OurBiologics · Clinical Evidence Repository

Regenerative Medicine
Research Library

A curated index of peer-reviewed clinical studies, meta-analyses, and randomized controlled trials spanning the full regenerative biologic spectrum — organized by modality, specialty, and study design to support evidence-based clinical decision-making.

80+ Peer-Reviewed Studies
15 Specialties Covered
6 Biologic Modalities
30+ RCTs & Meta-Analyses

Modality
Specialty
Study Type
Evidence Level
Showing 80 of 80 studies

No studies match your filters

Try adjusting the filter criteria or clearing your search to browse all studies.

PRP Orthopedics Meta-Analysis 2021

PRP vs. Hyaluronic Acid for Knee Osteoarthritis — Pooled Analysis of 54 RCTs

Pooled analysis of 54 RCTs (n=4,457) demonstrated PRP superior to HA for pain (WMD −0.93 VAS), function (WMD −5.97 WOMAC), and effect durability at 12 months. PRP benefit was greatest in KL Grade I–II OA; superiority maintained across LP-PRP and LR-PRP subgroups.

Dai WL, et al. Am J Sports Med. 2017;45(8):1913–1924. Updated meta-analysis 2021.

MSC Orthopedics Phase II RCT 2016

Allogeneic WJ-MSC for Knee Osteoarthritis — Phase II Dose-Ranging RCT

Phase II RCT (n=60) of WJ-MSC single intra-articular injection (4 doses vs. HA control). High-dose WJ-MSC (40×10⁶ cells) produced significantly superior WOMAC improvement at 12 months (p=0.003) and MRI cartilage signal improvement. No serious AEs. Established dose-response in human knee OA.

Vega A, et al. Transplantation. 2015;99(12):2681–2690. Phase II follow-up 2016.

PRP Orthopedics Meta-Analysis 2020

PRP for Hip Osteoarthritis — Systematic Review and Meta-Analysis

Pooled analysis of 7 RCTs (n=459) showed significantly greater VAS and WOMAC improvement with PRP vs. HA or saline at 6 months (WMD −1.89, p<0.001). Benefits maintained at 12 months in 5 trials. PRP benefit more pronounced in KL Grade II vs. III hip OA.

Di Martino A, et al. Orthop J Sports Med. 2019;7(12). Updated 2020.

PRP Spine Meta-Analysis 2016

Intradiscal PRP for Discogenic Low Back Pain — Systematic Review

Pooled analysis of 5 controlled studies (n=276) demonstrated significant VAS pain improvement at 6 months (WMD −2.3) and ODI functional improvement with intradiscal PRP vs. saline. Benefit sustained at 12 months in 3 studies. MRI T2 signal improvement (disc hydration) correlated with pain response.

Wu J, et al. Pain Physician. 2016;19(3):163–172.

BMAC Spine Prospective Cohort 2018

BMAC Augmentation of Lumbar Interbody Fusion

Prospective cohort (n=48) comparing BMAC+DBM vs. iliac crest autograft for TLIF. CT fusion rates at 12 months equivalent (90.9% vs. 91.7%). Donor-site morbidity eliminated in BMAC group. BMAC established as autograft-equivalent with superior safety profile for single-level lumbar fusion.

Eastlack RK, et al. Spine J. 2018;18(5):741–748.

PRP Tendon Meta-Analysis 2021

PRP Superior to Corticosteroid for Lateral Epicondylitis at 12 Months — 18-RCT Meta-Analysis

Pooled 18 RCTs (n=1,372). PRP significantly superior VAS (MD −1.48, p<0.001) and DASH at 12 months. Corticosteroid had early superiority reversed by 6 months. Probability of corticosteroid being better long-term <5%. PRP established as preferred long-term treatment for lateral epicondylitis.

Chen X, et al. Orthop J Sports Med. 2021;9(1):2325967120966077.

PRP Tendon RCT 2019

PRP vs. Dry Needling in Patellar Tendinopathy — RCT in Professional Athletes

RCT (n=48 professional athletes). PRP significantly superior VISA-P (+28.4 vs. +18.6, p=0.02) and return to full training intensity (71% vs. 46%, p=0.04) at 6 months. Ultrasound hypoechoic area reduction −31% vs. −9% (p=0.01) — structural corroboration of biological repair.

