Stem Cell Therapy: Update and Clinical Trials 2020

Due to the fast-changing pace of research and technology, new evidence related to stem cell therapy accumulates rapidly and clinical guidelines need to be periodically updated.

If you are new to stem cells, check out stem cell basics.

We have compiled and summarised essential information below in layman's terms so that you can understand and make a better informed decision.



Trying to keep up with the latest stem cell therapy evidence?

Just on UC-MSC (umbilical cord derived mesenchymal stem cells) alone, there was 178 registered clinical trials and 98 publications about cell therapy that employ UC-MSC, for the years 2007–2017.

This page contains information and links to list of stem cell therapy and research in various categories. This list is a work-in-progress list as new evidence might be added from time to time.


Stem Cell Therapy and Stem Cell Therapy Research

Here, we have listed and compiled all significant scientific publications related to stem cell therapy. The list was complied by running various searches on PubMed.

In order to make it consumer friendly, we have tried to summarise the studies and minimise the technical jargons.

Here is the list by category.

1) Stem Cell Therapy for Knee Pain (knee osteoarthritis)

Some doctors and media channels argue that there is very little evidence to support the use of stem cells to treat orthopaedic conditions. However, there are more than 200 studies related to the use of stem cells in treating orthopaedic conditions. 

Here, we have compiled a few significant studies related to stem cell therapy for knee pain.

In 2016, a study on knee osteoarthritis has shown a 25 million of adult human bone marrow, allogeneic (source from different individuals) mesenchymal stromal cells to be the most effective dose tested for knee joint pain reduction.

study published in 2012 by a team in Singapore, led by Dr Lee KB showed injections of mesenchymal stem cells with hyaluronic acid for knee joint repair (new technique) to be comparable with the conventional technique but with the advantage of being less invasive.

In 2013, a team led by Dr Saw from Malaysia published a controlled study of 50 patients with knee pain treated with autologous (source from self) peripheral blood stem cells (PBSC) sowed better improvement as compared to the group without stem cells.

In 2016, a 9 year follow up study of 2,372 patients in 18 clinical facilities was published by Centeno et al. Treated areas of the body included the knee, hip, ankle/foot, hand/wrist, elbow, shoulder, and spine. There was no evidence to suggest that treatment with mesenchymal stem cells (MSCs) of any type in this study increased the risk of cancer.

Conclusion

Several other comparative studies have demonstrated good evidence in the treatment of osteoarthritis. However, there are several approaches and cell lines used. More well-designed and randomised controlled trials are needed to evaluate the best approach and universal consensus. As studies continue, the methods, forms and combinations of stem cell preparations are improving, and outcomes are expected to improve as well.



Majority of stem cell research for diabetes is concentrated on Type 1 diabetes as it can be traced to the loss of a single cell type, the beta islet cell. Beta cells (β cells) are a type of cell found in pancreatic islets that produce and secrete insulin. In patients with type I or type II diabetes, beta-cell mass and function are diminished, leading to insufficient insulin secretion and high blood sugar.

Currently, two approaches are being used in research, using stem cells as beta-cell producing factories or as a beta cell repair catalyst. Both methods have the same goal which is to return the insulin to normal levels. Diabetes Research Institute (DRI) are running clinical trials and have a number of patients that are living insulin free after receiving a transplant of donor islet cells.

There are many ongoing efforts to understand how stem cell therapy is able to help people with diabetes. One of the main centres is the California Institute of Regenerative Medicine, where you can view the areas of research being conducted specifically to understand diabetes.

A review, published in the Progress in Stem Cell journal in 2019 suggested a combination of antioxidants, growth factors or hormones along with MSCs (mesenchymal stem cells) in optimal combinations and concentrations for the treatment of diabetic nephropathy.


3) Stem Cell Hair Treatment

MSCs (mesenchymal stem cells) have recently emerged as a new therapeutic option for hair loss.

2017 study by researchers at Rome University found that 23 weeks after treatment, hair density had improved by a third.

According to Dr Ioannis Liakas, who performs the stem-cell procedure at his London clinic, Vie Aesthetics, it has the potential to not just restore growth but even colour in grey hair.


4) Stem Cell Therapy for Autism

Stem cell therapy for autism is an ongoing topic of research and is considered experimental by the medical community. Parents can find fee-for-service clinics that advertise stem cell therapy for autism, but most of these clinics are operating without FDA approval, and each clinic promotes their own approach, which creates a lot of confusion among parents about how to compare their treatment options.

