Stem cells are primordial cells that exist in the embryo, fetus, umbilical cord, amniotic sac, adult fat, adult bone marrow, and in small quantities in many organs in the adult body.  The early stem cells (embryonic, fetal) have the ability to differentiate into any tissue, cell, or grow any organ.  There is a possibility of organ repair with stem cells but depends on the viability of the stem cells, the blood supply to the area injected, and the presence of the nutrient building blocks for creation of structures made by stem cells.

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TYPES OF STEM CELLS USED IN REGENERATIVE MEDICINE

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FAT DERIVED ADULT STEM CELLS -  These stem cells are obtained by performing a limited but frequently painful liposuction on the abdomen to obtain adipose tissue, that is then washed and centrifuged.  The final product is composed of about <1% stem cells and the rest cellular debris, fibroblasts, blood, etc. that cannot be further purified under current FDA regulations.  Some of these other cells and debris can be damaging to organs and tissues.  Stem cell clinics charge up to $20,000 cash for each treatment with this stem cell brew that is akin to injecting cellular debris into potentially sensitive structures of the body.  The main safety issues are that you cannot sterilize the stem cells, and if there were any breach in sterility protocol, the doctor may actually be injecting infectious cells into an area that can cause blood, organ, joint, muscle, or tendon infections. Not all cells will be viable depending on the processing procedure used and fat stem cell proliferation and differentiation is decreased in patients with increasing age, body mass index, diabetes mellitus and exposure to radiotherapy and Tamoxifen. It is this type of stem cell procedure that has resulting in infections of the spine and permanent blindness.  Our suggestion is to avoid this stem cell procedure. 

 

BONE MARROW DERIVED ADULT STEM CELLS - In this procedure, a large diameter needle is placed through the skin over the back of the iliac crest above the hip and drilled into the bone marrow itself.  Bone marrow is then aspirated out and stromal mesenchymal stem cells (what few there are) are obtained by washing the cells and filtering the cells.  There are far fewer mesenchymal stem cells in this concoction than there are in fat tissue, approximately 1/400th the number.  Just as with fat stem cells these bone marrow derived stem cells are not pure, mixed with bone spicules, hematopoietic stem cells (cells that make blood), and cellular debris- a combination that is not optimal for injecting into certain organs, joints or tendons. Because this has been shown to be ineffective in some knee and joint pain, it is recommended to avoid this procedure using bone marrow derived stem cells since they cannot be concentrated or purified or expanded in the US

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COMBINED BONE AND FAT STEM CELLS AND PRP - This procedure is throwing everything you have at a problem at the same time.  There is little evidence this works better than fat stem cells alone, but because all three procedures involve penetrating the skin, the risk of infection is higher.  Life threatening spinal infections have resulted from combining everything possible into an injection without scientific or medical evidence that the combination works any better than single technique therapies. 

 

AMNIOTIC STEM CELLS - these are of two types, viable and non-viable, that are obtained from the amniotic membrane of the placenta upon birth.  The cells are generally non-allogenic: that is , they do not evoke an allergic response or rejection from the adult human body.  Unfortunately, this was the cell type involved in a giant scam for many years when non-viable cells (dead) were injected by orthopedic surgeons, pain physicians, physiatrists, and others into shoulder and knee joints, and the patients were being told they were receiving stem cells.  Since none of the stem cells were alive, the long term response was essentially nothing.  Patients were NOT receiving live stem cells, thus the scam perpetuated by these doctors at a cost of $2,000-$5,000 each treatment.  Many doctors made a fortune off of patients who were fleeced by this scam, and continue operating today.  Only since 2016 has there been available viable (live) amniotic stem cells, and they coexist along side the non-viable stem cells that continue to be injected as a scam.  Because of the controversy surrounding this type of stem cell, we suggest avoiding this type of stem cell to eliminate being the victim of a scam by unscrupulous doctors. 