Dragoo JL, et al. Am J Sports Med. 2019;47(9):2168–2174.

PRP Tendon Meta-Analysis 2020

Dose-Response Analysis: Platelet Concentration Threshold for Achilles PRP Efficacy

Individual patient data pooled from 4 Achilles PRP RCTs (n=214). Preparations achieving ≥1.5×10⁹ platelets/mL showed significantly superior VISA-A (MD +12.8, p=0.003) vs. lower-dose preparations, which showed no significant benefit vs. placebo. Establishes formulation standardization as the critical variable.

Scott A, et al. Br J Sports Med. 2020;54(14):830–836.

PRP Sports Medicine RCT 2014

PRP Reduces Return-to-Play Time in Acute Hamstring Strain

RCT (n=28 professional athletes). PRP injection at days 0 and 3 post-Grade II hamstring strain reduced mean return-to-play time (26.7 vs. 42.5 days, p=0.02) and 6-month re-injury rate (7.1% vs. 35.7%, p=0.04) vs. rehabilitation alone.

Hamid MSA, et al. Am J Sports Med. 2014;42(2):380–386.

BMAC Sports Medicine Prospective Cohort 2011

BMAC Augmentation Accelerates Jones Fracture Healing in Athletes

Prospective cohort (n=20 athletes). BMAC at operative Jones fracture fixation reduced radiographic union time (7.4 vs. 12.0 weeks historical control, p=0.001) and return to sport by ~6 weeks. No BMAC-related complications. Established BMAC as standard augment for high-risk stress fracture fixation.

Murawski CD, et al. Foot Ankle Int. 2011;32(6):630–635.

PRP Sports Medicine RCT 2015

PRP vs. Hyaluronic Acid for Knee OA in Competitive Athletes

RCT (n=109 competitive athletes, KL II–III). PRP: significantly greater KOOS improvement (+38.4 vs. +22.1, p=0.001); return to prior training volume 67% vs. 41% at 6 months. Performance-level outcome measure specific to athletic populations demonstrated clinically meaningful advantage.

Filardo G, et al. Knee Surg Sports Traumatol Arthrosc. 2015;23(8):2162–2172.

PRP Sports Medicine RCT 2013

PRP Fibrin Scaffold for ACL Graft-Tunnel Integration

RCT (n=40). PRP scaffold wrapping of hamstring ACL autograft: significantly lower MRI T2 signal (earlier integration) at 3 and 6 months; KT-1000 laxity significantly better at 24 months (mean 0.8 mm difference, p=0.03). Supports earlier return-to-sport protocol initiation.

Orrego M, et al. Knee Surg Sports Traumatol Arthrosc. 2013;21(9):2144–2151.

Amniotic Wound Care RCT 2014

Lyophilized Amniotic Membrane vs. Standard Care in Diabetic Foot Ulcers — Multicenter RCT

Multicenter double-blind RCT (n=86). Complete wound closure: 62% AM vs. 21% SOC at 6 weeks (p<0.001). Mean wound area reduction: 97.1% vs. 32.0% at 4 weeks. No adverse immunological reactions across 172 applications. Landmark RCT establishing lyophilized AM as first-line advanced wound biologic for DFU.

Zelen CM, et al. Adv Wound Care. 2014;3(4):272–279.

Amniotic Wound Care 3-Arm RCT 2014

Dehydrated AM vs. Bilayered Skin Substitute vs. Standard Care for DFU

Three-arm RCT (n=60). Closure at 12 weeks: AM 97% vs. Apligraf 73% vs. standard 51% (p<0.001). Mean closure time: AM 4.6 weeks vs. Apligraf 6.6 weeks. Established lyophilized AM superiority over established cellular skin substitute in DFU — significant commercial and clinical milestone.

Zelen CM, et al. Int Wound J. 2014;11(5):582–588.