Clinical trials have been performed to demonstrate safety and efficacy of stem cells autism management:

Sharma A, Gokulchandran N, Sane H, et al. Autologous bone marrow mononuclear cell therapy for autism: an open label proof of concept study. Stem Cells Int. 2013;2013:623875. [PMC free article]

Dawson G, Sun JM, Davlantis KS, et al. Autologous cord blood infusions are safe and feasible in young children with autism spectrum disorder: results of a single-center Phase I open-label trial. Stem Cells Transl Med. 2017;6(5):1332–1339. [PMC free article]

The list below is a summary of stem cell clinical trials for autism so far, restricted only to trials in North America and to trials using either cord blood Mono Nuclear Cells (abbreviated CB-MNC) or cord tissue Mesenchymal Stromal Cells (abbreviated UC-MSC).

Autologous Cord Blood Stem Cells for Autism
Cell Type and source: Own CB-MNC 
Cell dose (millions): 16 M/kg

Allogeneic Umbilical Cord Mesenchymal Stem Cell Therapy for Autism
Cell Type and source: Donor UC-MSC
Cell dose (millions): 0.5M/kg - 1M/kg

hCT-MSCs for Children With Autism Spectrum Disorder (ASD) (hCT-MSCs)
Cell Type and source: Donor UC-MSC
Cell dose (millions): 2M/kg - 6M/kg
hCT-MSCs are a product of allogeneic cells manufactured from digested umbilical cord tissue that is expanded in culture, cryopreserved and banked.


5) Stem Cell Therapy for Stroke

To date, no cell therapy products for stroke are yet on the market. In this review (published in Nature), the authors examined the clinical research trends related to stem cell therapy products in the stroke space based on information obtained from the ClinicalTrials.gov website and International Clinical Trials Research Platform (ICTRP) portal site.


6) Stem Cell Therapy for Back Pain

Do take note that back pain problems may arise from several causes and degenerative disc is just one of the many causes of back pain. Therefore, the importance of finding out the cause first before treatment.

Stem Cell Clinical Trials for Back Pain and Degenerative Disc Disease - Update 2020

Clinical trials showing the effectiveness of Stem Cell Injections for Lower Back Pain. Most patients in these studies had significant pain relief. Some patients also revealed reversal of disc degeneration. No patients had any serious complications. Since stem cells are a new development in medicine, there is not an abundance of data. However, the data that exists shows that stem cell injections into the disc results in pain relief and improvement in function.

In this landmark study by Pettine’s group (published in 2016), 26 patients with lower back pain had their lumbar discs injected with stem cells which were extracted from the bone marrow. After 2 years, 21 patients (81%) avoided surgery and had pain reduction of 71%. Their function improved by 64%. Additionally, 40% patients had improvements seen on the follow up MRI’s. No complications were reported.

Centeno’s group followed 2372 patients (published in 2016) who had stem cell injections in various joints for 2.2 years. They reported no serious side effects.

Wu’s group performed a metaanalysis (published in 2018) of all the clinical studies regarding stem cells injection into discs and concluded that, Cell-based therapy is for patients who have discogenic low back pain associated with improved pain relief and Oswestry Disability Index.

Approximately 30 pre-clinical animal studies using stem cells to treat DDD (Degenerative Disc Disease) have been published, with many demonstrating positive outcomes and others reporting no or worsened effects.

There are 15 spinal cord pathology studies listed on www.clinicaltrials.gov with only two studies completed, four recruiting, four status-unknown, one suspended, two active-not-recruiting, one withdrawn and one terminated. Although some preliminary information has been obtained, much remains to be determined with respect to the best method of stem cell delivery, source of stem cell, numbers of cells to be delivered and the patient selection to receive such therapy. These considerations are common to all potential spine-related stem cell applications.

There are four FDA approved adipose derived stem cell clinical trials at Sanford Health: osteoarthritis of the knee, osteoarthritis of the wrist, rotator cuff tear, and facet joints.

There is a product currently in phase 3 clinical trials at the US Food and Drug Administration (FDA) called Mesoblast. If the results from that study are favourable, then we could have stem cells available for the treatment of degenerative disc disease very soon.

Another clinical trial that has just completed it's recruitment, studied Mesenchymal Precursor Cells (MPCs) in 100 Subjects With Lumbar Back Pain.

