The second phase of a clinical trial for patients to regain their sense of taste and smell is about to begin, and it is showing promising results.
Otolaryngologist Dr. David Rosen has been helping patients restore their sense of taste and smell after respiratory infections for two decades. When the COVID-19 pandemic hit, a concerning number of people were experiencing this overwhelming side effect. Traditional therapy to treat this condition can require a painful injection directly up the nostril to the olfactory nerve. But, Dr. Rosen began trying a less invasive treatment using a topical application of platelet-rich plasma (PRP) into the nose to stimulate cell regrowth and restore taste and smell. This therapeutic approach, which shows some success, is now entering into phase II clinical trial. Nancy, a patient suffering from persistent anosmia after a COVID diagnosis in 2021, shared how this trial has helped her senses begin to return.
We spoke with Dr. Rosen and otolaryngologists, Drs. Glen D’Souza and Alexander Duffy, about how the clinical trial is helping patients.
How is COVID causing loss of taste and smell?
Rosen: COVID is directly binding to the lining of the nose through a particular receptor called the ACE-2 receptor. The nose lining gets damaged, along with the cells it supports called the olfactory cells, commonly known as the smell cells. Because they lose the supporting cells, the olfactory cells can’t function properly.
How does treatment to regain taste and smell begin?
Rosen: First, we prescribe an oral steroid, work with patients through olfactory training (smell training), and suggest they begin taking supplements, such as V vitamin A, alpha-lipoic acid, sodium citrate, or omega 3. They can also use an over-the-counter nasal steroid. If they don’t recover within six months, we start trying more aggressive treatments, such as the one used in our clinical trial.
Can you tell us more about the treatment offered in the clinical trial?
Rosen: We are taking a patient’s blood and spinning it down to remove the red cells and saving the plasma, which has all the platelets in it. We take the PRP, and we apply that topically into the nose. This helps the cells regenerate because PRP can help cell regeneration throughout the body, for example, hair regrowth.
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Doctors Feel Hopeful About Restoring Taste and Smell Loss After COVID
Both in vitro and in vivo experiments have confirmed that platelet-rich plasma has therapeutic effects on many neuropathies, but its effects on carpal tunnel syndrome remain poorly understood. We aimed to investigate whether single injection of platelet-rich plasma can improve the clinical symptoms of carpal tunnel syndrome. Fourteen patients presenting with median nerve injury who had suffered from mild carpal tunnel syndrome for over 3 months were included in this study. Under ultrasound guidance, 1–2 mL of platelet-rich plasma was injected into the region around the median nerve at the proximal edge of the carpal tunnel. At 1 month after single injection of platelet-rich plasma, Visual Analogue Scale results showed that pain almost disappeared in eight patients and it was obviously alleviated in three patients. Simultaneously, the disabilities of the arm, shoulder and hand questionnaire showed that upper limb function was obviously improved. In addition, no ultrasonographic manifestation of the carpal tunnel syndrome was found in five patients during ultrasonographic measurement of the width of the median nerve. During 3-month follow-up, the pain was not greatly alleviated in three patients. These findings show very encouraging mid-term outcomes regarding use of platelet-rich plasma for the treatment of carpal tunnel syndrome.
Carpal tunnel syndrome (CTS) can be treated by both conservative (Klauser et al., 2009) and surgical interventions. Surgical decompression of the median nerve through the incision of the transverse carpal ligament (either open or mini-open or under ultrasound guidance) is the most cost-effective therapeutic option (Hui et al., 2005). However, mild to moderate CTS can be treated by conservative interventions, like functional braces and local infiltrations (Prime et al., 2010) in the carpal tunnel, mainly with corticosteroids. Local infiltration of corticosteroids easily leads to atrophy of the median nerve, subcutaneous fat, and systematic complications, such as hair loss and Cushing syndrome (Lambru et al., 2012). This treatment option is clearly inferior to surgical intervention despite the fact that it can improve clinical condition. There is evidence that local infiltration of corticosteroids is not superior to local injection of anesthetic (Karadas et al., 2012). To the best of our knowledgement, use of corticosteroids in the clinical practice has not been studied. However, a surgical treatment decision is always taken by the patient who sometimes wants to delay or avoid the surgery because of psychological or medical concerns including allergy to local anesthetic and immune deficiency and prefers a conservative treatment in the initial stage. A conservative treatment has been considered insufficient for CTS. In vitro and in vivo clinical and laboratory studies (Allampallam et al., 2000; Farrag et al., 2007; Cho et al., 2010; Anjayani et al., 2014; Park and Kwon, 2014) have demonstrated that platelet-rich plasma (PRP) has therapeutic action in several neuropathies. It would be interesting if a PPP injection is used as an alternative conservative treatment of CTS. The purpose of this study was to investigate if, and to what extent, a PPP injection, under ultrasound guidance, can improve the clinical condition of patients with CTS.