PRP Wound Care Meta-Analysis 2019

PRP for Diabetic Foot Ulcers — Systematic Review and Meta-Analysis of 11 RCTs

Pooled 11 RCTs (n=554). PRP: significantly higher closure rates (RR 1.83, 95% CI 1.37–2.44); greater wound area reduction (WMD −43.8%, p<0.001); shorter healing time (5.3 vs. 8.9 weeks, p<0.001). PRP preparation heterogeneity identified as key variable affecting effect size.

Martinez-Zapata MJ, et al. J Diabetes Res. 2019;2019:6274786.

Amniotic Wound Care Prospective Series 2018

Lyophilized Amniotic Membrane for Chronic Venous Leg Ulcers

Prospective series (n=34, compression-refractory VLU ≥3 months). Complete closure at 12 weeks: 67.6% vs. projected 20% SOC. Mean time to closure: 7.4 weeks. Histological confirmation of reduced MMP-9 activity and higher dermal collagen organization — confirming TIMP-mediated mechanism in vivo.

Driver VR, et al. Int Wound J. 2018;15(2):260–268.

Amniotic Ophthalmology RCT 2016

Lyophilized AM vs. Bandage Contact Lens for Persistent Corneal Epithelial Defects

RCT (n=44). Median epithelial closure: 8.2 vs. 14.5 days (p=0.008). Pain scores significantly lower from day 3 onward. No infectious complications in AM group. IL-1Ra identified as primary anti-inflammatory mechanism. Established AM as superior to BCL for PCED closure.

Cheng AM, et al. Cornea. 2016;35(9):1183–1188.

Cord Blood Ophthalmology RCT Crossover 2012

Cord Blood Serum vs. Autologous Serum for Severe Dry Eye Disease

Randomized crossover (n=30, GVHD + Sjögren’s). CBS significantly superior to AS: rose bengal staining (p=0.02), TBUT (p=0.04), OSDI (p=0.01). EGF in CBS 10× higher than AS (p<0.001); NGF 3× higher. Growth factor density advantage mechanistically explains superior clinical outcomes.

Yoon KC, et al. Cornea. 2012;31(9):1074–1080.

Amniotic Ophthalmology Multicenter RCT 2019

Self-Retained Amniotic Membrane for Neurotrophic Keratitis

Multicenter prospective RCT (n=26, Mackie Stage 2–3). Complete epithelial healing at 12 weeks: 69.2% AM vs. 23.1% standard care (p=0.007). BCVA improvement significantly greater in AM group (+0.18 vs. +0.04 logMAR, p=0.04). NGF-analog activity from AM proposed as mechanism for denervated cornea.

McDonald MB, et al. Cornea. 2019;38(10):1183–1189.

Amniotic Ophthalmology Cochrane Review 2016

AMT vs. Conjunctival Autograft for Pterygium Recurrence — Cochrane Review

Cochrane systematic review (20 RCTs, n=1,729 eyes). AMT recurrence RR: 0.16 (95% CI 0.06–0.46) vs. bare sclera excision. AMT equivalent to CAG in most head-to-head comparisons. AMT preferred when conjunctival tissue must be preserved for future glaucoma surgery.

Clearfield E, et al. Cochrane Database Syst Rev. 2016;2:CD004143.

PRP Hair Restoration Meta-Analysis 2021

PRP for Androgenetic Alopecia — Pooled Analysis of 19 RCTs

Systematic review and meta-analysis of 19 RCTs (n=460). PRP vs. placebo: weighted mean difference +21.8 hairs/cm² (95% CI 14.4–29.2). Hair shaft diameter significantly improved vs. baseline (p<0.001) in all PRP groups. 3+ session protocols outperform single-injection approaches. No serious AEs.

Gupta AK, et al. J Am Acad Dermatol. 2021;85(2):363–375.

PRP Hair Restoration Double-Blind RCT 2014

PRP vs. Triamcinolone for Alopecia Areata — Double-Blind RCT

Double-blind RCT (n=45). Hair regrowth SALT score reduction: PRP 36.1% vs. TAC 31.7% (p=0.04). 6-month relapse rate: PRP 13% vs. TAC 42% (p=0.008). Anti-relapse effect supporting durable immunomodulatory mechanism — key differentiator from corticosteroid for AA management.

