| Protocol ID | NCT05484856 |
| Registration Date | 2022-08-02 |
| Status | completed |
| Sponsor | Dr. Himanshu Bansal Foundation |
| Country | India |
| Industry | not industry |
| Blinding | unblinded |
| Center Type | singel-center RCT |
| Scope | national RCT |
| First Patient In | 2016-05-16 |
| Last Patient Out | 2021-02-25 |
| Publication | n |
| Gender % | ALL |
| Mean Age | 50 Years - 75 Years |
NCT05484856
Prospective Single Centre, Open Label, Single Arm Clinical Study for Autologous Adipose Tissue Derived ADSCSs in Treatment of Patients With Osteoarthritis
| 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 |