Materials and Methods
Fourteen patients were selected from initial 32 patients who received treatment in the Department of Orthopedics of “Konstantopouleio” General Hospital, Greece because of mild to moderate CTS, with a minimum of 3-month duration of symptoms, regardless of age and gender. Patients were rejected if they had one of the following items: thrombopenia, platelet dysfunction, local infection, NSAID use (less than 48 hours prior to injury), recent illness, malignancy, hemoglobin (Hb) level < 100 g/L, pregnancy, rheumatologic disease, uncontrolled hormonal disorder, vibrating caused neuropathy, systematic inflammatory disease, polyneuropathy, inability to complete questionnaires (due to language unawareness or mental disability), addicted to alcohol or drugs, total loss of sensation in the fingers, prior corticosteroid injection in the same wrist, had undergone a surgical intervention for CTS in the same hand, neurological deficit, cervical radiculopathy and/or cervical spinal stenosis and/or intervertebral disc herniation, nerve entrapment syndrome in the same hand.
PRP injection proved to be well tolerated, with no side effects, infections or complaints for persistent pain. We achieved well defined ultrasonographic mobilization, hydrodissection and hydrodisolution () of the compressed median nerve through PRP simple injection.
At the end of the first month after PRP injection, the mean reduction in VAS (%) was 48.6 mm out of 100 mm in comparison to rates prior to injection. At that time, we found eight patients with full or almost full recovery (VAS: 0 – 20 mm) and three patients with great improvement (VAS decline: more than 30 mm). The mean decline of the Q-DASH score was calculated just a little less than 70% compared to the pre-injection rates (from mean Q-DASH 56.42 prior to injection to mean Q-DASH17.5 one month after). These rates slightly more improved 3 months later ().
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Platelet-rich plasma (PRP) is a treatment that doctors use to accelerate healing in various areas of the body. It may help restore hair growth. Doctors typically use this treatment when hair loss results from androgenetic alopecia, a common condition that causes hair follicles to shrink. In males, this is called male pattern baldness. Although PRP is a relatively new approach, there is some scientific evidence to suggest that it can promote hair growth.
In this article, we describe how doctors use PRP to treat hair loss and what researchers say about its effectiveness.
To understand how PRP works, it is important to be aware of the role that platelets play in healing.
Platelets are a component of blood, along with red and white blood cells. When a person sustains a cut or wound, the platelets are some of the body’s “first responders” that arrive to stop the bleeding and promote healing. Researchers theorized that if they could extract concentrated platelets and inject them into damaged areas of the body, they could accelerate healing.
To produce PRP, a medical professional will take a blood sample and put it into a machine called a centrifuge. This machine spins at a rapid rate, which separates the components of the blood. The medical professional then extracts the platelets for injection. PRP contains a range of growth factors and proteins that speed tissue repair. As some types of hair loss result from damage to hair follicles, researchers initially hypothesized that PRP could help regrow hair by reversing the process that occurs in androgenetic alopecia.
Since then, PRP has become a popular method of restoring hair growth. Doctors have also used PRP to treat injuries to the tendons, muscles, and ligaments, such as those that people sustain during sporting activities.
In 2019, a team of researchers carried out a systematic review of the research on PRP as a treatment for hair loss. Their findings appear in the journal Aesthetic Plastic Surgery.
The analysis ultimately focused on 11 research papers that included a total of 262 participants with androgenetic alopecia. According to the authors, most of the studies found that injections of PRP reduced hair loss and increased the diameter of hairs and the density of hair growth. They acknowledged, however, that the treatment is controversial, noting that small sample sizes and low quality of research were among the limiting factors of their investigation.
Another 2019 systematic review, which featured in Dermatologic SurgeryTrusted Source, examined the findings of 19 studies investigating PRP as a treatment for hair loss. These studies recruited 460 people in total. According to the authors of the review, most studies reported that PRP treatments led to hair regrowth in those with androgenetic alopecia and alopecia areata. The authors of an additional review of clinical studies, which the International Journal of Women’s DermatologyTrusted Source published, considered PRP to be a “promising” treatment for hair loss, based on their findings. However, the team noted that because various researchers and clinics use different preparations, session intervals, and injection techniques to administer PRP, its effects can vary.