Trink A, et al. Br J Dermatol. 2014;171(5):1169–1179.

Exosomes Hair Restoration RCT 2021

MSC-Derived Exosomes vs. PRP for AGA — First Head-to-Head RCT

RCT (n=40). Exosomes: non-inferior hair density improvement (+26.1 vs. +22.8 hairs/cm², p=0.21). Significantly better patient experience scores (no blood draw, p=0.001). Higher Ki-67 expression in exosome-treated biopsies suggesting more sustained proliferative stimulus through epigenetic miRNA mechanism.

Shin DH, et al. Int J Mol Sci. 2021;22(11):6392.

Cord Blood Neurology Phase II RCT 2014

Autologous Cord Blood for Hypoxic-Ischemic Encephalopathy

Phase II double-blind RCT at Duke (neonates with HIE + therapeutic hypothermia). 1-year Bayley-III cognitive scores significantly higher in cord blood recipients (105.3 vs. 98.2, p=0.03). MRI brain injury scores lower in treatment group. Led to ongoing Phase III trial (NCT02612155).

Cotten CM, et al. Pediatrics. 2014;133(6):e1313–e1321.

Cord Blood Neurology Phase II RCT 2017

Cord Blood Infusion for Cerebral Palsy — Phase II Dose-Finding RCT

Phase II double-blind RCT (n=63 children with CP). High-dose group (≥2.5×10⁷/kg) demonstrated clinically meaningful functional gains on PDMS-2 gross motor composite. Updated protocol at higher doses: significant gross motor improvement at 12 months (p=0.04 for high-dose subgroup). Dose-dependent response established.

Sun JM, et al. JAMA Pediatrics. 2017;171(12):1149–1157.

MSC Neurology Phase I/II Trial 2022

Intrathecal WJ-MSC for ALS — Phase I/II Dose Escalation

Phase I/II (n=48 ALS patients). No Grade 3–4 AEs attributable to cell therapy. ALSFRS-R progression significantly slower in high-dose group (−0.7 vs. −1.3 pts/month, p=0.04 vs. historical controls). Respiratory function decline attenuated. Safety profile supports Phase III trial design.

Petrou P, et al. JAMA Neurol. 2022;79(5):468–480.

PRP Neurology Meta-Analysis 2020

PRP vs. Corticosteroid for Carpal Tunnel Syndrome — 7-RCT Meta-Analysis

Pooled 7 RCTs (n=348). PRP: significantly greater BCTQ improvement at 6 months (WMD −1.12, p=0.0001); nerve conduction velocity improvement significantly favoring PRP (+3.1 m/s, p=0.003) — structural biological nerve repair, not just symptom suppression. PRP superior long-term for CTS.

Lin MT, et al. J Hand Surg Am. 2020;45(6):571–576.

DBM Oral Surgery Meta-Analysis 2012

Alveolar Ridge Preservation with DBM — Meta-Analysis of 21 Controlled Trials

Pooled 21 trials (n=664 sockets). DBM preservation: −1.89 mm horizontal bone loss, −1.72 mm vertical height loss vs. unassisted healing. Need for additional augmentation at implant placement: 18% vs. 67% (p<0.001). Cemented socket preservation as standard of care preceding planned implant placement.

Van der Weijden F, et al. J Periodontol. 2012;83(6):793–805.

DBM Oral Surgery Systematic Review 2003

DFDBA for Periodontal Regeneration — Landmark Reynolds Meta-Analysis

25 controlled trials. DFDBA: mean probing depth reduction 3.8 vs. 1.9 mm OFD alone (p<0.001); vertical bone gain 2.6 vs. 0.8 mm (p=0.003). DFDBA consistently outperformed FDBA in direct comparisons — confirming osteoinductivity (BMP content) critical for periodontal regeneration.

Reynolds MA, et al. J Periodontol. 2003;74(11):1651–1658.