The iPSpine project, a pan-European clinical trial was awarded €15 million in 2019 under the Horizon 2020 programme, towards researching a solution for chronic lower back pain. The huge public-private consortium is comprised of 20 partners, and is coordinated by the Faculty of Veterinary Medicine of the Utrecht University (Netherlands).

The iPSpine consortium was formed to initiate a European-led research effort to identify a future advanced therapeutic strategy that can address the societal need for a radical new treatment of IDD-induced LBP (Intervertebral Disc Degeneration - induced Low Back Pain).

The aim of iPSpine is to investigate and develop a new advanced therapy medicinal product (ATMP) of the future, based on a novel developmental biology approach involving induced pluripotent stem cells (iPSC) and smart biomaterials.


7) Stem Cell Therapy for Anti-Aging Research Update

Stem cell therapy for anti aging is an ongoing topic of research and is considered experimental by the medical community. Is there any evidence that stem cell therapy for anti aging is effective and safe?
www.AestheticsAdvisor.com
Despite the fact that there are many published studies on stem cell therapy for anti-aging, major media has been slow to report the findings.

Journal of Gerontology - The results of 2 clinical studies, published in The Journals of Gerontology, showed how a type of adult stem cell called mesenchymal stem cells (MSCs) could reverse the effects of aging.

The first trial involved 15 frail patients, each received single MSC infusion of stem cells collected from adult bone marrow donors aged between 20 and 45 years old. The patients exhibited improved overall quality of life and fitness, as well as diminished tumor necrosis factor levels. The second trial was a double-blind, randomized study involving a placebo group. Aside from noting no adverse effects, the research team found the improvements to be “remarkable.”

We have compiled other related published studies below.

Yu Y. Application of Stem Cell Technology in Antiaging and Aging-Related Diseases. Adv Exp Med Biol. 2018;1086:255-265

Ivonne Hernandez Schulman, Wayne Balkan and Joshua M. Hare. Mesenchymal Stem Cell Therapy for Aging Frailty. Front Nutr. 2018; 5: 108.

Juan Antonio Fafián-Labora, Miriam Morente-López, and María C Arufe. Effect of aging on behaviour of mesenchymal stem cells. World J Stem Cells. 2019 Jun 26; 11(6): 337–346.


8. Stem Cell Therapy for Kidney Diseases

The increasing incidence of kidney diseases raises considerable concerns regarding human health worldwide. A number of studies in recent years have attempted to identify the underlying mechanisms of renal repair in order to explore the potential regenerative capacity of the kidneys. Many papers have reported on the potential use of stem cells of different origins for treating many different pathologies, including kidney diseases.

Several clinical trials have confirmed the safety and tolerability of stem cells, and in particular of MSC-based therapies (Mesenchymal Stem Cell), in patients with renal diseases and kidney transplants (Int J of Mol Sci. 2019). There are currently more than 30 studies on stem cell treatment for kidney diseases under the U.S. Clinical Trial Registry.


9. Stem Cell Therapy for Liver Diseases

Liver failure caused by liver cirrhosis, due to various long term liver diseases such as chronic hepatitis B and non-alcoholic fatty liver disease; was thought to be irreversible. A liver transplant is currently the standard treatment to end-stage liver cirrhosis.

However, not every liver failure and liver cirrhosis patients are eligible for a liver transplant in Malaysia. The shortage of matching donors and the high risk of surgical-associated complications further limits the success of a liver transplant.

Since stem cells can be transformed into liver-like cells, the potential of stem cell therapy to treat liver failure and liver cirrhosis has been studied as an interesting new feasible option.

A review of 37 studies (Int Journal of Stem Cell Res and Ther. 2017) by Malaysian researchers found that both autologous and allogeneic adult stem cell-based therapies have shown promising results in restoring liver function in cirrhosis patients.


10) Stem Cell Therapy for Other Indications

The public may search a database of NIH-sponsored clinical trials at www.clinicaltrials.gov. Enter the search terms of interest (e.g., Parkinson's Disease and stem cells) to search for applicable clinical trials.

For a list of diseases that can be treated with stem cell therapy, check out Listing of Diseases that can be treated with Stem Cell Therapy.


Wrapping It Up

If there are any new major stem cell related evidence that we’ve missed, please let us know in the comments and we’ll add them to the post! Thank you in advance.

> To find stem cell therapy clinics in Malaysia, check out Stem Cell Therapy Clinics in Malaysia.

Read more > Stem Cell

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