At this point, without a standardized protocol for injections, the authors explain, it is difficult to conclude that the treatment is effective.
The following steps are an example of a common approach to PRP injections for hair loss:
- A medical professional draws blood from a vein in the arm.
- They place the blood sample in a centrifuge.
- The centrifuge spins the blood, separating its components.
- A medical professional extracts the platelets using a syringe.
- A doctor injects the platelets into targeted areas of the scalp.
The entire process may take about 1 hour, and several sessions may be necessary. After receiving PRP treatment, a person can usually return to their regular activities without any limitations.
PRP is not a cure for conditions that cause hair loss. For this reason, a person would need to receive multiple PRP treatments over time to maintain hair growth results. The same is true of medications that doctors commonly use to treat androgenetic alopecia, such as topical minoxidil (Regaine) and oral finasteride (Propecia).
The doctor’s recommendations for how often a person should have PRP will vary depending on a person’s condition and the results of their initial treatment. The doctor may suggest having maintenance injections every 3–6 monthsTrusted Source once hair loss is under control.
At Miami Stem Cell we have treated hundreds of patients successfully for hair loss using PRP and/or Stem Cell Therapy. To learn more, contact Miami Stem Cell (305) 598-7777 to schedule a free evaluation to find out if PRP treatment is right for you. www.stemcellmia.com
Although chronic pain affects about 1% of the US population, it remains largely resistant to treatment. Despite great variability in pain outcomes, the application of autologous platelet-rich plasma (PRP) has become increasingly popular in attempts to reduce chronic pain. The variability in PRP efficacy raises the question of whether PRP actually has an analgesic capacity, and if so, can that capacity be made consistent and maximized. The best explanation for the variability in PRP analgesic efficacy is the failure during PRP preparation and application to take into account variables that can increase or eliminate its analgesic capabilities. This suggests that if the variables are reduced and controlled, a PRP preparation and application protocol can be developed leading to PRP inducing reliable, complete, and long-term pain relief. The goal of this study was to examine some of the variables that influence platelets and see how they might be controlled to increase the analgesic potential of PRP. Among the variables examined are the physiological status of the patient, methods used to prepare PRP, and methods of PRP application. The goal of modifying these variables is to minimize platelet serotonin content, maximize platelet content of factors that reduce inflammation and pain, while maintaining their bioactivity, maximize platelet capacity to aggregate at injury sites, induce rapid and simultaneous release of their contents, and optimize PRP application protocols. It is concluded that controlling some or many of these variables will lead to PRP that induces reliable, maximum, and long-term relief of chronic pain.
About 1% of the US population suffers from chronic pain that is often severely debilitating and largely resistant to treatment.1 Although chronic pain is a major public problem, there is little available effective pain management, and there is still a lack of understanding of the fundamental mechanisms of pain and how pain can be reliably and safely reduced or eliminated. This paper looks at the application of platelet-rich plasma (PRP) to pain sites as a potential technique for reducing or eliminating chronic pain, and the variables that must be addressed if PRP is to achieve its potential of providing some to complete and permanent relief of chronic pain.