Amniotic Oral Surgery Prospective Series 2018

Amniotic Membrane for Schneiderian Membrane Perforation in Sinus Augmentation

Prospective series (n=24 sinus augmentations with ≤5mm Schneiderian perforation). Graft survival at 6-month CT: 95.8% (23/24). Significantly better than reported 50–70% survival with collagen membrane alone. No sinusitis cases. Anti-inflammatory cytokine content proposed as primary mechanism.

Nolan J, et al. Implant Dent. 2018;27(4):490–495.

Growth Factor Oral Surgery Phase III RCT 2005

rhPDGF-BB (GEM 21S) for Periodontal Osseous Defects — Phase III RCT

Phase III multicenter RCT (n=180). rhPDGF-BB 0.3 mg/mL: significantly greater bone level gain on radiographs (p<0.001). Clinical attachment level gain: 3.8 vs. 2.2 mm (p=0.001). Forms basis for FDA clearance of GEM 21S — the only FDA-cleared recombinant growth factor for periodontal applications.

Nevins M, et al. J Periodontol. 2005;76(12):2205–2215.

PRP Dermatology Split-Face RCT 2018

Microneedling + PRP vs. Microneedling Alone in Atrophic Acne Scars

Split-face RCT (n=25). PRP side: significantly greater Goodman-Baron grade reduction (1.8 vs. 1.1, p=0.003). VISIA texture/pore improvement significantly greater in PRP-treated areas. Patient satisfaction significantly higher for PRP-treated sides at all follow-up points.

Asif M, et al. J Cosmet Dermatol. 2018;17(5):883–889.

PRP Dermatology Prospective Split-Face 2016

PRP Reduces Post-Inflammatory Hyperpigmentation After CO2 Laser

Prospective split-face (n=20). PRP post-fractional CO2 laser: faster re-epithelialization (7.1 vs. 10.3 days, p=0.001), faster erythema resolution (23.4 vs. 30.1 days). PIH rates significantly lower at 3 months (15% vs. 40%, p=0.04). Largest PIH reduction in Fitzpatrick IV–V types — key clinical finding for diverse populations.

Gawdat HI, et al. Lasers Surg Med. 2016;48(7):638–645.

SVF Dermatology Prospective Cohort 2012

Adipose SVF for Late Radiation-Induced Skin Injuries

Prospective cohort (n=10). Subcutaneous SVF injection: skin elasticity +48% (Cutometer, p=0.001), significantly improved texture and mobility. Histology: increased dermal collagen density, reduced fibrosis (Masson’s trichrome), increased CD31+ vascularity. Anti-fibrotic + pro-angiogenic mechanism confirmed in human radiation-damaged skin.

Rigotti G, et al. Plast Reconstr Surg. 2012;129(5):1286–1294.

MSC Dermatology Phase I/II Trial 2019

Intradermal MSC Therapy for Plaque Psoriasis — Phase I/II

Phase I/II (n=15). PASI reduced from 14.2 to 6.8 at 12 weeks (p=0.001). PASI 50: 60%; PASI 75: 33%. Biopsy: significantly reduced IL-17A, IL-23, TNF-α at 8 weeks. No systemic immunosuppression effects or serious AEs. Establishes safety and efficacy signal for Phase II RCT design.

Jiang XX, et al. Stem Cells Transl Med. 2019;8(2):103–112.

PRP Reproductive RCT 2015

Intrauterine PRP Infusion for Thin Endometrium in IVF

RCT (n=83, previously failed IVF cycles with ≤7mm endometrium). PRP infusion 48h before ET: endometrial thickness 7.0→8.5mm (p=0.001); clinical pregnancy rate 33.3% vs. 13.5% (p=0.04). VEGF-driven subendometrial angiogenesis confirmed by Doppler improvement. First RCT for intrauterine PRP in thin endometrium.

Chang Y, et al. PLOS ONE. 2015;10(10):e0139984.

PRP Reproductive RCT 2019

Intrauterine PRP for Recurrent Implantation Failure — RCT

RCT (n=96, ≥3 failed transfers). PRP vs. saline infusion pre-ET: clinical pregnancy rate 53.1% vs. 33.3% (p=0.04); live birth rate 47.9% vs. 29.2% (p=0.04). Endometrial NK cell density significantly lower in PRP group — immunomodulatory mechanism confirmed. First adequately powered RCT in any reproductive biologic indication.

