Injectable Amniotic Membrane/Umbilical Cord Particulate for Knee Osteoarthritis: A Prospective, Single-Center Pilot Study

Castellanos, Ramon; Tighe, Sean

doi:10.1093/pm/pnz143

Cited by 40 publications

(44 citation statements)

References 55 publications

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“…[ 21 ] Pre-clinical and clinical studies have confirmed these therapeutic benefits in diseased joints where particulate AMUC attenuated progressive cartilage degeneration and provided pain relief of symptomatic knee OA. [ 12 , 13 ] Considering that the knee and facet share similar anatomical features and osteoarthritic changes have been a universal finding in facet degeneration, [ 4 ] it is not surprising the current case series show similar therapeutic effects as previously seen in those studies.…”

Section: Discussionsupporting

confidence: 70%

“…This dose was recently shown to attenuate pain in knee OA. [ 13 ] A total of 0.4 mL was injected into the zygapophysial intra-articular space while 0.1 mL was injected around the inferior capsule area. Patients were allowed to return immediately to normal activities.…”

Section: Methodsmentioning

confidence: 99%

“…For example, intra-articular injection of particulate AMUC has been shown to improve pain in symptomatic knee osteoarthritis (OA), and to prevent cartilage destruction in a rodent model of induced OA. [ 12 , 13 ]…”

Section: Introductionmentioning

confidence: 99%

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Cryopreserved amniotic membrane and umbilical cord particulate for managing pain caused by facet joint syndrome

Bennett¹

2019

Medicine

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Treatment of back pain due to facet joint syndrome has been a challenge for physicians since its recognition ∼80 years ago. Intra-articular injections of steroids, local anesthetics, and phenol have been widely adopted despite their known shortcomings. Recently, intra-articular injection of amniotic membrane-umbilical cord (AMUC) has been utilized in various orthopedic indications, including those involving synovial joints, due to its reported anti-inflammatory properties. Herein, use of AMUC for facet joint syndrome was evaluated.A single-center case series was conducted on patients presenting with pain caused by facet joint syndrome, confirmed by single blocking anesthetic injection and treated using a single intra-articular injection of 50 mg particulate AMUC (CLARIX FLO) suspended in preservative-free saline. Patient reported back pain severity (numerical scale 0–10) and opioid use were compared between baseline and 6 months following treatment.A total of 9 patients (7 males, 2 females), average age 52.1 ± 15.9 years, were included. Five patients with cervical pain had a history of trauma, 1 patient had suffered lumbar facet injury and 3 had degenerative lumbar facet osteoarthritis. All patients had severe pain prior to injection (8.2 ± 0.8) and 4 (44%) were taking opioids (>100 morphine milligram equivalents). Six-month post-treatment, average pain had decreased to 0.4 ± 0.7 (P <.05). All patients had ceased use of prescription pain medications, including opioids. No adverse events, repeat procedures, or complications were reported.Intra-articular injection of AMUC appears to be promising for managing facet pain and mitigating opioid use. Further investigation with larger sample size is warranted.

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Section: Discussionsupporting

confidence: 70%

Section: Methodsmentioning

confidence: 99%

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Cryopreserved amniotic membrane and umbilical cord particulate for managing pain caused by facet joint syndrome

Bennett¹

2019

Medicine

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“…Subjects who received ASA injections demonstrated superior efficacy in measures of pain and function at 3 and 6 months post-treatment 43 . In a separate study, a noted reduction in pain at 6 months post-injection was reported for 20 OA patients that were treated with an IA injection of morselized amniotic membrane/umbilical cord tissue 44 . Importantly, no serious, unanticipated, product-related adverse Several commercial formulations containing placental tissue particulates have been marketed as HCT/P's regulated by the FDA under section 361 of the PHS act and 21 CRF part 1,271.…”

Section: Discussionmentioning

confidence: 89%

A novel placental tissue biologic, PTP-001, inhibits inflammatory and catabolic responses in vitro and prevents pain and cartilage degeneration in a rat model of osteoarthritis

