthritis (2020)

Quantities and Volumes

Aspiration and injection quantities are another mundane topic typically abused by shady providers. Here’s real-world data with BMAC injections 30 ml and aspiration of 60 ml PRP injections averaging 5 ml (milliliters) and.

Aspiration

For bone marrow harvest, two 30-mL syringes and a traditional 11-gauge, 11-cm Jamshidi needle (Ranfac) were prerinsed with heparin.

Source: Bone Marrow Aspirate Concentrate Is Equivalent to Platelet-Rich Plasma for the Treatment of Knee Osteoarthritis at 1 Year (2020)

Approximately 60 mL of bone marrow is aspirated, which requires the use of two 30-mL syringes.

Source: Bone Marrow Aspirate Concentrate Harvesting and Processing Technique (2017)

The metric below is for the adipose stem cell procedure known as MFAT (Micro-Fragmented Adipose Tissue), which we will cover in an update.

In this way, 3–4 syringes of approximately 12 cc MFAT were obtained per patient. The remaining fluid in the syringes was separated and removed to increase the AMSCs concentration, which yielded a final MFAT product per subject of 1–2 syringes filled with 8–10 cc/syringe.

Source: Autologous Micro-Fragmented Adipose Tissue (MFAT) to Treat Symptomatic Knee Osteoarthritis (2021)

Meaning that you would use [a trocar] to perform a typical 60 ml bone marrow aspiration and then further concentrate the cells.

Source: Marrow Cellution: Playing Games with Bone Marrow Data in New Jersey (2022)

BMAC (+ PRP) Injection

A 5–7 cc injectate solution consisting of approximately 75% by volume of BMC, 12.5% by volume PRP, and 12.5% by volume PL was percutaneously injected, specifically targeting the sites of greatest chondral loss.

Source: A specific protocol of autologous bone marrow concentrate and platelet products versus exercise therapy for symptomatic knee osteoarthritis (2018)

BMAC contains only a small fraction of MSCs. In general, we can extract about 19,000,000 mononuclear cells of approximately 6 ml capacity after aspirating 60 ml of bone marrow.

Source: Comparison of Bone Marrow Aspirate Concentrate and Allogenic Human Umbilical Cord Blood Derived Mesenchymal Stem Cell Implantation on Chondral Defect of Knee: Assessment of Clinical and Magnetic Resonance Imaging Outcomes at 2-Year Follow-Up (2020)

PRP Injection

Once the trocars were placed in the desired position, 5 mL of PRP was infiltrated into subchon- dral bone of each structure.

Source: Combination of Intra-Articular and Intraosseous Injections of Platelet Rich Plasma for Severe Knee Osteoarthritis: A Pilot Study (2016)

Are Stem Cell Treatments Safe?

How safe are stem cell treatments? Here are some research study findings starting in 2013 and ending in 2021:

Our results show that autologous MSC transplantation is both feasible and safe, with no major adverse events recorded.

Source: Treatment of Knee Osteoarthritis With Autologous Mesenchymal Stem Cells (2013)

No ectopic tissue formation or clinically important safety issues were identified.

Source: Adult Human Mesenchymal Stem Cells Delivered via Intra-Articular Injection to the Knee Following Partial Medial Meniscectomy (2014)

Implantation of MSCs from BMAC or hUCB-MSCs is safe and effective for repairing cartilage lesion.

Source: Comparison of Bone Marrow Aspirate Concentrate and Allogenic Human Umbilical Cord Blood Derived Mesenchymal Stem Cell Implantation on Chondral Defect of Knee: Assessment of Clinical and Magnetic Resonance Imaging Outcomes at 2-Year Follow-Up (2020)

Comprising the 2017 RCT of Turajane et al. would have included a second RCT in the review, thus considerably strengthening the conclusion that autologous PBSCs show superiority in procurement, safety, and positive therapeutic effects in clinical settings where cartilage repair and regeneration are required.

Source: Commentary: Autologous Peripheral Blood Stem Cells (PBSC) are Safe and Effective in Knee Osteoarthritis (2021)

What Stem Cell Treatments Are FDA-Approved?

The following quote was excerpted from an article posted on the Food and Drug Administration (FDA) website in Sept. 2019:

The only stem cell-based products that are FDA-approved for use in the United States consist of blood-forming stem cells (hematopoietic progenitor cells) derived from cord blood. These products are approved for limited use in patients with disorders that affect the body system that is involved in the production of blood (called the “hematopoietic” system). These FDA-approved stem cell products are listed on the FDA website. Bone marrow also is used for these treatments but is generally not regulated by the FDA for this use.

Source: FDA Warns About Stem Cell Therapies (Sept. 2019)

Hematopoietic stem cells are immature cells that can develop into all types of blood cells, including white and red blood cells, and platelets. Hematopoietic stem cells are found in peripheral blood (blood circulating throughout the body) and bone marrow.

It should be noted that while the FDA has officially only approved one stem cell treatment, more than 13,000 patients have received this type of therapy and had their results published and indexed in the U.S. Library of Medicine.

Why have so many procedures been performed despite just one treatment approval? The FDA provides almost no regulatory oversight of orthopedic procedures using bone-marrow extracts or platelets because they’re considered low risk.

While the FDA has the authority to regulate stem cell treatments, it adopted an industry-friendly approach in 2017 by giving organizations a three-year grace period in which to describe their products or treatments so the agency could determine whether they meet the criteria of drugs that would require agency approval. Thus far, few companies have submitted any stem cell treatment information.

The “compliance and enforcement discretion policy for certain human cell, tissue, and cellular tissue-based products” The New York Times refers to ended May 31, 2021.

This post will be enhanced with more research as it becomes available.