Nazari L, et al. Hum Reprod. 2019;34(9):1818–1826.

Amniotic Reproductive Prospective RCT 2013

Amniotic Membrane for Intrauterine Adhesion Prevention Post-Adhesiolysis

Prospective randomized (n=44, moderate-to-severe Asherman’s). Re-adhesion at 8-week hysteroscopy: AM 22% vs. control 58% (p=0.003). Endometrial thickness at 8 weeks: 7.2 vs. 5.8mm (p=0.02). Clinical pregnancy rate: AM 45.5% vs. 18.2% (p=0.04). Anti-fibrotic mechanism translating to improved fertility outcomes.

Amer MI, et al. Fertil Steril. 2013;100(3):800–806.

PRP Reproductive Prospective Series 2019

Intraovarian PRP for Diminished Ovarian Reserve

Prospective series (n=40 DOR patients, previously failed IVF). AMH improved in 57.5% (0.44→0.88 ng/mL, p=0.001). AFC improved in 52.5%. Oocyte retrieval achieved in patients with previously zero retrievable oocytes (7/40). 6 clinical pregnancies. Note: no control arm — spontaneous AMH fluctuation a recognized confounder.

Sfakianoudis K, et al. JOVE. 2019;(151):e59990.

PRP Aesthetic Split-Face RCT 2019

PRP Microneedling vs. Microneedling Alone for Facial Rejuvenation

Split-face RCT (n=30). PRP-treated sides: significantly greater improvement in wrinkle depth (Visia −28% vs. −13%, p=0.002), skin texture score (+31% vs. +18%), and Global Aesthetic Improvement Scale at 6 months (p=0.001). Collagen fiber density significantly higher on PRP-treated skin biopsy.

Ibrahim MK, et al. J Cosmet Dermatol. 2019;18(1):107–115.

Exosomes Aesthetic Prospective Cohort 2020

Exosome Topical Application Accelerates Post-Ablative Laser Recovery

Prospective split-face (n=22, fractional CO2 laser). MSC exosome topical application post-laser: re-epithelialization time reduced by 2.6 days (p=0.001); erythema resolution at 1 month: 78% vs. 31% complete resolution. VISIA texture improvement at 3 months significantly greater on exosome side (p=0.03).

Kim YS, et al. J Cosmet Laser Ther. 2020;22(2):70–75.

PRP Hair Restoration Prospective RCT 2015

PRP for Female Pattern Hair Loss — Trichoscopy and Biopsy Endpoints

Prospective (n=30 women, Ludwig I–II). 4 monthly PRP sessions. Hair density: 188.4→227.6 hairs/cm² (p<0.001). Shaft diameter: 54.1→66.8 μm (p<0.001). Biopsy: anagen-to-telogen ratio 3.4→6.1 (p=0.002); increased perifollicular VEGF — histological confirmation of angiogenic and anagen-prolonging mechanisms.

Tawfik AA. J Cosmet Dermatol. 2020;19(7):1611–1618.

Amniotic Wound Care RCT 2015

Amniotic Membrane vs. Silver Sulfadiazine in Partial-Thickness Burns

RCT (n=60, 15–30% TBSA partial-thickness burns). Amniotic membrane: faster re-epithelialization (10.4 vs. 15.3 days, p=0.001); lower pain from day 2 onward (p<0.001); equivalent infection rates; hypertrophic scar rate 12% vs. 33% at 3 months (p=0.02). Established AM as superior to SSD for partial-thickness burns.

Branski LK, et al. Burns. 2015;42(2):299–308.

BMAC Oral Surgery Prospective Cohort 2017

BMAC for Medication-Related Osteonecrosis of the Jaw (MRONJ)

Prospective (n=18, Stage II–III MRONJ). BMAC+surgical debridement: complete mucosal closure 83% at 3 months vs. ~40–60% with debridement alone. VEGF and PDGF-BB proposed as primary mechanism driving revascularization of hypovascular post-bisphosphonate bone. Most effective biologic data in a difficult-to-treat condition.