Flannery

Seaman

Buddin

et al. 2021

Osteoarthritis and Cartilage

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Objective: Characterization of a novel human placental tissue-derived biologic, PTP-001, which is in development as a candidate therapeutic for the treatment of osteoarthritis symptoms and pathophysiology. Methods: Human placental tissues from healthy donors were prepared as a particulate formulation, PTP-001. PTP-001 extracts were assayed for the presence of disease-relevant biofactors which could have beneficial effects in treating osteoarthritis. PTP-001 eluates were tested in human chondrocyte cultures to determine effects on the production of a key collagen-degrading matrix metalloproteinase, MMP-13. PTP-001 eluates were also assessed for anti-inflammatory potential in human monocyte/macrophage cultures, as well as for growth-stimulating anabolic effects in human synoviocytes. The in vivo effects of PTP-001 on joint pain and histopathology were evaluated in a rat model of osteoarthritis induced surgically by destabilization of the medial meniscus. Results: PTP-001 was found to contain an array of beneficial growth factors, cytokines and anti-inflammatory molecules. PTP-001 eluates dose-dependently inhibited the production of chondrocyte MMP-13, and the secretion of proinflammatory cytokines from monocyte/macrophage cultures. PTP-001 eluates also promoted proliferation of cultured synovial cells. In a rat osteoarthritis model, PTP-001 significantly reduced pain responses throughout 6 weeks post-dosing. The magnitude and duration of pain reduction following a single intraarticular treatment with PTP-001 was comparable to that observed for animals treated with a corticosteroid (active control). For rats dosed twice with PTP-001, significant reductions in cartilage histopathology scores were observed. Conclusions: PTP-001 represents a promising biologic treatment for osteoarthritis, with a multi-modal mechanism of action that may contribute to symptom management and disease modification.

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“…A recent prospective pilot study further demonstrated that one or two injections of 50 mg AM/UC particulate significantly improved pain and physical function in mild knee OA for up to 6 months. 20 Given these encouraging findings, we conducted a retrospective study to assess the clinical benefit of a single intra-articular injection of 100 mg AM/UC particulate in alleviating pain and promoting functional recovery in patients with moderate-to-severe knee OA.…”

Section: Introductionmentioning

confidence: 99%

<p>Intra-Articular Injection of Amniotic Membrane and Umbilical Cord Particulate for the Management of Moderate to Severe Knee Osteoarthritis</p>

Mead¹,

Mead²

2020

ORR

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Objective: To evaluate the long-term benefit of a single injection of amniotic membrane/ umbilical cord (AM/UC) particulate in patients with moderate to severe knee osteoarthritis (OA). Methods: A single-center, investigator-initiated, retrospective study of patients who received intra-articular injection of 100 mg lyophilized and micronized AM/UC for radiographically confirmed, Kellgren-Lawrence (KL) grade 3 or 4 symptomatic knee OA. Data regarding demographics, OA severity, comorbidities, treatment regimens, complications, and patient-reported outcomes were collected and assessed. Patient Global Impression of Change (PGIC) was assessed on a 7-point scale, and Global Perceived Improvement (GPI), expressed as percent improvement relative to baseline, was used to further quantify the degree of symptomatic change. Clinically important response to treatment was assessed at 12 months using simplified OMERACT-OARSI responder criteria. Results: A total of 42 patients with KL grade 3 (36%) and 4 (64%) knee OA were included for analysis. Prior to injection, patient-rated pain was 6.6 ± 1.5 out of 10 (median: 7, range: 3-10) despite prior treatment with oral/topical NSAIDs (62%) and intra-articular injection(s) of corticosteroids (57%) and/or hyaluronic acid (48%). Twelve months following AM/UC injection, 31 patients (74%) reported significant clinical improvement via PGIC, and the OMERACT-OARSI treatment response rate was 81% (34/42). GPI of pain and function was 62 ± 24%, 69 ± 27%, 69 ± 27%, and 64 ± 31% at 1, 3, 6, and 12 months, respectively. Symptomatic improvement was maintained for an average duration of 12.1 ± 4.5 months (median: 12, range: 3-22). One patient developed swelling in the knee within 36 hours of injection. No other adverse events or complications were reported. Conclusion: Intra-articular injection of AM/UC particulate may be effective in alleviating pain and improving function in patients with moderate to severe knee OA, with the potential to delay total knee replacement for up to 12 months.

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Injectable Amniotic Membrane/Umbilical Cord Particulate for Knee Osteoarthritis: A Prospective, Single-Center Pilot Study

Cited by 40 publications

References 55 publications

Cryopreserved amniotic membrane and umbilical cord particulate for managing pain caused by facet joint syndrome

Cryopreserved amniotic membrane and umbilical cord particulate for managing pain caused by facet joint syndrome

A novel placental tissue biologic, PTP-001, inhibits inflammatory and catabolic responses in vitro and prevents pain and cartilage degeneration in a rat model of osteoarthritis

<p>Intra-Articular Injection of Amniotic Membrane and Umbilical Cord Particulate for the Management of Moderate to Severe Knee Osteoarthritis</p>

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