Platelets within PRP release a host of pro- and anti-inflammatory mediators that not only induce pain but also reduce inflammation and pain. These factors also alter the wound environment leading to tissue healing and regeneration via the complex effects of regulating stem cell in-migration, proliferation, differentiation,2 and anabolic/catabolic processes.3 These multiple functions have led to the use of PRP to stimulate the recovery of nonhealing injuries, typically associated with chronic pain, in fields including ear, nose, and throat, orthopedics, sports medicine, dentistry, neurosurgery, ophthalmology, urology, wound healing, cosmetic, cardiothoracic, and maxillofacial surgery.4,5
A number of clinical studies concluded that PRP provides little or no pain relief for tendinosis6 or rotator cuff tears.6–8 However, other clinical studies found that PRP reduces or eliminates pain, such as that associated with tendinosis,9–11 rotator cuff tears,12,13 osteoarthritis,14 plantar fasciitis,15 and muscle injuries.16 PRP is also reported to act as an analgesic in animal pain models, such as rat tendinosis,17 rotator cuff injury,18 and dog tendon injury.19 In general, the findings of PRP analgesic influence led to the conclusion that although there are suggestions that PRP can act as an analgesic, the variability in study outcomes resulted from their small study sample sizes and the inclusion of too many variables, which did not allow the studies to be compared, or that the comparative analyses of the outcomes of different studies do not provide sufficient statistical support for the conclusion that PRP acts as an analgesic.4
Two major variables proposed to account for the observed differences in PRP efficacy are PRP composition, which differs greatly depending on the device used to prepare PRP, and the method of PRP application.20 This has led to the suggestion that consistent analgesic results will only be seen once the variables associated with PRP preparation and application are reduced.20–24
However, other variables must also be considered, each of which can exert significant influences on PRP composition and efficacy such as the: 1) physiological status of the individual from whom blood is drawn and on whom it will be applied; 2) platelet activation methods; and 3) types of tissues to which PRP is applied and injury type. These and other variables lead to >10-fold differences in platelet concentration within PRP, large differences in the type and concentration of factors within platelets, determine whether platelets aggregate and release their contents at the pain site, while also influences the concentration of factor released at the pain site, the rate of factor release, ratios of the released factors, and bioactivity levels of those factors. While any one variable can significantly alter PRP composition, multiple variables exert greater influences and can entirely block the analgesic efficacy of PRP.
One approach to developing a PRP preparation and application protocol that induces reliable, complete, and permanent pain relief is to determine the common variables associated with studies in which PRP induced good analgesia, and then perform new studies using those common variables. However, other variables that have so far not been considered must be taken into account, and adjusted to maximize the level of PRP-induced pain relief. This paper examines the influences of a number of the most salient variables associated with an individual’s physiological status, and methods for preparing and applying PRP, that affect the concentration of platelets in PRP, platelet factor content, concentration, bioactivity, and ratios, and how these variables can be adjusted to optimize the potential analgesic influence of PRP.
Keywords: analgesia, anti-inflammation, chronic pain, cytokines, inflammation, nerve trauma, neuropathic pain, platelet-rich plasma, pro-inflammation
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Clinical trial led by Thomas Jefferson University Hospital paves the way for innovative topical treatment
PHILADELPHIA – A minimally invasive treatment for individuals suffering from loss of smell and taste could become a reality. Led by Thomas Jefferson University Hospital otolaryngologist Dr. David Rosen, a team of physicians and researchers have developed a first-of-its-kind topical platelet-rich plasma treatment. Preliminary results from an ongoing clinical trial show promise in restoring patients’ sense of smell and taste.
Smell and taste disturbances known as anosmia and parosmia have grown in awareness in recent years since it is a common symptom of COVID-19. While the symptoms typically resolve for most individuals, up to 1.5 million people in the United States continue to experience long-term distortion of the sense of smell and taste.
Platelet-rich plasma (PRP) is a common restorative therapy used to regenerate cells, heal tissue, and address an array of medical conditions from healing injured muscles and tendons to increasing hair growth and reducing the appearance of scars. Animal studies have shown that PRP helps regenerate the olfactory epithelium, which may be the site affected in COVID-19 induced olfactory dysfunction (OD). As smell and taste are closely interrelated, improved sense of smell can help with sense of taste as well. Until now, PRP has been used as a nasal injectable in several small clinical trials for smell loss. Although the results were promising, nasal injections can be uncomfortable and invasive for patients.
“I’ve dedicated over two decades to helping patients recover from the loss of taste and smell,” said Dr. David Rosen, MD, Otolaryngologist, Thomas Jefferson University Hospital. “It was very important to me and our team to explore less invasive options as this issue has become increasingly prevalent due to COVID-19. The results of phase I of the clinical trial have been promising and we are looking forward to phase II to further improve the treatment.”
The new topical PRP treatment consists of monthly applications for a minimum of three months. A recent phase I clinical trial of eight patients who had at least six months of olfactory disturbance has shown preliminary success with 50 percent of participants experiencing clinically significant improvements in smell and taste. While phase I only consisted of eight patients, it is the largest pilot study to date for the use of PRP in treatment of OD and the first study to develop methods for topical delivery in human subjects. The new treatment has also been provided to dozens of additional patients independent of the phase I clinical trial with promising results.
A planned phase II study aims to exclusively look at patients who developed long term olfactory disturbance following recovery from COVID-19 infection. This will help the research team better understand patient variables and the number of treatments required to maintain sustainable improvements in smell and taste.