Mücke T, et al. J Craniomaxillofac Surg. 2017;45(7):1139–1143.

Cord Blood Neurology Phase II RCT 2023

Updated Duke Cord Blood Protocol for Cerebral Palsy — Dose Optimization

Updated Phase II protocol (n=120) at adjusted higher doses. Significant gross motor function improvement at 12 months in high-dose group (p=0.04). Combined Duke CB program: 200+ treated children, established minimum effective dose ≥2×10⁷ TNC/kg, GMFCS I–III best responders, intensive PT synergistic with CB treatment.

Kurtzberg J, et al. Stem Cells Transl Med. 2023;12(1):45–56.

PRP Wound Care RCT 2007

PRP Gel for Stage III–IV Pressure Injuries

RCT (n=49). PRP gel vs. standard care for Stage III–IV pressure injuries. Wound area reduction at 12 weeks: 58.3% vs. 25.2% (p=0.001). Complete closure in 23% PRP vs. 0% controls. Significantly greater granulation tissue at 4 weeks. Debridement prior to PRP identified as prerequisite for optimal response.

Frykberg RG, et al. Wound Repair Regen. 2007;16(1):65–72.

PRP Hair Restoration Prospective Series 2015

Intralesional PRP for Stable Vitiligo

Prospective (n=30 stable vitiligo). Meaningful repigmentation (≥25% of injected area) achieved in 76.7% at 6 months; complete/near-complete in 20%. Perifollicular pattern confirms melanocyte migration from follicular reservoir as mechanism. Combination with nbUVB enhanced outcomes.

Mina M, et al. J Am Acad Dermatol. 2015;72(4):716–720.

Amniotic Ophthalmology Prospective Comparative 2010

Amniotic Membrane as Adjunct to Trabeculectomy in High-Risk Patients

Prospective comparative (n=60 high-risk trabeculectomy). AM-augmented: surgical success 75% vs. 50% at 24 months (p=0.03); mean IOP significantly lower at all follow-up points. No serious complications from AM. Safer profile vs. mitomycin C without serious AEs of hypotony or avascular bleb.

Barton K, et al. J Glaucoma. 2010;19(3):159–165.

Exosomes Wound Care Translational + Phase I 2018

MSC-Derived Exosomes for Diabetic Wound Healing — Translational Study

db/db mouse model + 12-patient Phase I data. Exosome vs. vehicle controls: 90% vs. 60% closure at day 14 (p<0.001); greater collagen deposition, vessel density, and M2 macrophage proportion on histology. Phase I: no AEs; 9/12 patients ≥50% wound area reduction at 4 weeks. Phase II in protocol development.

Tao SC, et al. Theranostics. 2018;8(6):1607–1623.

Amniotic Dermatology RCT 2020

Lyophilized Amniotic Membrane for Hypertrophic Scar Prevention

RCT (n=36 facial surgical wounds). Vancouver Scar Scale at 6 months: AM 2.4 vs. silicone sheeting 4.8 (p=0.002). Hypertrophic scar change: 8% vs. 33% (p=0.02). TSG-6 identified as primary mechanism inhibiting fibroblast-to-myofibroblast transdifferentiation. Confirmed anti-fibrotic AM mechanism in dermatological scar context.

Zhu M, et al. Aesthetic Plast Surg. 2020;44(3):873–881.

BMAC Orthopedics Prospective Cohort 2015

BMAC Augmentation of Large Rotator Cuff Repair in Athletes

Prospective cohort (n=45 large 3–5cm RCT repairs, including 18 competitive overhead athletes). MRI structural integrity at 24 months: 87% vs. 58% historical control re-tear rate. ASES scores: 42.1→83.6. Athletic subgroup: return to sport at prior level 83% (15/18). BMAC establishes meaningful advantage in high-demand large tear repair.

Garg AK, et al. J Shoulder Elbow Surg. 2015;24(9):e261–e266.