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UMBILICAL STEM CELLS - These stem cells are derived from the umbilical cord, are viable, and non-allergenic. They are also purified, concentrated, and sterile, something not achievable with fat or bone derived stem cells. There is some scientific evidence these are superior. This is the type of stem cell used by Algos.  We offer these stem cells at OUR COST unlike all other doctors in Tampa Bay.  For 6,000,000 stem cells our cost is 1/3 to 1/20 what other doctors charge for stem cell treatments.  

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STEM CELL TREATMENTS WITH SCIENTIFIC EVIDENCE OF EFFECT

Systematic Reviews

KNEE OSTEOARTHRITIS   Six trials with high risk of bias showed level-3 or level-4 evidence in favour of stem cell injection (https://www.ncbi.nlm.nih.gov/pubmed/28258177). 

Review of bone marrow aspirates for knee osteoarthritis: Eleven studies were considered. Of these, 5 were prospective studies, 1 was a retrospective study, 2 were case series, and 3 were case reports. Three comparative studies (2 with level 2 evidence, 1 with level 3 evidence) were found in our search; none of them were randomized. Three studies investigated the clinical efficacy of BMAC in the treatment of osteoarthritis, and 8 studies evaluated the efficacy of BMAC on focal cartilage injuries. All 3 studies regarding osteoarthritis and all 8 studies regarding focal chondral defects reported good to excellent overall outcomes with the use of BMAC.

CONCLUSION:Although a growing interest for biological alternatives of treating knee pathology has been observed in the past few years, there still remains a paucity of high-quality studies. The studies included in this systematic review reported varying degrees of beneficial results with the use of BMAC with and without an additional procedure for the treatment of chondral defects and early stages of osteoarthritis. Most articles present the use of BMAC as a safe procedure and report good results.(https://www.ncbi.nlm.nih.gov/pubmed/26798765)

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In conclusion, assessment of the comprehensive evaluation index indicated that there were no significant differences after stem cell treatment. However, assessment of clinical symptoms and cartilage morphology showed significant improvement after stem celltreatment. (https://www.ncbi.nlm.nih.gov/pubmed/26122717)

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MSCs injection could be potentially efficacious for decreasing pain and may improve physical function in patients with knee OA. The findings of this review should be confirmed using methodologically rigorous and adequately powered clinical trials (https://www.ncbi.nlm.nih.gov/pubmed/25944079)

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TENDON REPAIR  No evidence (level 4) was found for the therapeutic use of stem cells for tendon disorders. (https://www.ncbi.nlm.nih.gov/pubmed/28077355)

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LIMB ISCHEMIA  Metaanalysis

RESULTS:Ten studies bone marrow aspirates, totaling 499 patients, were included in this meta-analysis. No significant differences were observed in major amputation rates (relative risk [RR] 0.91; 95% confidence interval [CI] 0.65-1.27), survival (RR 1.00; 95% CI 0.95-1.06), and amputation free survival (RR 1.03; 95% CI 0.86-1.23) between the cell treated and placebo treated patients. The ankle brachial index (mean difference 0.11; 95% CI 0.07-0.16), transcutaneous oxygen measurements (mean difference 11.88; 95% CI 2.73-21.02), and pain score (mean difference -0.72; 95% CI -1.37 to -0.07) were significantly better in the treatment group than in the placebo group.

CONCLUSIONS:This meta-analysis of placebo controlled trials showed no advantage of stem cell therapy on the primary outcome measures of amputation, survival, and amputation free survival in patients with CLI. The potential benefit of more sophisticated cell based strategies should be explored in future randomized placebo controlled trials. (https://www.ncbi.nlm.nih.gov/pubmed/26460286)

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OSTEONECROSIS OF THE FEMORAL HEAD:  Our findings suggest that implantation of autologous mesenchymal stem cells (MSCs) into the core decompression track, particularly when employed at early (pre-collapse) stages of ONFH, would improve the survivorship of femoral heads and reduce the need for hip arthroplasty. (https://www.ncbi.nlm.nih.gov/pubmed/26220203)