NCT05484856

Prospective Single Centre, Open Label, Single Arm Clinical Study for Autologous Adipose Tissue Derived ADSCSs in Treatment of Patients With Osteoarthritis

Extracted Fields (from Registry)
Protocol IDNCT05484856
Registration Date2022-08-02
Statuscompleted
SponsorDr. Himanshu Bansal Foundation
CountryIndia
Industrynot industry
Blindingunblinded
Center Typesingel-center RCT
Scopenational RCT
First Patient In2016-05-16
Last Patient Out2021-02-25
Publicationn
Gender %ALL
Mean Age50 Years - 75 Years
LLM Classifications (Side-by-Side)
Field GLM
glm-5.1
8661ms / 10076 tok
CLAUDE
claude-sonnet-4-20250514
Thinking: claude-opus-4-20250514
6674ms / 11466 tok
OPENAI
gpt-4o
Thinking: o3
2966ms / 9865 tok
Review
rct_type N/A N/A N/A OK
cancer_status non-cancer non-cancer non-cancer OK
non_cancer_spec N/A N/A N/A OK
setting_patient outpatient outpatient outpatient OK
setting_place other hospital → other
shaky reasoning
✓ Unanimous Initial: hospital Requery: other — The trial explicitly targets outpatients, and the procedure involves same-day interventions like liposuction, centrifugation, and an intra-articular injection which are typically delivered in an ambulatory or outpatient clinic setting rather than requiring hospital admission.
other other → other → other
shaky reasoning
✓ Unanimous Initial: other Requery: other — This is a single-center outpatient study delivering intra-articular injections at a medical facility, which represents an outpatient clinic setting rather than requiring hospitalization. Thinking: other — This is an outpatient clinic study where patients come for adipose tissue harvesting, intra-articular injections, and follow-up visits - eligibility explicitly requires 'outpatients' and no hospitalization is involved.
other other → hospital → other
shaky reasoning
✓ Unanimous Initial: other Requery: hospital — The intervention involving intra-articular injections of stromal vascular fraction was administered to patients, indicating a requirement for hospital-based facilities for these procedures. Thinking: other — The intra-articular cell injections were given to outpatients in an ambulatory clinic setting without hospital admission.
OK
feasibility N/A N/A → N/A
shaky reasoning
✓ Unanimous Initial: N/A Requery: N/A — This is a single-arm interventional study without a control group, meaning it is not a randomized controlled trial (RCT).
N/A fully powered RCT → N/A → N/A
shaky reasoning
✓ Unanimous Initial: fully powered RCT Requery: N/A — This is an observational study (single arm, open label) evaluating a treatment intervention rather than a randomized controlled trial. Thinking: N/A — Single-arm interventional study without randomization or control group, not an RCT
N/A fully powered RCT → fully powered RCT → N/A
shaky reasoning
✓ Unanimous Initial: fully powered RCT Requery: fully powered RCT — The trial investigates clinical effectiveness with a significant sample size of 140 participants, suggesting it is designed to detect treatment effects. Thinking: N/A — Single-arm interventional study without randomisation, therefore not an RCT.
OK
intervention_pharmacologic no yes → no
shaky reasoning
✓ Unanimous Initial: yes Requery: no — The experimental intervention consists of autologous adipose tissue-derived stromal cells and platelet-rich plasma, which are biological/cellular therapies and not pharmaceutical drugs or medications.
no no → no
shaky reasoning
✓ Unanimous Initial: no Requery: no — The experimental intervention involves autologous adipose tissue derived stromal cells (biological/cellular therapy) along with platelet rich plasma, which are both biological treatments rather than pharmacologic drugs or medications.
no yes → no
shaky reasoning
✓ Unanimous Initial: yes Requery: no — The intervention involves autologous adipose tissue-derived stromal cells, which are biological in nature, not a pharmacologic drug/medication.
OK
intervention_chemo_immuno_radio no no no OK
intervention_complementary no no no OK
intervention_device no no no OK
intervention_psychological no no no OK
intervention_complex no no no OK
intervention_acp no no no OK
intervention_music no no no OK
intervention_screening no no no OK
intervention_palliative no no no OK
intervention_education no no no OK
intervention_digital no no no OK
intervention_other no yes → no
shaky reasoning
✓ Unanimous Initial: yes Requery: no — The intervention involves the administration of adipose-derived stromal cells (stem cells) and platelet-rich plasma, which are biological agents that fit under the pharmacologic or chemo/immuno/radio categories.
no yes → no
shaky reasoning
✓ Unanimous Initial: yes Requery: no — This involves biological intervention using autologous adipose-derived stromal cells and platelet-rich plasma, which is a cellular therapy that falls outside the 'other' category.
no no → no
shaky reasoning
✓ Unanimous Initial: no Requery: no — The trial involves a biological intervention using autologous adipose tissue derived stromal cells which fits the category of complex interventions, thus not qualifying for 'intervention_other'.
OK
outcome_symptom yes yes yes OK
outcome_qol no no no OK
outcome_dignity no no no OK
outcome_cost no no no OK
outcome_other no yes → no
shaky reasoning
✓ Unanimous Initial: yes Requery: no — The primary and secondary outcomes, including pain, physical function (WOMAC), and imaging metrics (cartilage thickness, joint space width), all fall under the symptom and quality of life categories.
no yes → no
shaky reasoning
✓ Unanimous Initial: yes Requery: no — All outcomes measure symptom-related parameters (WOMAC score assessing pain/stiffness/function) and physical/structural measures related to the condition (cartilage thickness and joint space width), which fall within standard symptom/QoL categories for osteoarthritis treatment evaluation.
no no → no
shaky reasoning
✓ Unanimous Initial: no Requery: no — All outcomes are focused on symptom improvement and quality of life, as indicated by WOMAC scores, 6-minute walking distance, MRI, and joint space measurements, fitting the symptom/QoL categories.
OK
pharmacologic_sub N/A other → N/A
shaky reasoning
✓ Unanimous Initial: other Requery: N/A — The intervention consists of autologous adipose tissue-derived stromal cells (ADSCs) and platelet-rich plasma, which are cell-based and biological therapies rather than pharmacologic substances.
N/A N/A → N/A
shaky reasoning
✓ Unanimous Initial: N/A Requery: N/A — The intervention involves autologous adipose tissue derived stromal cells (biological cell therapy), which is a cellular/biological intervention rather than a pharmacologic drug intervention.
N/A other → N/A
shaky reasoning
✓ Unanimous Initial: other Requery: N/A — The intervention involves autologous adipose tissue-derived stromal cells, which are biological and not pharmacologic.
OK
Back to Studies