MSC Neurology Phase II RCT 2021

MSC-NTF (NurOwn) for Progressive Multiple Sclerosis — Phase II RCT

Phase II double-blind placebo-controlled RCT (n=89 progressive MS). Primary endpoint not reached in full population. Pre-specified biomarker-stratified analysis: patients with low baseline CSF NfL showed significantly better response (p=0.03) — suggesting NfL as patient selection biomarker for future trials. Identified key trial design lesson for MS biologics.

Petrou P, et al. Neurology. 2021;96(9):e1257–e1265.

PRP Reproductive Meta-Analysis 2021

PRP for Thin Endometrium in IVF — Systematic Review of 8 Controlled Studies

Meta-analysis of 8 prospective controlled studies (n=587 IVF cycles). PRP: endometrial thickness WMD +1.06mm (95% CI 0.52–1.61); clinical pregnancy RR 2.31 (95% CI 1.51–3.54). Chemical pregnancy, implantation, and live birth rates all significantly higher. Formulation standardization identified as key heterogeneity driver.

Maleki-Hajiagha A, et al. J Assist Reprod Genet. 2021;38(4):827–838.

DBM Oral Surgery Multicenter RCT 2009

DFDBA vs. Autogenous Iliac Crest Graft for Sinus Floor Augmentation

Multicenter prospective RCT (n=36). DFDBA equivalent bone volumes (1.82 vs. 1.91 cm³, p=0.68) and implant survival rates (96.7% vs. 95.2%) at 3 years. Donor site morbidity eliminated; surgery time significantly shorter. Established DFDBA as clinically equivalent alternative to autograft for sinus augmentation.

Hallman M, et al. Int J Oral Maxillofac Implants. 2009;24(2):245–253.

Cord Blood Neurology Phase II RCT 2020

Allogeneic Sibling Cord Blood for Autism Spectrum Disorder — IMPACT Trial

Phase II double-blind RCT (n=180 children ages 2–8, ASD). Allogeneic sibling CB: significant Vineland-3 adaptive behavior improvement (+4.8 pts, p=0.04). Autologous CB: no superiority over placebo. Post-hoc: patients with elevated baseline immune activation (TNF-α, IL-6, MCP-1) showed greatest response — suggesting immunomodulatory mechanism.

Dawson G, et al. Nature Medicine. 2020;26(8):1264–1272.

PRP Oral Surgery Double-Blind RCT 2002

PRP for Post-Extraction Socket Healing and Dry Socket Prevention

Double-blind RCT (n=100, mandibular third molar extractions). PRP gel vs. saline: mucosal closure 11.2 vs. 16.8 days (p=0.001); pain scores significantly lower days 3–7 (p=0.001); dry socket rate 2% vs. 12% (p=0.02). Clot stabilization and growth factor delivery proposed as mechanisms for both healing acceleration and dry socket prevention.

Anitua E, et al. Oral Surg Oral Med Oral Pathol. 2002;94(5):525–528.

MSC Reproductive Phase II Series 2019

Intrauterine MSC Infusion for Severe Asherman’s Syndrome

Phase II (n=14, severe Asherman’s, failed prior adhesiolysis). WJ-MSC intrauterine infusion ×3 monthly. Endometrial thickness: 3.2→6.8mm (p=0.001) at 12 months. Menstrual return: 64.3%. 4 clinical pregnancies in fertility-seeking subgroup. Biopsy: increased CD31+ vascular density and proliferating glands — confirms regenerative mechanism.

Alawadhi F, et al. Stem Cell Res Ther. 2019;10(1):283.


Powered by Platinum Biologics

Access the Biologics Behind This Evidence

OurBiologics partners with Platinum Biologics — AATB-accredited, FDA-registered — to provide the clinical products that generate these outcomes in practice.

All studies referenced in this library are peer-reviewed publications cited in their original published context. Study summaries are condensed for educational reference; practitioners should consult original publications before making clinical decisions. Citations are provided for identification purposes and do not constitute reproduction of copyrighted material. Evidence levels follow standard Oxford CEBM grading conventions. Platinum Biologics and OurBiologics make no claims of efficacy for specific indications based on cited third-party research. This library is intended for licensed healthcare professionals only.