How real is
Stem Cell Treatment for Chronic Wounds?
We are witnessing the change in medical treatment of the 21 century from treating symptoms with chemical and biological drugs to regeneration, potentially curing via most promising experimental Stem Cells, Gene, Bio-printing and Pulsed Electromagnetic Energy Technology.
Wound healing requires a coordinated interplay among cells, growth factors, and extracellular matrix proteins. Central to this process is the endogenous mesenchymal stem cell (MSC), which coordinates the repair response by recruiting other host cells and secreting growth factors and matrix proteins.
Unlike pharmaceutical treatments, that deliver a single agent at a specific dose, Mesenchymal stem cells (MSCs) are site regulated and secrete bioactive factors and signals at variable concentrations in response to local micro-environmental cues.
MSCs are self-renewing multipotent stem cells that can differentiate into various lineages of mesenchymal origin such as bone, cartilage, tendon, and fat. Significant progress has been made in understanding the biochemical and metabolic mechanisms and feedback associated with MSC response. In addition to multi-lineage differentiation capacity, MSCs regulate immune response and inflammation and possess powerful tissue protective and reparative mechanisms, making these cells attractive for treatment of different diseases.
The beneficial effect of exogenous MSCs on wound healing was observed in a variety of animal models and in reported clinical cases. Specifically, they have been successfully used to treat chronic wounds and stimulate stalled healing processes.
In our review we noticed that on 2. November 2014, 3228 clinical trials with the subject “Wound Healing” had been registered and 214, i.e. about 6.6 % are stem cell related trials.
The majority (93,4 %) of the 3228 clinical trials for wound healing is as mentioned before, based on traditional chemical and biological drug treatment, only 214 stem cell treatment had been recorded in the official government statistic on 2. Nov. 2014.
We need to understand that clinical trials for chemical and biological related drugs are taking ten (10) plus years and a lot of money by the investigating company before they reach the market. This, maybe is the main reasons that most clinical trials are still done in the traditional field of medicine, although 214 stem cell trials are showing a clear and high interest in new treatment methods.
Allogeneic Stem Cells and wound healing.
Allogeneic MSC treatments, had been categorized as a drug by regulatory agencies. This is a treatment method where third party stem cells from bone marrow, placenta, cord blood, peripheral blood, or adipose tissue is harvested, expanded in a lab and supplied after being approved by FDA / EMA via clinical trials, to the market as “stem cell treatment in a bottle” ready to use via a physician.
As mentioned above wound healing is a major research activity with 3228 registered clinical trials. 214, i.e. about 6.6 % are stem cell related trials. Out of the 214 registered clinical trials, related to stem cell treatment; 39 (18,2 %) are with allogeneic stem cells. 29 trials are using bone marrow and 1 trial placenta derived stem cells some of them also combine manipulated genes with those harvested stem cells.
Autologous Stem Cells and wound healing
This is a treatment method where own stem cells harvested from bone marrow, placenta, cord blood, peripheral blood, or adipose tissue. This kind of stem cells if expanded in a lab, i.e. more than minimal manipulated, can only be used in human treatments after being approved by FDA / EMA via clinical trials, to the market as “stem cell treatment in a bottle” ready to use via a physician.
We found 83 (38,7 %) clinical trial of the 214 registered trials are reviewing autologous stem cell treatments, countries involved see beside. Out of this 83 autologous stem cell trials, 5 are with adipose tissues.
From our market review we could see, that many international clinics already doing IRB approved or even non IRB approved (some non-western Countries) experimental studies not registered in the clinical trial statistic of the US government.
An IRB approved patient funded study is often done in well recognized international clinics with qualified physicians and clinical environment, following up experimental therapies in the frame of “Practice of Medicine and the Declaration of Helsinki”, i.e. the treatment is done as a “same day surgical procedure” in the responsibility of the surgeon not considered as a drug treatment.
The advantage of using autologous stem cells from adipose (fat) tissues and its stromal vascular fraction (SVF) is that it can easily be harvest via a mini liposuction. This mixture is minimal manipulated , non-expanded and re-injected via intravenous injections (IV) into the blood stream, or via direct injection, or by guided imaging directly at the treatment site, for example in a chronic wound. All it takes is a 3 to 4 hour medical procedure in a qualified out-patient clinic set up.
This method is obviously more recently favoured by some treating physicians and even by patients, although it is experimental, as SVF from fat is rich in stem cells and contains about 500 times more stem cells than those same quantity harvested from a more painful bone marrow extraction. Furthermore there are various studies showing that the treatment with non-expanded own stem cells is safe, especially not having any immune reaction as they are deriving from the same body.s stem cells,
Link about safety of autologous stem cells:
Over the past decade, international research efforts have established a wealth of basic science and preclinical evidence regarding the differentiation potential and regenerative properties of freshly processed stromal vascular fraction.
The stage has been set for clinicians to translate stem cells from the bench to the bedside and certain clinics are key contributors to get this procedure out of the laboratories and to the patients who are looking for alternatives to their unmet medical need.
Already in 2011, Bioheart, Inc., USA announced positive efficacy data from the registry study of bone marrow and adipose derived stem cells for the treatment of end stage critical limb ischemia with wounds. Vaclav Prochazka MD, PhD, MSc., of University Hospital Ostrava, Czech Republic presented data at the American Academy of Anti-Aging Medicine Conference in Las Vegas in Dec. 2010 The study focuses on end stage patients with severe wounds.
Endpoints include elimination of major amputation risk, ankle brachial index, toe pressure, transcutaneous oxygen pressure, and quality of life. Dr. Prochazka presented results of a clinical study with bone marrow derived cells and preliminary follow up of the adipose registry study. Seventy-five percent of patients presented with healing and pain reduction while only twenty-five percent of the patients required major limb amputation due to disease progression. Autologous adult bone marrow derived stem cells (BMSCs) and adipose tissue derived stem cells (ADSCs) can help to produce angiogenesis or formation of new blood vessels as well as assist in the healing process. There were no reported deaths or severe adverse events demonstrating the safety of the products.
In this connection we also like to mention that harvesting stem cells and growth factors from peripheral blood and using PRP for wound healing has produced amazing results.
Very clear “Hope for some treatments with stem cells, like wound healing is already Real” although stem cell treatment in general is still experimental.
Please note that we have to mention our legal statement that all those information provided are for educational purpose only and those treatment results with stem cells are personalized from individual case studies only, not guaranteeing that the result can be always reproduced.
In case of doubts or questions please consult your trusted physician.